Impact of Pegcetacoplan on Progression of Nascent Atrophy in Age-related Macular Degeneration (AMD)

Abstract

Purpose : To evaluate the potential impact of pegcetacoplan on nascent geographic atrophy (GA) lesions by analyzing their progression in patients who received either intravitreal pegcetacoplan monthly (PM) or sham treatment (S) in the phase 2 multicenter, randomized, single-masked, sham-controlled FILLY study through a post-hoc analysis.

Methods : Patients from the PM (n=42) and S (n=69) arms of the FILLY study who did not develop exudative AMD and completed the month 12 study visit were included in this analysis. The evaluation was based on examination by masked readers of optical coherence tomography (OCT) scans outside a perimeter of 500 microns from the GA border according to the Classification of Atrophy Meetings (CAM) guidelines. The primary outcome measures were a) progression from large drusen to incomplete/complete retinal pigment epithelium (RPE) and outer retina atrophy (iRORA and/or cRORA) and b) progression from iRORA to cRORA at baseline, 6 months, and 12 months.

Results : At baseline, large drusen were observed in 81% (33/41) of patients in the PM group and 74% (49/66) of patients in the S group; iRORA was present in 46% (19/41) and 55% (36/66) of patients in the PM and S groups, respectively. At 12 months, progression from large drusen to iRORA/cRORA occurred in 22.6% (7/31) and 33.3% (15/45) of the PM and S groups, respectively (p=0.31). At the lesion level, these rates were 9.1% (11/121) and 11.9% (21/177) in the PM and S groups, respectively. Progression from iRORA to cRORA was 50.0% (9/18) and 81.8% (27/33) in the PM and S groups, respectively (p=0.02), indicating a lower rate of progression from iRORA to cRORA (39% reduction) in pegcetacoplan-treated eyes. At the lesion level, these rates were 35.5% (11/31) and 64.3% (45/70) in the PM and S groups, respectively.

Conclusions : Eyes receiving monthly intravitreal pegcetacoplan had lower rates of progression from nascent GA to GA compared to sham-treated controls, suggesting a potential role for pegcetacoplan earlier in the course of GA.

This is a 2021 ARVO Annual Meeting abstract.