Retina-Related Clinical Trials: A Resource Bibliography

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Chapter 94 Retina-Related Clinical Trials

A Resource Bibliography

Barbara S. Hawkins, Usha Chakravarthy

The subspecialty of Retina has probably seen some of the most innovative changes in the field of ophthalmology, largely owing to ground-breaking randomized clinical trials, with several or many centers typically participating, conducted to test novel treatment strategies in the management of diabetes, age-related macular degeneration, and retinal vaso-occlusive disease, among others. In previous decades, large clinical trials of interventions for retinal disorders laid the foundations for evidence-based clinical practice; foremost among these was the Diabetic Retinopathy Study, which was also one of the first initiatives of the National Eye Institute of the USA upon its creation as one of the National Institutes of Health. The Diabetic Retinopathy Study was one of the largest and best-conducted clinical trials of the safety and effectiveness of panretinal photocoagulation in diabetic retinopathy. This trial provided ophthalmologists with the evidence that was needed to show that proliferative diabetic retinopathy could be managed effectively with laser and also demonstrated the potential of the retinal community to generate the evidence base for treatment of retinal disorders through a networked approach. Since the Diabetic Retinopathy Study, the number of clinical trials in retinal disorders has burgeoned, with increasing sponsorship from industry and agencies in other countries. The purpose of this chapter is to provide the retinal specialist with a bibliography of publications in peer-reviewed journals from studies undertaken on the common retinal disorders of diabetes, age-related macular degeneration, and retinal vein occlusion, as well as other retinal disorders for which important clinical trials have been conducted. The organization of the citations is by retinal condition and then by specific randomized clinical trials or sets of trials, with clinical trials that focus on the same condition grouped together. The order of the conditions is chronologic by publication of findings from the first major clinical trial in each condition. Whenever a randomized trial was conducted as part of a larger study, preceded by a pilot study, or continued as an observational study, publications from the pilot study or selected publications from the larger study or observational study have been included in the bibliography for the clinical trial or set of clinical trials.

Diabetic retinopathy

Findings from several clinical trials of treatment or prevention of diabetic retinopathy are discussed in Chapters 47 (Nonproliferative diabetic retinopathy and diabetic macular edema) and 48 (Proliferative diabetic retinopathy).

Diabetic Retinopathy Study (DRS)

The historical importance of and other information about the DRS are described above. From 1972 through 1975, 1758 patients enrolled at DRS-participating centers.

Diabetic Retinopathy Study Research Group. Preliminary report on effects of photocoagulation therapy. Am J Ophthalmol 1976;81:383–96.

With 1732 patients enrolled and one eye of each patient assigned to photocoagulation, visual acuity of 5/200 or worse at two consecutive examinations 4 months apart was observed in 9% of untreated eyes versus 4% of treated eyes, leading to the decision to halt enrollment of new patients, to disseminate the findings to physicians, and to offer panretinal photocoagulation to all untreated eyes deemed to be at high risk of progression and vision loss.

Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy: the second report of Diabetic Retinopathy Study findings. Ophthalmology 1978;85:82–106.

A detailed analysis of findings for all patients enrolled confirmed that scatter photocoagulation compared to no treatment reduced severe visual acuity loss and reduced the rate of progression to more severe stages of proliferative diabetic retinopathy. Throughout 3 years of follow-up, treated eyes had approximately half the risk of visual acuity of 5/200 or worse at two or more consecutive examinations.

Diabetic Retinopathy Study Research Group. Four risk factors for severe visual loss in diabetic retinopathy: the third report from the Diabetic Retinopathy Study. Arch Ophthalmol 1979;97:654–5.

The four risk factors were: (1) presence of vitreous or preretinal hemorrhage; (2) presence of new vessels; (3) location of new vessels on or near the optic disc; and (4) severity of new vessels. Risk of severe visual acuity loss increased by the number of factors present.

Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy: a short report of long range results. Diabetic Retinopathy Study (DRS) report number 4. International Congress series no. 500, Diabetes 1979. In: Waldhausl WK, editor. Proceedings of the 10th Congress of the International Diabetes Federation. Amsterdam: Excerpta Medica; 1979. p. 789–94.

Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy: relationship of adverse treatment effects to retinopathy severity. Diabetic Retinopathy Study report no. 5. Dev Ophthalmol 1981;2:248–61.

Diabetic Retinopathy Study Research Group. Diabetic Retinopathy Study report number 6: Design, methods, and baseline results. Invest Ophthalmol Vis Sci 1981;21:149–208.

Diabetic Retinopathy Study Research Group. Diabetic Retinopathy Study report number 7: A modification of the Airlie House classification of diabetic retinopathy. Invest Ophthalmol Vis Sci 1981;21:210–26.

Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings. DRS report number 8. Ophthalmology 1981;88:583–600.

Knatterud GL. Mortality experience in the Diabetic Retinopathy Study. Isr J Med Sci 1983;19:424–8.

