Abstract
Purpose :
Eyes with moderate to severe non-proliferative diabetic retinopathy (NPDR) are at high risk for disease progression and development of vision-threatening complications. The DRCR Retina Network Protocol W aimed to determine if aflibercept can prevent the development of proliferative diabetic retinopathy (PDR) and center-involved diabetic macular edema (CI-DME) over 2 years and if so, whether there is an associated visual benefit at 4 years.
Methods :
In this multi-center randomized clinical trial, eligible eyes had moderate to severe NPDR (ETDRS severity levels 43-53), without center-involved diabetic macular edema. Eyes were randomly assigned to intravitreal 2.0-mg aflibercept or sham injections performed at baseline, 1, 2, and 4 months and every 4 months through 2 years. Thereafter, through 4 years, treatment was deferred if the eye had no worse than mild NPDR. Aflibercept was provided in both groups if CI-DME with vision loss or high-risk PDR developed. Time to development of PDR or CI-DME with vision loss (primary outcome) were analyzed with marginal Cox regression models, and 2-year change in visual acuity was analyzed with a linear mixed model.
Results :
We enrolled 328 participants (mean age 56 years; mean HbA1c 8.8%; 42% female; 47% White, 30% Hispanic and 15% Black) with 399[KJ1] study eyes across 64 clinics in the U.S. and Canada[KJ2] . There were 200 eyes assigned to aflibercept and 199 eyes assigned to sham. At enrollment, 17% of study eyes had moderate NPDR (level 43), 32% had moderately severe NPDR (47A), 27% had moderately severe NPDR (level 47B-D), and 24% had severe NPDR (level 53). Mean baseline visual acuity was 87.6 [KJ3] letters and mean baseline central subfield thickness was 281 µm [KJ4] (Heidelberg Spectralis equivalent). All available data by the time the last participant completed the 2-year visit will be presented. Results have been analyzed and reviewed by the Data and Safety Monitoring Committee, but per National Eye Institute requirements for NIH-funded clinical trials, primary results cannot be made publicly available before publication. Publication is anticipated shortly before or at the time of presentation.
Conclusions :
Conclusions will follow from the results presented.
This is a 2021 ARVO Annual Meeting abstract.