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. [AAO 2024]. 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 diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), and advanced non-proliferative diabetic retinopathy (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.
More DR Clinical Studies
References
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema. Clinicaltrials.gov identifier: NCT04432831. Last update: October 30, 2024. https://clinicaltrials.gov/study/NCT04432831
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE). Clinicaltrials.gov identifier: NCT03622580. Last update September 16, 2022. https://clinicaltrials.gov/study/NCT03622580
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE). Clinicaltrials.gov identifier: NCT03622593. https://clinicaltrials.gov/study/NCT03622593
A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda). Clinicaltrials.gov identifier: NCT04108156. Last update: April 4, 2026. https://clinicaltrials.gov/study/NCT04108156
A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema. Clinicaltrials.gov identifier: NCT04429503. Last update: July 30, 2024. https://clinicaltrials.gov/study/NCT04429503
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, 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.
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.
American Society of Retina Specialists (ASRS). Diabetic retinopathy. https://www.asrs.org/patients/retinal-diseases/3/diabetic-retinopathy.
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.
Boyd K. Diabetic Retinopathy: Causes, Symptoms, Treatment. American Academy of Ophthalmology. October 11, 2024. https://www.aao.org/eye-health/diseases/what-is-diabetic-retinopathy
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.
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.
Brown D. Aflibercept 8 mg in diabetic macular edema: 156-week results from the PHOTON extension. Presented at the Macula Society 48th Annual Meeting; February 12-15, 2025; Charlotte Harbor, FL. https://regeneronmedical.com/view-content?id=a1bPr000002XhmjIAC&type=Publications&disease=AMD&ta=Ophthalmology&congress=The%20Macula%20Society%202025
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.
Khanani AM, Abreu F, Gibson K, et al. Four-year outcomes of faricimab in DME: first time safety and efficacy results from the RHONE-X long-term extension trial. Presented at the American Society of Retinal Specialists 2024 Annual Meeting; July 17, 2024; Stockholm, Sweden. https://medically.roche.com/content/dam/pdmahub/restricted/ophthalmology/asrs-2024/ASRS-2024-presentation-khanani-four-year-outcomes-of-faricimab-in-DME.pdf&ved=2ahUKEwjNjPC2o7yIAxWAlIkEHVUvA9gQFnoECA0QAQ&usg=AOvVaw2ZsjzwBiIyxYBVLqHtvM1x
Khanani AM, Campochiaro PA, Graff JM, et al. Continuous ranibizumab via port delivery system vs monthly ranibizumab for treatment of diabetic macular edema: The PAGODA randomized clinical trial. JAMA Ophthalmol. Published online March 6, 2025. https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2830898
Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254.
Li M, He J, Vanderbeek BL, Ying GS. Racial and ethnic disparities at enrollment in DRCRnet clinical trials for diabetic macular edema. Am J Ophthalmol. 2025;273:231-239. https://www.ajo.com/article/S0002-9394(25)00095-9/fulltext
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
Singh RP. Management of High-risk Non-proliferative Diabetic Retinopathy Without Diabetic Macular Edema: Results From PANORAMA. Presented at AAO 2019.
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.
The Diabetic Retinopathy Study Research Group. Preliminary Report on Effects of Photocoagulation Therapy. Am J Ophthalmol. 1976;81:383-396.
Wells JA, Keane P, Holekamp KP, et al. Comparison of the relative Effectiveness of Faricimab▼ for the treatment of diabetic macular edema (DME). Presented at the 48th Annual Macula-Society Meeting; February 12-15, 2025; Charlotte Harbor, FL. https://medically.roche.com/global/en/ophthalmology/macula-society-2025/medical-material/Macula-Society-2025-presentation-wells-comparative-efficacy-of-faricimab-pdf.html
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.
All URLs accessed April 11, 2025
