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  • Intravitreal pegcetacoplan may be linked with increased incidence of exudative AMD

    Retina/Vitreous

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    Review of: Characterizing new-onset exudation in the randomized phase 2 FILLY trial of complement inhibitor pegcetacoplan for geographic atrophy

    Wykoff C, Rosenfeld P, Waheed N, et al. Ophthalmology, September 2021

    A post hoc analysis of the phase 2 prospective, randomized, sham injection–controlled FILLY trial of pegcetacoplan for the treatment of geographic atrophy (GA) focused on participants who developed new-onset, investigator-determined exudative age-related macular degeneration (eAMD) during the trial.

    Study design

    A total of 246 patients aged ≥50 years were randomized to receive sham injection or pegcetacoplan 15-mg injection once monthly or every other month for 12 months, followed by 6 months of follow-up. Twenty-six patients across all 3 treatment groups developed new-onset eAMD; the mean time to diagnosis of eAMD was 256 days.

    Outcomes

    The development of eAMD did not have a significant negative impact on visual acuity, and all patients responded positively to anti-VEGF therapy. Overall, among the patients who developed eAMD, 69% had a baseline history of eAMD in the fellow eye and 73% had a double-layer sign on OCT in the study eye; these were greater percentages than seen in the non-eAMD population.

    Limitations

    The original FILLY trial was focused on GA, and thus was not powered to look at differences in development of eAMD. This analysis also included only patients with investigator-diagnosed eAMD that was not necessarily confirmed by the central reading center or with OCT.

    Clinical significance

    Intravitreal pegcetacolplan appears associated with an unexpected dose-dependent increased incidence of eAMD. If intravitreal pegcetacoplan is approved for the treatment of GA, it will be important to continue to monitor eyes receiving that treatment for potential development of eAMD.