Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Astellas

Status and phase: Active, not recruiting; Phase 3

Conditions: Age-Related Macular Degeneration; Geographic Atrophy

Treatments: Drug: avacincaptad pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT05536297

ISEE2009

2022-002860-59 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 278 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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• Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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278 participants in 1 patient group

avacincaptad pegol

Experimental group

Description:

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

Treatment:

Drug: avacincaptad pegol