Ederer F, Podgor MJ, the Diabetic Retinopathy Study Research Group. Assessing possible late treatment effects in stopping a clinical trial early: a case study. Diabetic Retinopathy Study report no. 9. Control Clin Trials 1984;5:373–81.

Rand LI, Prud’homme GJ, Ederer F, et al. Factors influencing the development of visual loss in advanced diabetic retinopathy: Diabetic Retinopathy Study (DRS) report no. 10. Invest Ophthalmol Vis Sci 1985;26:983–91.

Kaufman SC, Ferris FL, Swartz M, et al. Intraocular pressure following panretinal photocoagulation for diabetic retinopathy: Diabetic Retinopathy report no. 11. Arch Ophthalmol 1987;105:807–9.

Ferris FL, Podgor MJ, Davis MD, et al. Macular edema in Diabetic Retinopathy Study patients. Diabetic Retinopathy Study report number 12. Ophthalmology 1987;94:754–60.

Kaufman SC, Ferris FL, Seigel DG, et al. Factors associated with visual outcome after photocoagulation for diabetic retinopathy: Diabetic Retinopathy Study report no. 13. Invest Ophthalmol Vis Sci 1989;30:23–8.

Diabetic Retinopathy Study Research Group. Indications for photocoagulation treatment of diabetic retinopathy: Diabetic Retinopathy Study report no. 14. Int Ophthalmol Clin 1987;27:239–53.

UK Multicentre Controlled Study

This randomized trial of xenon arc photocoagulation for diabetic maculopathy was conducted concurrently with the DRS; initial findings were published shortly after the first publication from the DRS. This multicenter trial was sponsored by the British Diabetic Association and the Wellcome Trust.

Multicentre Controlled Study Coordinating Committee. Photocoagulation treatment of diabetic maculopathy. Interim report of a multicentre controlled study. Lancet 1975;2:1110–3.

Photocoagulation with the xenon arc led to less deterioration in visual acuity than no treatment. Initiation of treatment was recommended before visual acuity was “seriously impaired.”

Multicentre Controlled Study Coordinating Committee. Proliferative diabetic retinopathy: treatment with xenon-arc photocoagulation. Interim report of multicentre controlled randomised controlled trial. Br Med J 1977;1:739–41.

Photocoagulation with the xenon arc led to less monocular blindness than no treatment. New vessels on the disc regressed more in treated eyes than in untreated eyes.

Diabetic Retinopathy Vitrectomy Study (DRVS)

The primary goal of the DRVS was to compare early vitrectomy with conventional management of severe vitreous hemorrhage secondary to diabetic retinopathy. Patient accrual began in October 1976 and ended in June 1983. The DRVS was sponsored by the National Eye Institute.

Diabetic Retinopathy Vitrectomy Study Research Group. Two-year course of visual acuity in severe proliferative diabetic retinopathy with conventional management. Diabetic Retinopathy Vitrectomy Study (DRVS) report no. 1. Ophthalmology 1985;92:492–502.

After 2 years of follow-up, visual acuity of eyes assigned to conventional treatment was worse than 5/200 in 45% of eyes with more than four disc areas of new vessels and visual acuity of 10/30 to 10/50 at baseline.

Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized trial. Diabetic Retinopathy Vitrectomy Study report 2. Arch Ophthalmol 1985;103:1644–52.

Visual acuity was 10/20 or better in 25% of the early vitrectomy group compared with 15% of the deferral group 2 years after entry.

Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Results of a randomized trial – Diabetic Retinopathy Vitrectomy Study report 3. Ophthalmology 1988;95:1307–20.

Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Clinical application of results of a randomized trial – Diabetic Retinopathy Vitrectomy Study report 4. Ophthalmology 1988;95:1321–34.

Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial: Diabetic Retinopathy Vitrectomy Study report 5. Arch Ophthalmol 1990;108:958–64, 1452.

Early Treatment Diabetic Retinopathy Study (ETDRS)

The ETDRS was designed to evaluate the effectiveness of laser photocoagulation and aspirin, together and singly, in delaying or preventing progression of early diabetic retinopathy to more severe stages and blindness and to determine the optimum time to initiate photocoagulation in diabetic retinopathy. This multicenter clinical trial was sponsored by the National Eye Institute. Initiation of the ETDRS was a motivating factor in the development of a new visual acuity chart for use in prospective clinical research studies; see articles that report on the design and evaluation of the chart at the end of the ETDRS bibliography.

Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol 1985;103:1796–806.

Eyes with clinically significant macular edema benefited from focal photocoagulation and were about half as likely to lose three or more lines of vision as eyes assigned to deferral of photocoagulation.

Early Treatment Diabetic Retinopathy Study Research Group. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 2. Ophthalmology 1987;94:761–74.

Early Treatment Diabetic Retinopathy Study Research Group. Techniques for scatter and local photocoagulation treatment of diabetic retinopathy: Early Treatment Diabetic Retinopathy Study report no. 3. Int Ophthalmol Clin 1987;27:254–64.

Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report no. 4. Int Ophthalmol Clin 1987;27:265–72.

This report summarizes ETDRS reports number 1 and number 2.

Early Treatment Diabetic Retinopathy Study Research Group. Case reports to accompany Early Treatment Diabetic Retinopathy Study reports 3 and 4. Int Ophthalmol Clin 1987;27:273–334.

Kinyoun J, Barton F, Fisher M et al. Detection of diabetic macular edema: ophthalmoscopy versus photography – Early Treatment Diabetic Retinopathy Study report number 5. Ophthalmology 1989;96:746–51.

Prior MJ, Prout T, Miller D, et al. C-peptide and the classification of diabetes mellitus patients in the Early Treatment Diabetic Retinopathy Study: report number 6. Ann Epidemiol 1993;3:9–17.

Early Treatment Diabetic Retinopathy Study Research Group. Early Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7. Ophthalmology 1991;98:741–56.

Early Treatment Diabetic Retinopathy Study Research Group. Effects of aspirin treatment on diabetic retinopathy: ETDRS report number 8. Ophthalmology 1991;98:757–65.

Aspirin (650 mg/day) had no clinically beneficial or harmful effects in patients with retinopathy.

Early Treatment Diabetic Retinopathy Study Research Group. Early photocoagulation for diabetic retinopathy: ETDRS report number 9. Ophthalmology 1991;98:766–85.

Initiation of scatter photocoagulation was recommended for eyes with high-risk proliferative retinopathy. Whenever possible, scatter photocoagulation should be applied after completion of focal laser in eyes with macular edema.

Early Treatment Diabetic Retinopathy Study Research Group. Grading diabetic retinopathy from stereoscopic color fundus photographs – an extension of the modified Airlie House classification. ETDRS report number 10. Ophthalmology 1991;98:786–806.

Early Treatment Diabetic Retinopathy Study Research Group. Classification of diabetic retinopathy from fluorescein angiograms. ETDRS report number 11. Ophthalmology 1991;98:807–22.

Early Treatment Diabetic Retinopathy Study Research Group. Fundus photographic risk factors for progression of diabetic retinopathy: ETDRS report number 12. Ophthalmology 1991;98:823–33.

Severity of intraretinal microvascular abnormalities, hemorrhages and/or microaneurysms, and venous beading were the most important factors in predicting progression to proliferative diabetic retinopathy.

Early Treatment Diabetic Retinopathy Study Research Group. Fluorescein angiographic risk factors for progression of diabetic retinopathy: ETDRS report number 13. Ophthalmology 1991;98:834–40.

Fluorescein leakage, capillary loss and dilation, and various arteriolar abnormalities were associated with progression to proliferative retinopathy.

Early Treatment Diabetic Retinopathy Study Investigators. Aspirin effects on mortality and morbidity in patients with diabetes mellitus: Early Treatment Diabetic Retinopathy Study report 14. JAMA 1992;268:1292–300.

Fong DS, Barton FB, Bresnick GH, et al. Impaired color vision associated with diabetic retinopathy: Early Treatment Diabetic Retinopathy Study report no. 15. Am J Ophthalmol 1999;128:612–7.

Chew EY, Williams GA, Burton TC, et al. Aspirin effects on the development of cataracts in patients with diabetes mellitus: Early Treatment Diabetic Retinopathy Study report 16. Arch Ophthalmol 1992;110:339–42.

Flynn HW, Chew EY, Simons BD, et al. Pars plana vitrectomy in the Early Treatment Diabetic Retinopathy Study. ETDRS report number 17. Ophthalmology 1992;99:1351–7.

Ferris FL. Early photocoagulation in patients with either type I or type II diabetes. Trans Am Ophthalmol Soc 1996;94:505–36.

Patients with type 2 diabetes were more likely to benefit from early scatter photocoagulation than patients with type 1 diabetes based on analysis of data from both the DRS and ETDRS.

Davis MD, Fisher MR, Gangnon RE, et al. Risk factors for high-risk proliferative diabetic retinopathy and severe visual loss: Early Treatment Diabetic Retinopathy Study report no. 18. Invest Ophthalmol Vis Sci 1998;39:233–52.

Early Treatment Diabetic Retinopathy Study Research Group. Focal photocoagulation treatment of diabetic macular edema. Relationship of treatment effect to fluorescein angiographic and other retinal characteristics at baseline: ETDRS report no. 19. Arch Ophthalmol 1995;113:1144–55.

Chew EY, Klein ML, Murphy RP, et al. Effects of aspirin on vitreous/preretinal hemorrhage in patients with diabetes mellitus: Early Treatment Diabetic Retinopathy Study report no. 20. Arch Ophthalmol 1995;113:52–5.

Braun CI, Benson WE, Remaley NA, et al. Accommodative amplitudes in the Early Treatment Diabetic Retinopathy Study. ETDRS report number 21. Retina 1995;15:275–81.

Chew EY, Klein ML, Ferris FL, et al. Association of elevated serum lipid levels with retinal hard exudate in diabetic retinopathy: Early Treatment Diabetic Retinopathy Study (ETDRS) report 22. Arch Ophthalmol 1996;114:1079–84.

Fong DS, Segal PP, Myers F, et al. Subretinal fibrosis in diabetic macular edema. ETDRS report 23. Arch Ophthalmol 1997;115:873–7.

Fong DS, Ferris FL, Davis MD, et al. Causes of severe visual loss in the Early Treatment Diabetic Retinopathy Study: ETDRS report no. 24. Am J Ophthalmol 1999;127:137–41.

Chew EY, Benson WE, Remaley NA, et al. Results after lens extraction in patients with diabetic retinopathy: Early Treatment Diabetic Retinopathy Study report number 25. Arch Ophthalmol 1999;117:1600–6.

Cusick M, Chew EY, Hoogwert B, et al. and the ETDRS Research Group. Risk factors for renal replacement therapy in the Early Treatment Diabetic Retinopathy Study (ETDRS). ETDRS report no. 26. Kidney International 2004;66:1173–9.

Cusick M, Davis MD, Meleth AD, et al for the Early Treatment Diabetic Retinopathy Study (ETDRS) Research Group. Associations of mortality and diabetes complications in patients with type 1 and type 2 diabetes. Early Treatment Diabetic Retinopathy Study report no. 27. Diabetes Care 2005;28:617–25.

Barton FB, Fong DS, Knatterud GL, et al. Classification of Farnsworth–Munsell 100-hue test results in the Early Treatment Diabetic Retinopathy Study. Am J Ophthalmol 2004;138:119–24.

Gangnon RE, Davis MD, Hubbard LD, et al. A severity scale for diabetic macular edema developed from ETDRS data. Invest Ophthalmol Vis Sci 2008;49:5041–7.

Ferris FL, Kassoff A, Bresnick GH, et al. New visual acuity charts for clinical research. Am J Ophthalmol 1982;94:91–6.

Ferris FL, Sperduto RD. Standardized illumination for visual acuity testing in clinical research. Am J Ophthalmol 1982;94:97–8.

Ferris FL, Freidlin V, Kassoff A, et al. Relative letter and position difficulty on visual acuity charts from the Early Treatment Diabetic Retinopathy Study. Am J Ophthalmol 1993;116:735–40.

Sorbinil Retinopathy Trial (SRT)

The SRT was sponsored by the National Eye Institute and by Pfizer.

Sorbinil Retinopathy Trial Research Group. A randomized trial of sorbinil, an aldose reductase inhibitor, in diabetic retinopathy. Arch Ophthalmol 1990;108:1234–44.

Sorbinil, as administered in the SRT, did not have a clinically important effect on the course of diabetic retinopathy in adults with insulin-dependent diabetes.

Sorbinil Retinopathy Trial Research Group. The Sorbinil Retinopathy Trial: neuropathy results. Neurology 1993;43:1141–9.

Cohen RA, Hennekens CH, Christen WG, et al. Determinants of retinopathy progression in type 1 diabetes mellitus. Am J Med 1999;107:45–51.

Christen WG, Manson JE, Bubes V, et al. Risk factors for progression of distal symmetric polyneuropathy in type 1 diabetes mellitus. Am J Epidemiol 1999;150:1142–51.

Krypton Argon Regression of Neovascularization Study (KARNS)

The KARNS was a multicenter clinical trial with the primary goal of comparing krypton red laser with argon blue–green laser for panretinal photocoagulation with respect to regression of disc neovascularization in diabetic retinopathy.

Singerman LJ, Ferris FL, Mowery RP, et al. Krypton laser for proliferative diabetic retinopathy: the Krypton Argon Regression of Neovascularization Study. J Diab Complications 1988;2:189–96.

Krypton Argon Regression of Neovascularization Study Research Group. Randomized comparison of krypton versus argon scatter photocoagulation for diabetic disc neovascularization. Ophthalmology 1993;100:1655–64.

Scatter photocoagulation with either krypton red or argon blue–green laser was equally effective in the treatment of proliferative diabetic retinopathy.

Diabetes Control and Complications Trial (DCCT)

The DCCT was a multicenter randomized clinical trial designed to compare intensive with conventional glucose control with respect to development and progression of early vascular and neurologic complications of insulin-dependent diabetes mellitus. The DCCT was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Heart, Lung, and Blood Institute, the National Eye Institute, and the National Center for Research Resources (National Institutes of Health, US Department of Health and Human Services) and various corporate sponsors. A follow-up study of members of the DCCT cohort, the Epidemiology of Diabetes Interventions and Complications (EDIC), was undertaken to assess the long-term effects of intensive and conventional diabetes therapy during the DCCT.

Diabetes Control and Complications Trial Research Group. The Diabetes Control and Complications Trial (DCCT): design and methodologic considerations for the feasibility phase. Diabetes 1986;35:530–45.

Diabetes Control and Complications Trial Research Group. The Diabetes Control and Complications Trial (DCCT): Results of feasibility study. Diabetes Care 1987;10:1–10.

