skip to main content
Language:
Search Limited to: Search Limited to: Resource type Show Results with: Show Results with: Search type Index

Effect of Intravitreous Anti–Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial

Archives of ophthalmology (1960), 2021-07, Vol.139 (7), p.701 [Peer Reviewed Journal]

Copyright American Medical Association Jul 2021 ;ISSN: 2168-6165 ;EISSN: 1538-3601 ;DOI: 10.1001/jamaophthalmol.2021.0606

Full text available

  • Title:
    Effect of Intravitreous Anti–Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial
  • Author: Maturi, Raj K ; Glassman, Adam R ; Josic, Kristin ; Antoszyk, Andrew N ; Blodi, Barbara A ; Jampol, Lee M ; Marcus, Dennis M ; Martin, Daniel F ; Melia, Michele ; Salehi-Had, Hani ; Stockdale, Cynthia R ; Punjabi, Omar S ; Sun, Jennifer K
  • Subjects: Acuity ; Clinical trials ; Diabetes ; Diabetes mellitus ; Diabetic retinopathy ; Edema ; Eye ; Retina ; Retinopathy ; Vascular endothelial growth factor ; Vision
  • Is Part Of: Archives of ophthalmology (1960), 2021-07, Vol.139 (7), p.701
  • Description: Importance The role of anti–vascular endothelial growth factor injections for the management of nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) has not been clearly established. Objective To determine the efficacy of intravitreous aflibercept injections compared with sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR. Design, Setting, and Participants Data for this study were collected between January 15, 2016, and May 28, 2020, from the ongoing DRCR Retina Network Protocol W randomized clinical trial, conducted at 64 US and Canadian sites among 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study severity level, 43-53), without CI-DME. Analyses followed the intent-to-treat principle. Interventions Eyes were randomly assigned to 2.0 mg of aflibercept injections (n = 200) or sham (n = 199) given at baseline; 1, 2, and 4 months; and every 4 months through 2 years. Between 2 and 4 years, treatment was deferred if the eye had mild NPDR or better. Aflibercept was administered in both groups if CI-DME with vision loss (≥10 letters at 1 visit or 5-9 letters at 2 consecutive visits) or high-risk proliferative diabetic retinopathy (PDR) developed. Main Outcomes and Measures Development of CI-DME with vision loss or PDR through May 2020, when the last 2-year visit was completed. Results Among the 328 participants (57.6% men [230 of 399 eyes]; mean [SD] age, 56 [11] years), the 2-year cumulative probability of developing CI-DME with vision loss or PDR was 16.3% with aflibercept vs 43.5% with sham. The overall hazard ratio for either outcome was 0.32 (97.5% CI, 0.21-0.50; P < .001), favoring aflibercept. The 2-year cumulative probability of developing PDR was 13.5% in the aflibercept group vs 33.2% in the sham group, and the 2-year cumulative probability of developing CI-DME with vision loss was 4.1% in the aflibercept group vs 14.8% in the sham group. The mean (SD) change in visual acuity from baseline to 2 years was −0.9 (5.8) letters with aflibercept and −2.0 (6.1) letters with sham (adjusted mean difference, 0.5 letters [97.5% CI, −1.0 to 1.9 letters]; P = .47). Conclusions and Relevance In this randomized clinical trial, among eyes with moderate to severe NPDR, the proportion of eyes that developed PDR or vision-reducing CI-DME was lower with periodic aflibercept compared with sham treatment. However, through 2 years, preventive treatment did not confer visual acuity benefit compared with observation plus treatment with aflibercept only after development of PDR or vision-reducing CI-DME. The 4-year results will be important to assess longer-term visual acuity outcomes.
  • Publisher: Chicago: American Medical Association
  • Language: English
  • Identifier: ISSN: 2168-6165
    EISSN: 1538-3601
    DOI: 10.1001/jamaophthalmol.2021.0606
  • Source: Alma/SFX Local Collection
Back to results list
INSPIRE LIBRARY - TON DUC THANG UNIVERSITY (84-028) 37 755 057 Feedback
19 Nguyen Huu Tho St. Dist.7, HCM thuvien@tdtu.edu.vn

Copyright © 2017 INSPIRE LIBRARY - TON DUC THANG UNIVERSITY

Searching Remote Databases, Please Wait