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Geographic AtrophyPhase 3NCT05536297

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

A Phase 3 study testing avacincaptad pegol in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Astellas Pharma Global Development, Inc. at 117 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 23 visit on study treatment (either avacincaptad pegol or Sham). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
avacincaptad pegol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
278 participants
Where
117 sitesin 17 countries
Study dates
26 Sep 2022to 10 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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  • Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

117 sites in 17 countries.

117 sites in 17 countries

United States53 sites

  • Retina Consultants of Hawaii, Inc.

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas, LLC

    Abilene, Texas, 79606

  • Southwest Retina Specialists

    Amarillo, Texas, 79106

  • Western Carolina Retinal Associates

    Asheville, North Carolina, 28803

  • Retina & Vitreous Center of Southern Oregon, PC

    Ashland, Oregon, 97520

  • Southeast Retina Center P.C.

    Augusta, Georgia, 30909

  • University of Colorado

    Aurora, Colorado, 80045

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research of Beaufort

    Beaufort, South Carolina, 29902

  • Pacific Northwest Retina

    Bellevue, Washington, 98004

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Retina Consultants of Southern CO

    Colorado Springs, Colorado, 80909

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Eye Medical Center of Fresno

    Fresno, California, 93720

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Southeastern Retina Associates, PC

    Knoxville, Tennessee, 37922

  • Jacobs Retina Center at The Shiley Eye Institute USCD

    La Jolla, California, 92093

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228

  • Retina Vitreous Surgeons of Central New York

    Liverpool, New York, 13088

  • Jules Stein Eye Institute David Geffen School of Medicine

    Los Angeles, California, 90095

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70124

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Doheny Eye Center, UCLA

    Pasadena, California, 91105

  • Illinois Eye Center

    Peoria, Illinois, 61615

  • Mid Atlantic Retina - Wills Eye Institute

    Philadelphia, Pennsylvania, 19107

  • Retina Northwest PC

    Portland, Oregon, 97221

  • Eye Health Northwest

    Portland, Oregon, 97225

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Associates of Western NY

    Rochester, New York, 14620

  • Retina Associates of Utah PC

    Salt Lake City, Utah, 84107

  • Orange County Retinal Med Group

    Santa Ana, California, 92705

  • Retina Associates of Sarasota

    Sarasota, Florida, 34233

  • Retina Center of Texas

    Southlake, Texas, 76092

  • Retina Research Institute at New England Retina

    Springfield, Massachusetts, 01107

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • Southern Vitreoretinal Associates

    Tallahassee, Florida, 32308

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Associates in Ophthalmology

    West Mifflin, Pennsylvania, 15122

  • Vitreo Retinal Consultants & Surgeons

    Wichita, Kansas, 67214

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Center for Retina & Macula Disease

    Winter Haven, Florida, 33880

  • Vitreoretinal Associates PC

    Worcester, Massachusetts, 01605

Other trials in United States

France11 sites

  • University Hospital of Bordeaux

    Bordeaux, 33000

  • Hopital Intercommunal de Creteil

    Créteil, 94010

  • Pole Vision Val D'Ouest

    Écully, 69130

  • Centre Ophtalmologique Rabelais

    Lyon, 69002

  • Hopital de la Croix-Rousse

    Lyon, 69317

  • Centre Paradis-Monticelli

    Marseille, 13008

  • Centre D'exploration Ophtalmologique De L'odéon

    Paris, 75006

  • Centre d'Imagerie et Laser

    Paris, 75015

  • Rothschild Foundation

    Paris, 75019

  • Hopital Lariboisiere, Service Pharmacie

    Paris, 75745

  • Centre Ophtalmologique Saint Exupéry

    Saint-Cyr-sur-Loire, 37540

Other trials in France

Spain10 sites

  • Clinicade Oftalmologia Barraquer

    Barcelona, 08021

  • Institut Catala de la Retina

    Barcelona, 08022

  • Instituto Clinico Quirurgico de Oftalmologia

    Bilbao, 48010

  • Hospital La Arruzafa

    Córdoba, 14003

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, Madrid, 28222

  • Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro

    Sant Cugat del Vallès, 08195

  • Instituto Oftalmológico Gómez-Ulla

    Santiago de Compostela, 15706

  • IMED Servicio Oftalmología

    Valencia, 46100

  • Rio Hortega University Hospital

    Valladolid, 47012

  • Hospital Clínico Universitario "Lozano Blesa"

