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

OBJECTIVE

To examine the impacts of time since diagnosis of macular edema after central or branch retinal vein occlusion (MEfCRVO or MEfBRVO) to the first intravitreal aflibercept 2 mg injection (IAI) and baseline best-corrected visual acuity (BCVA) on visual and anatomic outcomes and 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, followed by as needed from week 24 to 100 (COPERNICUS) or 76 (GALILEO), and patients with MEfBRVO from VIBRANT treated with IAI every 4 weeks, followed by every 8 weeks from week 24 to 52.

METHODS

Patients were grouped by time from initial MEfCRVO/MEfBRVO diagnosis to first IAI, <1, 1 to 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 to ≤58; T3, >58 letters (COPERNICUS); T1, ≤47; T2, >47 to ≤65; T3, >65 letters (GALILEO); and T1, ≤55; T2, >55 to ≤64; and T3, >64 letters (VIBRANT).

RESULTS

In COPERNICUS, 113 patients initiated IAI at <1 (n = 44; 38.9%), 1 to 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% confidence interval] difference between <1- and >3-month groups: +7.9 [1.7-14.1]; P = 0.01). Central subfield thickness (CST) 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). CST at week 100 was similar across T1 to T3 (243.8-291.5 μm, respectively). Outcomes were similar in GALILEO and VIBRANT.

CONCLUSION

In MEfCRVO/MEfBRVO, a 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.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.