June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
A Randomized Trial of Intravitreous Anti-VEGF for Prevention of Vision Threatening Complications of Diabetic Retinopathy (Protocol W)
Author Affiliations & Notes
  • Raj K Maturi
    Midwest Eye Institute, Indianapolis, Indiana, United States
    Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Footnotes
    Commercial Relationships   Raj Maturi Allegro, Aiviva, Allergan, Allgenesis, Eli Lilly, Dutch Ophthalmic, Novartis, neurotech, Jaeb Center for Health Research, Code C (Consultant/Contractor), Allergan, Genentech, Ophthea, Kalvista, Samsung Bioepies, Graybug, Santen, Thromobgenics, Gyroscope, Gemini, Boehringer Ingelheim, Allegro, Senju, Ribomic, NGM biopharmaceuticals, Unity, Graybug, Clearside, Code F (Financial Support)
  • Footnotes
    Support  NIH Grant
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2812. doi:
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    • Get Citation

      Raj K Maturi; A Randomized Trial of Intravitreous Anti-VEGF for Prevention of Vision Threatening Complications of Diabetic Retinopathy (Protocol W). Invest. Ophthalmol. Vis. Sci. 2023;64(8):2812.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To determine if early aflibercept treatment in patients with non-proliferative diabetic
retinopathy (NPDR), good vision, and no center-involved DME (CI-DME) reduces
disease progression and improves long-term visual acuity (VA) compared with treatment only if disease
worsens.

Methods : Across 64 sites in the U.S. and Canada, 399 eyes (328 participants) with moderate to severe
NPDR were randomized to receive quarterly 2.0-mg aflibercept or sham injections for 4 years, with 3
initial monthly injections at baseline and the option to defer injections starting at year 2 if the eye
regressed to mild NPDR or better. Eyes that progressed to high-risk PDR
or developed CI-DME with vision loss initiated an anti-vascular endothelial growth factor (VEGF)
treatment regimen with aflibercept. Time to the development of PDR or CI-DME with vision loss,
treatment initiation, and change in VA were analyzed.

Results : In aflibercept (N = 200) vs sham (N = 199) study eyes, the 4-year cumulative probability of
developing PDR or CI-DME with vision loss was 34% vs. 57% [adjusted hazard ratio = 0.40 (97.5% CI:
0.28, 0.57; P<0.001)]. The probability of initiating anti-VEGF treatment for high-risk PDR for CI-DME
within 4 years in aflibercept vs. sham was 19% vs. 57% overall, 9% vs. 24% in eyes with baseline NPDR
level 43, 16% vs. 34% in level 47A, 18% vs. 39% in levels 47 B-D and 29% vs. 64% in level 53 (baseline
NPDR by treatment group interaction P = 0.94). The mean (sd) of VA change from
baseline to 4 years in aflibercept vs. sham was -2.7 (6.5) vs. -2.4 (5.8) letters [adjusted mean difference =
-0.5 letters (97.5% CI: -2.3 to 1.3, P=0.52] overall, -5.6 (7.9) vs. -3.4 (6.0) letters in eyes that initiated
anti-VEGF treatment for high-risk PDR or CI-DME and -2.0 (5.9) vs. -1.7 (5.5) letters in eyes that did not
(anti-VEGF treatment initiation by treatment group interaction P = 0.13).

Conclusions : At 4 years, treatment for NPDR with aflibercept vs. sham initiating treatment only after the
disease worsened resulted in statistically significant anatomic improvement but no improvement in
visual acuity. The differences between treatment groups did not significantly vary across baseline NPDR
severities or whether treatment for vision-threatening complications was initiated. Aflibercept as a
preventative strategy used in this trial may not be generally warranted for patients with NPDR without
CI-DME.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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