Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Summary

The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy. Secondary objectives include: * Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP. * Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP. * Comparing safety outcomes between treatment groups. * Comparing associated treatment and follow-up exam costs between treatment groups.

Timeline

Start

2012-03

Primary completion

2015-01

Completion

2018-02-05

Publications

• Background Gross JG, Glassman AR. A Novel Treatment for Proliferative Diabetic Retinopathy: Anti-Vascular Endothelial Growth Factor Therapy. JAMA Ophthalmol. 2016 Jan;134(1):13-4. doi: 10.1001/jamaophthalmol.2015.5079. No abstract available.
• Background Gross JG, Glassman AR. Panretinal Photocoagulation vs Anti-Vascular Endothelial Growth Factor for Proliferative Diabetic Retinopathy-Reply. JAMA Ophthalmol. 2016 Jun 1;134(6):716. doi: 10.1001/jamaophthalmol.2016.0703. No abstract available.
• Background Beaulieu WT, Bressler NM, Melia M, Owsley C, Mein CE, Gross JG, Jampol LM, Glassman AR; Diabetic Retinopathy Clinical Research Network. Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Patient-Centered Outcomes From a Randomized Clinical Trial. Am J Ophthalmol. 2016 Oct;170:206-213. doi: 10.1016/j.ajo.2016.08.008. Epub 2016 Aug 12.
• Background Bressler SB, Beaulieu WT, Glassman AR, Gross JG, Jampol LM, Melia M, Peters MA, Rauser ME; Diabetic Retinopathy Clinical Research Network. Factors Associated with Worsening Proliferative Diabetic Retinopathy in Eyes Treated with Panretinal Photocoagulation or Ranibizumab. Ophthalmology. 2017 Apr;124(4):431-439. doi: 10.1016/j.ophtha.2016.12.005. Epub 2017 Feb 1.
• Background Hutton DW, Stein JD, Bressler NM, Jampol LM, Browning D, Glassman AR; Diabetic Retinopathy Clinical Research Network. Cost-effectiveness of Intravitreous Ranibizumab Compared With Panretinal Photocoagulation for Proliferative Diabetic Retinopathy: Secondary Analysis From a Diabetic Retinopathy Clinical Research Network Randomized Clinical Trial. JAMA Ophthalmol. 2017 Jun 1;135(6):576-584. doi: 10.1001/jamaophthalmol.2017.0837.
• Background Gross JG, Glassman AR, Klein MJ, Jampol LM, Ferris FL 3rd, Bressler NM, Beck RW. Interim Safety Data Comparing Ranibizumab With Panretinal Photocoagulation Among Participants With Proliferative Diabetic Retinopathy. JAMA Ophthalmol. 2017 Jun 1;135(6):672-673. doi: 10.1001/jamaophthalmol.2017.0969.
• Background Jampol LM, Odia I, Glassman AR, Baker CW, Bhorade AM, Han DP, Jaffe GJ, Melia M, Bressler NM, Tanna AP; Diabetic Retinopathy Clinical Research Network. PANRETINAL PHOTOCOAGULATION VERSUS RANIBIZUMAB FOR PROLIFERATIVE DIABETIC RETINOPATHY: Comparison of Peripapillary Retinal Nerve Fiber Layer Thickness in a Randomized Clinical Trial. Retina. 2019 Jan;39(1):69-78. doi: 10.1097/IAE.0000000000001909.
• Background Bressler SB, Beaulieu WT, Glassman AR, Gross JG, Melia M, Chen E, Pavlica MR, Jampol LM; Diabetic Retinopathy Clinical Research Network. Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Factors Associated with Vision and Edema Outcomes. Ophthalmology. 2018 Nov;125(11):1776-1783. doi: 10.1016/j.ophtha.2018.04.039. Epub 2018 Jul 3.
• Background Gross JG, Glassman AR, Liu D, Sun JK, Antoszyk AN, Baker CW, Bressler NM, Elman MJ, Ferris FL 3rd, Gardner TW, Jampol LM, Martin DF, Melia M, Stockdale CR, Beck RW; Diabetic Retinopathy Clinical Research Network. Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Oct 1;136(10):1138-1148. doi: 10.1001/jamaophthalmol.2018.3255.
• Background Sun JK, Glassman AR, Beaulieu WT, Stockdale CR, Bressler NM, Flaxel C, Gross JG, Shami M, Jampol LM; Diabetic Retinopathy Clinical Research Network. Rationale and Application of the Protocol S Anti-Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy. Ophthalmology. 2019 Jan;126(1):87-95. doi: 10.1016/j.ophtha.2018.08.001. Epub 2018 Aug 7.
• Background Bressler SB, Beaulieu WT, Glassman AR, Gross JG, Melia M, Chen E, Pavlica MR, Jampol LM; Diabetic Retinopathy Clinical Research Network. PHOTOCOAGULATION VERSUS RANIBIZUMAB FOR PROLIFERATIVE DIABETIC RETINOPATHY: Should Baseline Characteristics Affect Choice of Treatment? Retina. 2019 Sep;39(9):1646-1654. doi: 10.1097/IAE.0000000000002377.
• Background Glassman AR, Beaulieu WT, Stockdale CR, Beck RW, Bressler NM, Labriola LT, Melia M, Oliver K, Sun JK. Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial. Clin Trials. 2020 Apr;17(2):195-201. doi: 10.1177/1740774519894229. Epub 2020 Jan 27.
• Background Maguire MG, Liu D, Glassman AR, Jampol LM, Johnson CA, Baker CW, Bressler NM, Gardner TW, Pieramici D, Stockdale CR, Sun JK; DRCR Retina Network. Visual Field Changes Over 5 Years in Patients Treated With Panretinal Photocoagulation or Ranibizumab for Proliferative Diabetic Retinopathy. JAMA Ophthalmol. 2020 Mar 1;138(3):285-293. doi: 10.1001/jamaophthalmol.2019.5939.
• Background Hutton DW, Stein JD, Glassman AR, Bressler NM, Jampol LM, Sun JK; DRCR Retina Network. Five-Year Cost-effectiveness of Intravitreous Ranibizumab Therapy vs Panretinal Photocoagulation for Treating Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2019 Dec 1;137(12):1424-1432. doi: 10.1001/jamaophthalmol.2019.4284.
• Results Writing Committee for the Diabetic Retinopathy Clinical Research Network; Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL 3rd, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2137-2146. doi: 10.1001/jama.2015.15217.
• Talcott KE, Valentim CCS, Hill L, Stoilov I, Singh RP. Baseline Diabetic Retinopathy Severity and Time to Diabetic Macular Edema Resolution with Ranibizumab Treatment: A Meta-Analysis. Ophthalmol Retina. 2023 Jul;7(7):605-611. doi: 10.1016/j.oret.2023.02.003. Epub 2023 Feb 10.
• Maguire MG, Liu D, Bressler SB, Friedman SM, Melia M, Stockdale CR, Glassman AR, Sun JK; DRCR Retina Network. Lapses in Care Among Patients Assigned to Ranibizumab for Proliferative Diabetic Retinopathy: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Dec 1;139(12):1266-1273. doi: 10.1001/jamaophthalmol.2021.4103.

Drugs

Indications