Effects of Time From Diagnosis to Treatment and Baseline Vision on Retinal Vein Occlusion Outcomes in Aflibercept 2 mg Phase 3 Trials.

Abstract

Objective: To examine impacts of time since diagnosis of macular edema following central or branch retinal vein occlusion (MEfCRVO or MEfBRVO) to first intravitreal aflibercept 2 mg injection (IAI) and baseline best-corrected visual acuity (BCVA) on visual and anatomic outcomes, to inform treatment decisions and management of physician and patient expectations.

Design: Post hoc analysis of 3 clinical trials.

Participants: Patients with MEfCRVO from COPERNICUS and GALILEO treated with IAI every 4 weeks then as needed from Week 24 to 100 (COPERNICUS) or 76 (GALILEO) and patients with MEfBRVO from VIBRANT treated with IAI 2 mg every 4 weeks then every 8 weeks from Week 24 to 52.

Methods: Patients were grouped by time from initial MEfCRVO/MEfBRVO diagnosis to first IAI, < 1, 1-3, or > 3 months (COPERNICUS/GALILEO), and < 1 or ≥ 1 month (VIBRANT).

Main outcome measures: Impact of baseline BCVA was evaluated by tertiles: T1, ≤ 44; T2, > 44-≤ 58; T3, > 58 letters (COPERNICUS), T1, ≤ 47; T2, > 47-≤ 65; T3, > 65 letters (GALILEO), and T1, ≤ 55; T2, > 55-≤ 64; T3, > 64 letters (VIBRANT).

Results: In COPERNICUS, 113 patients initiated IAI at < 1 (n = 44; 38.9%), 1-3 (n = 33; 29.2%), or > 3 months (n = 36; 31.9%) post-diagnosis; mean BCVA gains from baseline at Week 24 were 19.8, 15.6, and 11.9 letters, respectively (mean [95% CI] difference between < 1-month and > 3-month groups: +7.9 [1.7, 14.1]; P = 0.01). Central retinal thickness (CRT) decrease from baseline at Week 24 across time-since-diagnosis subgroups was -466.6, -456.4, and -479.2 μm, respectively. Least squares mean BCVA gains from baseline at Week 100 were greater for baseline BCVA T1 versus T2/T3 (16.5 vs 8.9/5.9 letters) but final BCVA was lower (49.8 vs 60.9/71.2 letters, respectively). CRT at Week 100 was similar across T1-T3 (243.8-291.5 μm, respectively). Outcomes were similar in GALILEO and VIBRANT.

Conclusion: In MEfCRVO/MEfBRVO, longer time to IAI treatment initiation was followed by less visual improvement. Poor baseline BCVA was associated with greater visual improvement but worse final BCVA.