Diabetes Control and Complications Trial Research Group. Feasibility of centralized measurements of glycated hemoglobin in the Diabetes Control and Complications Trial, a multicenter study. Clin Chem 1987;33:2267–71.

Diabetes Control and Complications Trial Research Group. Implementation of a multicomponent process to obtain informed consent in the Diabetes Control and Complications Trial. Control Clin Trials 1989;10:83–96.

Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–86.

Relative to rates in the conventional treatment arm, intensive therapy reduced onset and progression of diabetic retinopathy by 76% and 54%, respectively, occurrence of nephropathy by 54%, and onset of neuropathy by 60%.

Diabetes Control and Complications Trial Research Group. Expanded role of the dietician in the Diabetes Control and Complications Trial: implications for clinical practice. J Am Diet Assoc 1993;93:758–64, 767.

Diabetes Control and Complications Trial Research Group. Nutrition interventions for intensive therapy in the Diabetes Control and Complications Trial. J Am Diet Assoc 1993;93:768–72.

Diabetes Control and Complications Trial Research Group. Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. J Pediatr 1994;125:177–88.

In the DCCT cohort of young patients (13–17 years old), intensive control reduced the risk of development and progression of retinopathy compared to conventional treatment by 53% and 70%, respectively.

Diabetes Control and Complications Trial Research Group. A screening algorithm to identify clinically significant changes in neuropsychological functions in the Diabetes Control and Complications Trial. J Clin Exp Neuropsychol 1994;16:303–16.

Diabetes Control and Complications Trial Research Group. The effect of intensive diabetes treatment on the progression of diabetic retinopathy in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial. Arch Ophthalmol 1995;113:36–51.

Intensive therapy significantly reduced the risk of a three-step progression of retinopathy to 12% compared to 54% in the conventional therapy group.

Diabetes Control and Complications Trial Research Group. Progression of retinopathy with intensive versus conventional treatment in the Diabetes Control and Complications Trial. Ophthalmology 1995;102:647–61.

Intensive therapy reduced the risk of development of any retinopathy to 70% from 90% in the conventional treatment arm and also reduced the risk of progression. Intensive therapy was most effective when initiated early after diagnosis of insulin-dependent diabetes mellitus.

Diabetes Control and Complications Trial Research Group. Implementation of treatment protocols in the Diabetes Control and Complications Trial. Diabetes Care 1995;18:361–76.

Diabetes Control and Complications Trial (DCCT) Research Group. Effect of intensive diabetes management on macrovascular events and risk factors in the Diabetes Control and Complications Trial. Am J Cardiol 1995;75:894–903.

Diabetes Control and Complications Trial Research Group. The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the Diabetes Control and Complications Trial. Diabetes 1995;44:968–83.

Diabetes Control and Complications Trial (DCCT) Research Group. Effect of intensive diabetes treatment on nerve conduction in the Diabetes Control and Complications Trial. Ann Neurol 1995;38:869–80.

Diabetes Control and Complications Trial Research Group. Influence of intensive diabetes treatment on quality-of-life outcomes in the Diabetes Control and Complications Trial. Diabetes Care 1996;19:195–203.

Diabetes Control and Complications Trial Research Group. The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial. Diabetes 1996;45:1289–98.

Diabetes Control and Complications Trial Research Group. Lifetime benefits and costs of intensive therapy as practiced in the Diabetes Control and Complications Trial. JAMA 1996;276:1400–15.

Diabetes Control and Complications Trial Research Group. Pregnancy outcomes in the Diabetes Control and Complications Trial. Am J Obstet Gynecol 1996;174:1343–53.

Diabetes Control and Complications Trial Research Group. Effect of intensive therapy on residual β-cell function in patients with type I diabetes in the Diabetes Control and Complications Trial. Ann Intern Med 1998;128:517–23.

Diabetes Control and Complications Trial Research Group. Early worsening of diabetic retinopathy in the Diabetes Control and Complications Trial. Arch Ophthalmol 1998;116:874–86.

Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Design, implementation, and preliminary results of a long-term follow-up of the Diabetes Control and Complications Trial cohort. Diabetes Care 1999;22:99–111.

Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Effect of intensive diabetes treatment on carotid artery wall thickness in the Epidemiology of Diabetes Interventions and Complications. Diabetes 1999;48:383–90.

Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Retinopathy and nephropathy in patients with type I diabetes four years after a trial of intensive therapy. N Engl J Med 2000;342:381–9.

The intensive therapy group continued to demonstrate a persistent reduction in the risk of progressive retinopathy and nephropathy compared to the conventional therapy group 4 years after the conclusion of the DCCT.

Diabetes Control and Complications Trial Research Group. Effect of pregnancy on microvascular complications in the Diabetes Control and Complications Trial. Diabetes Care 2000;23:1084–91.

Diabetes Control and Complications Trial (DCCT)/ Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Beneficial effects of intensive therapy of diabetes during adolescence: outcomes after the conclusion of the Diabetes Control and Complications Trial (DCCT). J Pediatr 2001;139:804–12.

