Clinical Studies:
DRCR Protocol AB
Citations:
Antoszyk AN, Glassman AR, Beaulieu WT, Jampol LM, Jhaveri CD, Punjabi OS, Salehi-Had H, Wells JA 3rd, Maguire MG, Stockdale CR, Martin DF, Sun JK; DRCR Retina Network. Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2020 Dec 15;324(23):2383-2395.
Key Points
- Compared ininitial treatment with intravitreal aflibercept versus vitrectomy with panretinal photocoagulation with vitreous hemorrhage secondary to proliferative diabetic retinopathy
- 205 patients at 39 DRCR sites
- No significant difference in primary outcome of mean visual acuity letter score over 24 weeks, though vitrectomy eyes had earlier improvement in vision and the authors note the study may have been underpowered to detect the benefit of early vitrectomy
- Over 2 years, 33% of eyes assigned to aflibercept received vitrectomy, 32% of eyes assigned to vitrectomy received subsequent aflibercept
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Objective
To compare initial treatment with intravitreal aflibercept versus pars plana vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy
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STUDY DESIGN
Randomized clinical trial at 39 DRCR sites in US and Canada
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Duration
24 weeks primary study, planned secondary endpoints out to 2 years
Watch VBS members discuss this study on New Retina Radio Journal Club
With Aleksandra Rachitskaya, MD; Mrinali Gupta, MD; Eric Nudleman, MD, PhD; and Aris Thanos, MD
STUDY SUBJECTS
- Adults (age >18)
- Diagnosis of diabetes mellitus (either Type 1 or Type 2)
- Able to undergo vitrectomy within 2 weeks of enrollment, but vitrectomy not required within 4 months of enrollment
- Vitreous hemorrhage, visually significant, deemed to be due to PDR
- BCVA between 20/32 and LP
Major inclusion criteria:
- Known DME
- TRD involving or threatening the macula
- NVG (iris or angle neovascularization does not preclude)
- History of prior vitrectomy
Major exclusion criteria:
Of note, prior treatment of PDR with injections or PRP did not preclude enrollment
RANDOMIZATION SCHEME AND INTERVENTIONS
Randomized 1:1 (1 eye per patient) to
(a) Intravitreal 2mg aflibercept at enrollment then q 4 weeks for 4 months
(b) Prompt vitrectomy with panretinal photocoagulation
Both groups could receive rescue PPV or aflibercept during the follow-up based on specific criteria
Results
Study population
- 205 subjects randomized, 100 aflibercept, 105 vitrectomy
- 24 weeks: 97 aflibercept, 98 vitrectomy
- 24 months: 90 aflibercept, 87 vitrectomy
Visual acuity end-points
- Mean visual acuity letter score over 24 weeks: 59.3 aflibercept group, 63.0 vitrectomy group, no significant difference but trend favoring vitrectomy group (*Authors note perhaps underpowered to deem this significant). Authors also note more rapid improvement in visual acuity in vitrectomy group
- Mean visual acuity letter score at two years: 73.7 aflibercept group, 71.0 vitrectomy group, no significant difference.
Recurrent Vitreous Hemorrhage
- Recurrent Vitreous hemorrhage up to 49% in aflibercept group compared with 15% vitrectomy group (significantly different)
Exploratory Outcome- DME
- At 24 weeks significantly more DME in vitrectomy group compared with aflibercept group (31% versus 8%)
Adverse events
- Endophthalmitis in 1 aflibercept, 2 vitrectomy
- New or worsened rhegmatogenous retinal detachment in 4% aflibercept, 5% vitrectomy
- Cataract extraction in 49% of aflibercept group and 44% of the vitrectomy group
CONCLUSIONS
- There was no significant difference in primary outcome of mean visual acuity letter score at 24 weeks following initial treatment with intravitreal aflibercept compared with vitrectomy with panretinal photocoagulation (however, the authors note the study may have been underpowered to detect the benefit of early vitrectomy).