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- Title
Visual Acuity, Vitreous Hemorrhage, and Other Ocular Outcomes After Vitrectomy vs Aflibercept for Vitreous Hemorrhage Due to Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.
- Authors
Glassman, Adam R.; Beaulieu, Wesley T.; Maguire, Maureen G.; Antoszyk, Andrew N.; Chow, Clement C.; Elman, Michael J.; Jampol, Lee M.; Salehi-Had, Hani; Sun, Jennifer K.; DRCR Retina Network
- Abstract
<bold>Importance: </bold>Although there were no differences in mean visual acuity (VA) over 24 weeks after vitrectomy with panretinal photocoagulation (PRP) vs aflibercept in a randomized clinical trial among eyes with vitreous hemorrhage due to proliferative diabetic retinopathy (PDR), post hoc analyses may influence treatment choices.<bold>Objective: </bold>To compare exploratory outcomes between treatment groups that may affect treatment choices for patients with vitreous hemorrhage due to PDR.<bold>Design, Setting, and Participants: </bold>This post hoc analysis of a randomized clinical trial conducted at 39 DRCR Retina Network sites included adults with vision loss due to PDR-related vitreous hemorrhage for whom vitrectomy was considered. Data were collected from November 2016 to January 2020.<bold>Interventions: </bold>Random assignment to 4 monthly injections of aflibercept vs vitrectomy with PRP. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol-specific criteria.<bold>Main Outcomes and Measures: </bold>Visual acuity area under the curve (adjusted for baseline VA) and clearance of vitreous hemorrhage.<bold>Results: </bold>A total of 205 eyes were included in the analysis (115 male [56%] and 90 [44%] female participants; mean [SD] age, 57 [11] years). Among 89 eyes with a baseline VA of 20/32 to 20/160 (47 receiving aflibercept, including 4 [9%] that had undergone vitrectomy; 42 undergoing vitrectomy, including 3 [7%] that had received aflibercept), the adjusted mean difference in VA letter score over 24 weeks between the aflibercept and vitrectomy groups was -4.3 (95% CI, -10.6 to 1.9) compared with -16.7 (95% CI, -24.4 to -9.1) among 59 eyes with baseline VA worse than 20/800 (P = .02 for interaction; 26 in the aflibercept group, including 6 [23%] that had undergone vitrectomy; 33 in the vitrectomy group, including 8 [24%] that had received aflibercept). In the full cohort, the median time to clearance of the initial vitreous hemorrhage was 36 (interquartile range [IQR], 24-52) weeks in the aflibercept group vs 4 (IQR, 4-4) weeks in the vitrectomy group (difference, 32 [95% CI, 20-32] weeks; P < .001).<bold>Conclusions and Relevance: </bold>Both initial aflibercept and vitrectomy with PRP are viable treatment approaches for PDR-related vitreous hemorrhage. Although this study did not find a significant difference between groups in the primary outcome of mean VA over 24 weeks of follow-up, eyes receiving initial vitrectomy with PRP had faster recovery of vision over 24 weeks when baseline VA was worse than 20/800 and faster vitreous hemorrhage clearance. Approximately one-third of the eyes in each group received the alternative treatment (aflibercept or vitrectomy with PRP). These factors may influence treatment decisions for patients initiating therapy for PDR-related vitreous hemorrhage.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT02858076.
- Subjects
RESEARCH; INJECTIONS; NEOVASCULARIZATION inhibitors; RESEARCH methodology; DIABETES; EYE hemorrhage; CELL receptors; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; RANDOMIZED controlled trials; VISUAL acuity; DIABETIC retinopathy; VASCULAR endothelial growth factors; RECOMBINANT proteins; DISEASE complications
- Publication
JAMA Ophthalmology, 2021, Vol 139, Issue 7, p725
- ISSN
2168-6165
- Publication type
journal article
- DOI
10.1001/jamaophthalmol.2021.1110