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Completed

NCT Number: NCT05536297

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 23 visit on study treatment (either avacincaptad pegol or Sham).

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Key information

Conditions

Geographic Atrophy Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oftalmólogos Especialistas, Rosario, Sante Fe, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment.
  • Patient must provide new written informed consent for this OLE trial prior to participation.
  • Patient must have the ability to return for all trial visits for the duration of the 18-month trial.

Exclusion criteria

  • Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).
  • Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.
  • Patient did not enroll into this OLE trial within the 90 day enrollment period.
  • Patient who is pregnant or nursing.

Treatment and study plan

Avacincaptad Pegol

Drug

Intravitreal Injection

Other names: Zimura (previous name), ARC1905, Izervay

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 18 months

    An AE is defined as any untoward medical occurrence in a participant including unfavorable and unintended signs, symptoms or disease temporally associated with the use of a medicinal product and which does not necessarily have to have a causal relationship to this treatment.

    AEs include illnesses with onset during the trial, or exacerbations of pre-existing illnesses. Exacerbation of pre-existing illness is defined as a significant increase in the severity of the illness as compared to the start of the trial and was considered when a participant requires new or additional treatment for that illness. Lack of or insufficient clinical response or efficacy was not recorded as an AE.

Secondary outcomes

  1. Number of Participants With Anti-drug Antibody (ADA)

    Time frame: Up to 18 months

    Number of participants with ADA = Post-baseline positive (in Baseline negative group) + treatment-boosted ADA positive (in Baseline positive group) / participants with a Baseline and at least one post-baseline sample.

    For participants whose ADA status is positive at Baseline, a post-baseline titer value that is >= 4 times higher than the Baseline is considered treatment-boosted ADA.

  2. Plasma Concentrations of ACP

    Time frame: Months 1, 2, 4, 7, 13, and 18

    Concentrations below the lower limit of quantification (3.36 ng/mL) are set to zero for calculation of summary statistics.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Registry information

Official study title

An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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