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A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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Trial Profile

A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 26 May 2025

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At a glance

  • Drugs Avacincaptad pegol (Primary)
  • Indications Dry age-related macular degeneration; Dry macular degeneration
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms GATHER1
  • Sponsors IVERIC bio

Most Recent Events

  • 01 May 2025 According to an Astellas Pharma media release, data from the GATHER studies will be presented at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO), May 4-8, Salt Lake City, Utah, and Retina World Congress (RWC), May 8-11, Fort Lauderdale, Florida.
  • 05 Feb 2025 According to an Astellas Pharma media release, based on the GATHER1 and GATHER2 clinical trials, announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for Conditional Approval of avacincaptad pegol intravitreal solution (ACP), a synthetic aptamer that inhibits the complement C5 protein, for the treatment of GA secondary to AMD. If approved, ACP has the potential to become the first and only GA treatment available in Japan.
  • 17 Aug 2023 According to an IVERIC bio media release, based on the GATHER1 and GATHER2 clinical trials, the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The CHMP of the EMA will start its review of the MAA under the centralized licensing procedure for all 27 member state of the European Union (EU).

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