Clinical Trials in DR

Diabetic Retinopathy Clinical Studies

Diabetic retinopathy (DR) is a complication of diabetes that causes damage to the blood vessels of the retina; it is the most common cause of irreversible blindness in working-age Americans. [ASRS.2016]. Vascular endothelial growth factor (VEGF) plays a critical role in promoting angiogenesis and vascular leakage, and several different anti-VEGF agents have been studied in the management of DME, PDR and advanced NPDR.

This section lists the most relevant clinical studies in DR/DME; click on the study name to see more details about each particular study. To enhance visibility of graphs and tables, click on the image to enlarge for expanding viewing.

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References

ACCORD Study Group; ACCORD Eye Study Group, Chew EY, et al. Effects of Medical Therapies on Retinopathy Progression in Type 2 Diabetes. N Eng J Med. 2010;363:233-244.

Aiello LP; the DCCT/EDIC Study Group. Diabetic Retinopathy and Other Ocular Findings in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Diabetes Care. 2014; 37:17-23.

Aiello LP, Odia I, Glassman AR, et al. Comparison of Early Treatment Diabetic Retinopathy Study Standard 7-Field Imaging With Ultrawide-Field Imaging for Determining Severity of Diabetic Retinopathy. JAMA Ophthalmol. 2019;137:65-73.

American Society of Retina Specialists (ASRS). Diabetic retinopathy. https://www.asrs.org/patients/retinal-diseases/3/diabetic-retinopathy. Accessed February 17,2021.

Baker CW, Glassman AR, Beaulieu WT, et al. Effect of initial management with aflibercept vs laser photocoagulation vs observation on vision loss among patients with diabetic macular edema involving the center of the macula and good visual acuity: a randomized clinical trial. JAMA.2019; 321(19):1880-1894. doi:10.1001/jama.2019.5790

Boyer DS, Yoon YH, Belfort R, Jr., et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014;121(10):1904-1914. doi:10.1016/j.ophtha.2014.04.024

Bressler SB, Liu D, Glassman AR, et al. Change in Diabetic Retinopathy Through 2 Years: Secondary Analysis of a Randomized Clinical Trial Comparing Aflibercept, Bevacizumab, and Ranibizumab. JAMA Ophthalmol. 2017;135:558-568.

[DRSRG.1976] The Diabetic Retinopathy Study Research Group. Preliminary Report on Effects of Photocoagulation Therapy. Am J Ophthalmol. 1976;81:383-396.

Jhaveri CD, Glassman AR, Ferris FL, et al. Aflibercept monotherapy or bevacizumab first for diabetic macular edema. N Engl J Med. 2022;387:692-703. https://www.nejm.org/doi/10.1056/NEJMoa2204225

Keech AC, Mitchell P, Summanen PA, et al. Effect of Fenofibrate on the Need for Laser Treatment for Diabetic Retinopathy: A Randomised Controlled Trial. Lancet. 2007;370:1687-1697.

Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254. doi:10.1016/j.ophtha.2014.05.006

Singh RP. Management of High-risk Non-proliferative Diabetic Retinopathy Without Diabetic Macular Edema: Results From PANORAMA. Presented at AAO 2019.

Maturi RK, Glassman AR, Josic K, et al. Effect of intravitreous
anti–vascular endothelial growth factor vs sham treatment: The Protocol
for Diabetic Retinopathy: The Protocol W Randomized Clinical Trial. JAMA
Ophthalmol. 2021;139:701-712. https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2778074

Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical Efficacy of Intravitreal Aflibercept Versus Panretinal Photocoagulation for Best Corrected Visual Acuity in Patients with Proliferative Diabetic Retinopathy at 52 Week: A Multicentre, Single-Blinded, Randomised, Controlled, Phase 2b, Noninferiority Trial. Lancet. 2017;389:2193-2203.

Stratton IM, Kohner EH, Aldington SJ, et al. UKPDS 50: Risk factors for incidence and progression of retinopathy in type 2 diabetes over 6 years from diagnosis. Diabetologia. 2001;44:156-163.

Sun JK, Wang PW, Taylor S, Haskova Z. Durability of Diabetic Retinopathy Improvement with As-Needed Ranibizumab: Open-Label Extension of RIDE and RISE Studies. Ophthalmology. 2019;126:712-720.

Writing Committee for the Diabetic Retinopathy Clinical Research Network, et al. Panretinal photocoagulation vs Intravenous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015; 314:2137-2146.

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