Clinical Studies:

Filly

Summarized by Ryan Sie, BS (Retina Associates of Orange County) and Mrinali Gupta, MD (Retina Associates of Orange County)

Citation: Liao, D.S., Grossi, F.V., El Mehdi, D., et al., Complement C3 inhibitor pegcetacoplan for geographic atrophy secondary to age-related macular degeneration. Ophthalmology 2019; 127(2): 186-195.

Key Points

  • FILLY was a prospective, multicenter, randomized, sham-controlled phase 2 study that evaluated pegcetacoplan 15 mg monthly or every other month (EOM) for treatment of geographic atrophy (GA) vs sham
  • There was a decrease in GA lesion growth in both pegcetacoplan groups vs sham
  • The safety profile was similar to that observed in studies of other intravitreally administered drugs with the exception of the development of exudative age-related macular degeneration (AMD)
  • Objective

    To evaluate the safety and efficacy of pegcetacoplan, a complement C3 inhibitor, for treatment of GA

  • STUDY DESIGN

    Prospective, multicenter, randomized, sham-controlled phase 2 study

Clinical Trial Guide Video Thumb Watch VBS members discuss this study on New Retina Radio Journal Club

With Aleksandra Rachitskaya, MD; Emmanuel Chang, MD, PhD; Michael Klufas, MD; and Dmitra Skondra, MD

STUDY SUBJECTS


RANDOMIZATION SCHEME AND INTERVENTIONS

Randomized 2:2:1:1 to


Primary Endpoint


Secondary Endpoint


Primary Safety Endpoint


Genetic Analysis

Results

Study population:


Primary Outcome: Change from baseline to month 12 in the square root of the GA lesion area


Secondary Outcomes


Rescue Treatment


Safety


Conclusions