Diabetes Control and Complications Trial Research Group. Influence of intensive diabetes treatment on body weight and composition of adults with type 1 diabetes in the Diabetes Control and Complications Trial. Diabetes Care 2001;24:1711–21.

Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA 2002;287:2563–9.

Diabetes Control and Complications Trials/Epidemiology of Diabetes Interventions and Complications Research Group. Intensive diabetes therapy and carotid intima-media thickness in type 1 diabetes mellitus. N Engl J Med 2003;348:2294–303.

Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) Study. JAMA 2003;290(16):2159–67.

Lyons TJ, Jenkins AJ, Zheng D, et al. Diabetic retinopathy and serum lipoprotein subclasses in the DCCT/EDIC cohort. Invest Ophthalmol Vis Sci 2004;45:910–8.

Nathan DM, Cleary PA, Backlund JY, et al. for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353(25):2643–53.

Steffes M, Cleary P, Goldstein D, et al. Hemoglobin A1c measurements over nearly two decades: sustaining comparable values throughout the Diabetes Control and Complications Trial and the Epidemiology of Diabetes Interventions and Complications Study. Clin Chem 2005;51(4):753–8.

Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Prolonged effect of intensive therapy on the risk of retinopathy complications in patients with type 1 diabetes mellitus. Arch Ophthalmol 2008;126(12):1707–15.

Hubbard LD, Sun W, Cleary PA, et al. for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Comparison of digital and film grading of diabetic retinopathy severity in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Arch Ophthalmol 2011;129(6):718–26.

UK Prospective Diabetes Study (UKPDS)

Since 1983, the UKPDS investigators have published more than 75 articles to report findings from this prospective study.

United Kingdom Prospective Diabetes Study Group. UK Prospective Study of Therapies of Maturity-Onset Diabetes. I: Effect of diet, sulphonylurea, insulin or biguanide therapy on fasting plasma glucose and body weight over 1 year. Diabetelogia 1983;24:404–11.

United Kingdom Prospective Study Group. United Kingdom Prospective Diabetes Study. III. Prevalence of hypertension and hypotensive therapy in patients with newly diagnosed diabetes. Hypertension 1985;7(Suppl 2):8–13.

United Kingdom Prospective Study Group. United Kingdom Prospective Diabetes Study. IV. Characteristics of newly-presenting type 2 diabetic patients: male preponderance and obesity at different ages. Diabetic Med 1988;5:154–9.

United Kingdom Prospective Diabetes Study Group. United Kingdom Prospective Diabetes Study. VI. Complications in newly diagnosed type 2 diabetic patients and their association with different clinical and biochemical risk factors. Diabetes Res 1990;13:1–11.

United Kingdom Prospective Diabetes Study Group. UK Prospective Diabetes Study (UKPDS): VIII. Study design, progress and performance. Diabetologia 1991;34:877–90.

United Kingdom Prospective Diabetes Study Group. UK Prospective Diabetes Study IX: Relationships of urinary albumin and N-acetylglucosaminidase to glycemia and hypertension at diagnosis of type 2 (non-insulin-dependent) diabetes mellitus and after 3 months diet therapy. Diabetologia 1992;36:835–42.

United Kingdom Prospective Diabetes Study Group. UK Prospective Diabetes Study (UKPDS) XII. Differences between Asian, Afro-Caribbean, and White Caucasian type 2 diabetic patients at diagnosis of diabetes. Diabetic Med 1994;11:670–7.

Kohner EM, Aldington SJ, Stratton IM, et al. United Kingdom Prospective Diabetes Study, 30: Diabetic retinopathy at diagnosis of non-insulin-dependent diabetes mellitus and associated risk factors. Arch Ophthalmol 1998;116:297–303.

United Kingdom Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837–53.

Over a 10-year period, a 25% risk reduction in microvascular endpoints was observed in the intensive treatment group (median hemoglobin (Hb) A1c 7.0%) compared with the conventional treatment group (median HbA1c 7.9%).

United Kingdom Prospective Diabetes Study (UKPDS) Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. Br Med J 1998;317:705–13.

Tight blood pressure control (mean, 144/82 mmHg) compared to lesser control (mean, 154/87 mmHg) reduced progression rates of diabetic retinopathy and deterioration of visual acuity.

United Kingdom Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. Br Med J 1998;317:713–20.

United Kingdom Prospective Diabetes Study Group. Cost effectiveness of improved blood glucose control in hypertensive patients with type 2 diabetes: UKPDS 40. Br Med J 1998;317:720–6.

Stratton IM, Kohner EM, Aldington SJ, et al. UKPDS 50: Risk factors for incidence and progression of retinopathy in type II diabetes over 6 years from diagnosis. Diabetologia 2001;44:156–63.

Of 1216 patients without retinopathy at diagnosis of type 2 diabetes, 22% had developed retinopathy (microaneurysms or worse in both eyes) by 6 years after diagnosis. HbA1c was strongly associated with incidence and, especially, progression of retinopathy. Incidence of retinopathy also was strongly associated with systolic blood pressure. Smoking was associated with a reduced incidence of retinopathy.

