Clinical Studies:

GATHER2

Summarized by Ryan Sie, B.S. (Retina Associates of Orange County) and Mrinali Gupta, M.D. (Retina Associates of Orange County)

Citation: Jaffe, G.J., Westby, K., Csaky, K.G., et al., C5 inhibitor avacincaptad pegol for geographic atrophy due to age-related macular degeneration. Ophthalmology 2021; 128:576-586.

Key Points

  • GATHER2 was an international, prospective, randomized, double-masked, sham-controlled phase 2/3 pivotal clinical trial that evaluated avacincaptad pegol 2 mg or avacincaptad pegol 4 mg for treatment of geographic atrophy (GA) vs sham
  • There was a decrease in GA lesion growth in both avacincaptad pegol groups vs sham
  • Both avacincaptad pegol groups were well-tolerated in the elderly patient population, with no reported ocular adverse events (AEs) or serious adverse events (SAEs)
  • Objective

    To evaluate the safety and efficacy of avacincaptad pegol, a complement C5 inhibitor, for treatment of GA

  • STUDY DESIGN

    International, prospective, randomized, double-masked, sham-controlled phase 2/3 pivotal clinical trial

STUDY SUBJECTS




RANDOMIZATION SCHEME AND INTERVENTIONS




Because avacincaptad pegol 2 mg and corresponding sham arm were present in both parts 1 and 2 of the trial, eyes randomized in part 1 were combined with the eyes randomized in part 2, analyzed including a regression factor by part


Primary Endpoint


Secondary Endpoint


Results


Study Population


Primary Outcome: Square root transformation of the GA lesion area from baseline to month 12


Secondary Outcomes:


Safety Analyses:


Conclusions: