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The trial is taking place at:
A

Austin Retina Associates | Main | Austin, TX

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Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

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  • Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

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

Trial contacts and locations

117

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Data sourced from clinicaltrials.gov

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