Gray A, Clarke P, Farmer A, et al. Implementing intensive control of blood glucose concentration and blood pressure in type 2 diabetes in England: cost analysis (UKPDS 63). Br Med J 2002;325:860–5.

UK Prospective Diabetes Study (UKPDS) Group. Risks of progression of retinopathy and vision loss related to tight blood pressure control in type 2 diabetes mellitus (UKPDS 69). Arch Ophthalmol 2004;122:1631–40.

Stratton IM, Cull CA, Adler AI, et al. Additive effects of glycaemia and blood pressure exposure on risk of complications in type 2 diabetes: a prospective observational study (UKPDS 75). Diabetologia 2006;49:1761–9.

Diabetic Retinopathy Clinical Research Network (DRCR.net)

The DRCR.net investigators have conducted a number of randomized clinical trials and observational studies of diabetic retinopathy. A complete list of publications from the DRCR.net is maintained on the DRCR.net Public Web Site (http://drcrnet.jaeb.org/Publications.aspx [cited 2012 27 Feb]).

Diabetic Retinopathy Clinical Research Network. Diurnal variation in retinal thickening measurement by optical coherence tomography in center-involved diabetic macular edema. Arch Ophthalmol 2006;124:1701–7.

Diabetic Retinopathy Clinical Research Network. Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema. Ophthalmology 2007;114:1520–5.

Diabetic Retinopathy Clinical Research Network. A phase 2 randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology 2007;114(10):1860–7.

Bhavsar AR, Ip MS, Glassman AR for the DRCRnet and the SCORE Study Group. The risk of enophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol 2007;144:454–6.

Writing Committee for the Diabetic Retinopathy Clinical Research Network. Comparison of the modified Early Treatment Diabetic Retinopathy Study and mild macular grid laser photocoagulation strategies for diabetic macular edema. Arch Ophthalmol 2007;124:469–80.

Bressler NM, Edwards AR, Antoszyk AN, et al. on behalf of the Diabetic Retinopathy Clinical Research Network. Retinal thickness on Stratus optical coherence tomography in people with diabetes and minimal or no diabetic retinopathy. Am J Ophthalmol 2008;145:894–901.

Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology 2008;115:1447–59.

Scott IU, Bressler NM, Bressler SB, et al. and the Diabetic Retinopathy Clinical Research Network. Agreement between clinician and reading center gradings of diabetic retinopathy severity level at baseline in a phase 2 study of intravitreal bevacizumab for diabetic macular edema. Retina 2008;28:38–40.

Browning DJ, Altaweel MM, Bressler NM, et al. on behalf of the Diabetic Retinopathy Clinical Research Network. Diabetic macular edema: What is focal and what is diffuse? Am J Ophthalmol 2008;146:649–55.

Diabetic Retinopathy Clinical Research Network. Three-year follow up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol 2009;127(3):245–51.

Bressler NM, Edwards AR, Beck RW, et al. for the Diabetic Retinopathy Clinical Research Network. Exploratory analysis of diabetic retinopathy progression through 3 years in a randomized clinical trial that compares intravitreal triamcinolone acetonide with focal/grid photocoagulation. Arch Ophthalmol 2009;127(12):1566–71.

Diabetic Retinopathy Clinical Research Network. Observational study of the development of diabetic macular edema following panretinal (scatter) photocoagulation given in 1 or 4 sittings. Arch Ophthalmol 2009;127(2):132–40.

Sun JK, Aiello LP, Stockman M, et al. for the Diabetic Retinopathy Clinical Research Network. Effects of dilation on electronic-ETDRS visual acuity (EVA) in diabetic patients. Invest Ophthalmol Vis Sci 2009;50(4):1580–4.

Diabetic Retinopathy Clinical Research Network Writing Committee. Vitrectomy outcomes in eyes with diabetic macular edema and vitreomacular traction. Ophthalmology 2010;117:1087–93.

Diabetic Retinopathy Clinical Research Network Writing Committee: Googe J, Brucker AJ, Bressler NM, et al. Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal/grid laser for diabetic macular edema in eyes also receiving panretinal photocoagulation. Retina 2011;31:1009–27.

Diabetic Retinopathy Clinical Research Network. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2010;117:1064–77.

Diabetic Retinopathy Clinical Research Network. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2011;118:609–14.

Other diabetic retinopathy trials

Chaturvedi N, Sjolie A-K, Stephenson JM, et al. and the EUCLID Study Group. Effect of lisinopril on progression of retinopathy in normotensive people with type 1 diabetes. Lancet 1998;351:28–31.

Keech AC, Mitchell P, Summanen PA, et al. for the FIELD study investigators. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Lancet 2007;370:1687–97.

Sjolie AK, Klein R, Porta M, et al. for the DIRECT Programme Study Group. Effect of candesartan on progression and regression of retinopathy in type 2 diabetes (DIRECT-Protect 2): a randomised placebo-controlled trial. Lancet 2008;372:1385–93.

