Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Phase 3

Completed

• Conditions: Geographic Atrophy; Age-Related Macular Degeneration
• Interventions: Drug: avacincaptad pegol

• Registration Number: NCT05536297
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

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 24 visit on study treatment (either avacincaptad pegol or Sham).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Study Start: 2022-09-26
• Primary Completion: 2025-04-10
• Study Completion: 2025-04-10
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-29
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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• Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
avacincaptad pegol	avacincaptad pegol	Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events (AEs)	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 should be considered when a participant requires new or additional treatment for that illness.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration	Up to 18 Months	Concentration will be recorded from the PK plasma samples collected.
Number of participants with Anti-Drug Antibody (ADA) status	Up to 18 Months	ADA will be recorded from the serum samples collected. Overall ADA status will be reported: ADA-negative, ADA positive, ADA-inconclusive and unevaluable sample.

Trial Locations

Locations (117)

Retinal Diagnostic Center; 🇺🇸 Campbell, California, United States

Eye Medical Center of Fresno; 🇺🇸 Fresno, California, United States

Retina Consultants of Orange County; 🇺🇸 Fullerton, California, United States

Jacobs Retina Center at The Shiley Eye Institute USCD; 🇺🇸 La Jolla, California, United States

Jules Stein Eye Institute David Geffen School of Medicine; 🇺🇸 Los Angeles, California, United States

Doheny Eye Center, UCLA; 🇺🇸 Pasadena, California, United States

Retina Consultants of Southern California; 🇺🇸 Redlands, California, United States

Orange County Retinal Med Group; 🇺🇸 Santa Ana, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Retina Consultants of Southern CO; 🇺🇸 Colorado Springs, Colorado, United States

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