Avacincaptad Pegol for Geographic Atrophy

Recruiting at 118 trial locations

Overseen By Yordak Salermo

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Astellas Pharma Global Development, Inc.

Disqualifiers: Did not complete ISEE2008, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 17 months

278 Participants Needed

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).

Research Team

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

17 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

Open-label extension

Participants continue to receive avacincaptad pegol to assess long-term safety

18 months

Treatment Details

Interventions

• Avacincaptad Pegol

Trial Overview 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.

Participant Groups

Group I: avacincaptad pegol Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

IVERIC bio, Inc.

Lead Sponsor

Trials

5

Recruited

1,100+