Long-Term Efficacy of Intravitreal Aflibercept Injections for the Treatment of Non-Proliferative Diabetic Retinopathy among Subjects Completing the 2-Year PANORAMA Trial

Abstract

Purpose : PANORAMA was a phase 3 clinical trial in which subjects with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) were randomized to intravitreal aflibercept injection (IAI) or sham. At 2 years, more patients treated with IAI had reductions in the severity of their NPDR relative to sham. VOYAGE is a follow-up prospective study of the long-term efficacy and safety of IAI among subjects completing PANORAMA.

The purpose of the present analysis is to assess effects of PANORAMA randomization to IAI or sham on diabetic retinopathy (DR) severity among subjects being managed at physician discretion in routine clinical care during the period after completion of PANORAMA and before enrollment in VOYAGE (study interval).

Methods : Retrospective chart review of patient data assessing key clinical factors including visual acuity (VA), physician-reported DR severity score (DRSS), and treatment patterns with intravitreal anti-VEGF (IAV) therapy and panretinal photocoagulation (PRP).

Results : Forty-one patients enrolled in VOYAGE, 11 (26.8%) from the PANORAMA sham arm, 18 (43.9%) from the 8-week IAI arm, and 12 (29.3%) from the 16-week IAI arm. Twenty-one (51.2%) were male with a mean age of 59.3 years. The mean duration of the study interval was 33.7 months. During the study interval, 43.9% (18) received no ocular treatments. Among treated patients, 12.2% (5) received PRP monotherapy, 31.7% (13) received IAV only, and 12.2% (5) received combination PRP and IAV treatment.

Randomization to IAI treatment in PANORAMA did not correlate with change in VA or DRSS during the study interval (p=0.41 and p=0.57, respectively). Similarly, subjects’ PANORAMA treatment assignment did not correlate with likelihood for treatment during the study interval (p=0.79). The duration of the study interval did not correlate with change in VA (p=0.6) nor change in DRSS (p=0.3).

Conclusions : No correlation was found between PANORAMA treatment assignment and change in VA or DRSS during the study interval, encompassing the time from PANORAMA exit to VOYAGE enrollment. Furthermore, PANORAMA assignment did not correlate with treatment during the study interval. Further analyses are warranted to more completely understand the role of IVA in the management of NPDR.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.