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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.

Publication ,  Journal Article
Glassman, AR; Beaulieu, WT; Maguire, MG; Antoszyk, AN; Chow, CC; Elman, MJ; Jampol, LM; Salehi-Had, H; Sun, JK; DRCR Retina Network,
Published in: JAMA Ophthalmol
July 1, 2021

IMPORTANCE: 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. OBJECTIVE: To compare exploratory outcomes between treatment groups that may affect treatment choices for patients with vitreous hemorrhage due to PDR. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOMES AND MEASURES: Visual acuity area under the curve (adjusted for baseline VA) and clearance of vitreous hemorrhage. RESULTS: 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). CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02858076.

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Published In

JAMA Ophthalmol

DOI

EISSN

2168-6173

Publication Date

July 1, 2021

Volume

139

Issue

7

Start / End Page

725 / 733

Location

United States

Related Subject Headings

  • Vitreous Hemorrhage
  • Vitrectomy
  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Ranibizumab
  • Middle Aged
  • Male
 

Citation

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Chicago
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Glassman, A. R., Beaulieu, W. T., Maguire, M. G., Antoszyk, A. N., Chow, C. C., Elman, M. J., … DRCR Retina Network, . (2021). 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. JAMA Ophthalmol, 139(7), 725–733. https://doi.org/10.1001/jamaophthalmol.2021.1110
Glassman, Adam R., Wesley T. Beaulieu, Maureen G. Maguire, Andrew N. Antoszyk, Clement C. Chow, Michael J. Elman, Lee M. Jampol, Hani Salehi-Had, Jennifer K. Sun, and Jennifer K. DRCR Retina Network. “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.JAMA Ophthalmol 139, no. 7 (July 1, 2021): 725–33. https://doi.org/10.1001/jamaophthalmol.2021.1110.
Glassman, Adam R., et al. “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.JAMA Ophthalmol, vol. 139, no. 7, July 2021, pp. 725–33. Pubmed, doi:10.1001/jamaophthalmol.2021.1110.
Glassman AR, Beaulieu WT, Maguire MG, Antoszyk AN, Chow CC, Elman MJ, Jampol LM, Salehi-Had H, Sun JK, DRCR Retina Network. 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. JAMA Ophthalmol. 2021 Jul 1;139(7):725–733.

Published In

JAMA Ophthalmol

DOI

EISSN

2168-6173

Publication Date

July 1, 2021

Volume

139

Issue

7

Start / End Page

725 / 733

Location

United States

Related Subject Headings

  • Vitreous Hemorrhage
  • Vitrectomy
  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Ranibizumab
  • Middle Aged
  • Male