Avacincaptad Pegol for Geographic Atrophy

Recruiting in Palo Alto (17 mi)

+118 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Astellas Pharma Global Development, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for patients aged 50 or older with a condition called Geographic Atrophy, who completed the GATHER2 study. They must be able to attend all visits over an 18-month period and not have dropped out of the previous study due to side effects.

Inclusion Criteria

Patient must have the ability to return for all trial visits for the duration of the 18-month trial

I am 50 or older with GA and finished the GATHER2 study up to Month 24.

Patient must provide new written informed consent for this OLE trial prior to participation

Exclusion Criteria

Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham)

Patient did not enroll into this OLE trial within the 90 day enrollment period

I have never been removed from the ISEE2008 study due to side effects.

+1 more

Participant Groups

The trial involves monthly injections of Avacincaptad pegol (2 mg) directly into the eye. It's designed for those who've already received this treatment in a prior study and aims to further evaluate its long-term effects.

1Treatment groups

Experimental Treatment

Group I: avacincaptad pegolExperimental Treatment1 Intervention

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