Chaturvedi N, Porta M, Klein R, et al. for the DIRECT Programme Study Group. Effect of candesartan on prevention (DIRECT-Prevent 1) and progression (DIRECT-Protect 1) of retinopathy in type 1 diabetes: randomised, placebo-controlled trials. Lancet 2008;372:1394–402.

Stolk RP, Vingerling JR, Cruickshank JK, et al. on behalf of the AdRem project team and ADVANCE management committee. Rationale and design of the AdRem study: Evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus. Contemp Clin Trials 2007;28:6–17.

Stolk RP, Thom SAMcG, van Schooneveld MJ, et al. on behalf of the AdRem Project Team and ADVANCE Management Committee. Retinal vascular lesions in patients with Caucasian and Asian origin with type 2 diabetes. Baseline results from the ADVANCE Retinal Measurements (AdRem) study. Diabetes Care 2008;31:708–13.

Beulens JWJ, Patel A, Vingerling JR, et al. on behalf of the AdRem project team and ADVANCE management committee. Effects of blood pressure lowering and intensive glucose control on the incidence and progression of retinopathy in patients with type 2 diabetes mellitus: a randomised controlled trial. Diabetologia 2009;52:2027–36.

Lee CC, Stolk RP, Adler AI, et al. on behalf of the AdRem project team and ADVANCE management committee. Association between alcohol consumption and diabetic retinopathy and visual acuity – the AdRem Study. Diabet Med 2010;27:1130–7.

Chew EY, Ambrosium WT, Howard LT, et al. for the ACCORD Study Group. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol 2007;99(Suppl):103i-111i.

ACCORD Study Group and ACCORD Eye Study Group. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med 2010;363:233–44.

Ambrosius WT, Danis RP, Goff DC, et al. for the ACCORD Study Group. Lack of association between thiazolidinediones and macular edema in type 2 diabetes. Arch Ophthalmol 2010;128(3):312–8.

Ahmadieh H, Shoeibi N, Entezari M, et al. Intravitreal bevacizumab for prevention of early postvitrectomy hemorrhage in diabetic patients. A randomized clinical trial. Ophthalmology 2009;116:1943–8.

Gillies MC, Simpson JM, Gaston C, et al. Five-year results of a randomized trial with open-label extension of triamcinolone acetonide for refractory diabetic macular edema. Ophthalmology 2009;116:2182–7.

Nguyen QD, Shah SM, Heier JS, et al. for the READ-2 Study Group. Primary end point (six months) results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study. Ophthalmology 2009;116:2175–81.

Nguyen QD, Shah SM, Khwaja AA, et al. for the READ-2 Study Group. Two-year outcomes of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study. Ophthalmology 2010;117:2146–51.

Haller JA, Kuppermann BD, Blumenkranz MS, et al. for the Dexamethasone DDS Phase II Study Group. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol 2010;128(3):289–96.

Mitchell P, Bandello F, Schmidt-Erfurth U, et al. on behalf of the RESTORE study group. The RESTORE Study. Ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology 2011;118:615–25.

Vein occlusions

Cochrane Systematic Review

Braithwaite T, Nanji AA, Greenberg PB. Anti-vascular endothelial growth factor for macular edema secondary to central retinal vein occlusion. Cochrane Database of Systematic Review 2010, Issue 10, Art. No.: CD007325. DOI: 10.1002/14651858.CD007325.pub2.

Branch Vein Occlusion Study (BVOS)

The BVOS was a multicenter randomized clinical trial sponsored by the National Eye Instititue and designed to assess in eyes with retinal branch vein occlusion whether scatter photocoagulation with the argon laser could prevent development of neovascularization and peripheral scatter photocoagulation could prevent vitreous hemorrhage, and whether macular photocoagulation would improve visual acuity in eyes with macular edema and visual acuity of 20/40 or worse. BVOS findings are discussed in Chapter 53 Branch retinal vein occlusion.

Finkelstein D, Clarkson J, Diddie K, et al. Branch vein occlusion: retinal neovascularization outside the involved segment. Ophthalmology 1982;89:1357–61.

Branch Vein Occlusion Study Group. Argon laser photocoagulation for macular edema in branch vein occlusion. Am J Ophthalmol 1984;98:271–82.

Argon laser photocoagulation improved visual acuity in eyes with macular edema secondary to retinal branch vein occlusion, macular edema, and visual acuity of 20/40 or worse, with a gain of 2 or more lines of visual acuity in more laser-treated eyes than untreated eyes.

Branch Vein Occlusion Study Group. Argon laser scatter photocoagulation for prevention of neovascularization and vitreous hemorrhage in branch vein occlusion: a randomized clinical trial. Arch Ophthalmol 1986;104:34–41.

Peripheral scatter argon laser photocoagulation decreased the risk of vitreous hemorrhage compared to untreated eyes. In addition, scatter treatment before development of neovascularization was not beneficial; treatment after development of neovascularization was recommended.

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