    Zaragoza, 50009

Other trials in Spain

Italy9 sites

  • AOU Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Clinica Oftalmologica Ospedale C. S.S. Annunziata

    Chieti, 66100

  • Ospedaliero Universitaria di Ferrara

    Ferrara, 44124

  • Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Fatebenefratelli

    Milan, 20157

  • Azienda Ospedaliera U. della Campania "Vanvitelli"

    Naples, 80131

  • Policlinico Tor Vergata

    Roma, 00133

  • Azienda Ospedaliero-U.Ospedali Riuniti Umberto I

    Torrette Di Ancona, 60126

Other trials in Italy

Argentina5 sites

  • Centro Oftalmológico Dr. Charles

    Buenos Aires, 1116

  • Instituto Oftalmologico de Buenos Aires

    Buenos Aires, 1830

  • Oftar Mendoza

    Mendoza, 5500

  • Oftalmólogos Especialistas

    Rosario, Sante Fe, S2000ANJ

  • Microcirugia Ocular

    Santa Fe

Other trials in Argentina

Germany5 sites

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20251

  • Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover

    Hanover, 30625

  • Augenklinik der Ludwig-Maximilian Universität München

    München, 80336

  • Eye Clinic Ludwig Maximilian

    München, 80336

  • Augenzentrum am St. Franziskus-Hospital

    Münster, 48145

Other trials in Germany

Israel4 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Carmel Medical Center

    Haifa, 3436212

  • Kaplan Medical Center

    Rehovot, 94410606

  • Shamir Medical Center

    Tzrifin, 70300

Other trials in Israel

Austria3 sites

  • Medizinische Universitat Graz

    Styria, 8036

  • Medizinische Universitat Innsbruck

    Tyrol, 6020

  • Medical University of Vienna, Department of Ophthalmology and Optometry

    Vienna, 1090

Other trials in Austria

Brazil3 sites

  • Centro de Ensino e Pesquisa do Instituto de Visao

    Belo Horizonte, 30330-00

  • Universidade Federal de Sao Paulo

    São Paulo, 04023-062

  • IPEPO - Instituto da Visao

    São Paulo, 04038-032

Other trials in Brazil

Canada3 sites

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8

  • St. Joseph's Health Care London

    London, Ontario, N6A4V2

  • Retina Centre of Ottawa

    Ottawa, Ontario, K2B 7E9

Other trials in Canada

Hungary3 sites

  • Dept. of Ophthalmology Semmelweis University Budapest

    Budapest, 1085

  • Bajcsy Zsilinszky Korhaz Szemeszet

    Budapest, 1106

  • Budapest Retina Associates

    Budapest, 1133

Other trials in Hungary

Australia2 sites

  • Centre for Eye Research Australia

    East Melbourne, 3002

  • Sydney Retina Clinic

    Sydney, 2000

Other trials in Australia

Colombia2 sites

  • Fundacion Oftalmologica Nacional

    Bogotá, 110231

  • Clinica de Oftalmologia Sandiego

    Medellín, 00000

Other trials in Colombia

Belgium1 site

  • Centre H. U. Brugmann

    Brussels, 1020

Other trials in Belgium

Croatia1 site

  • Clinical Hospital Osiiek, Ophthalmology Clinic

    Osijek, 31000

Other trials in Croatia

Czechia1 site

  • Lékárna nad Knížecí Kováků

    Smíchov, 150 00

Other trials in Czechia

Latvia1 site

  • P. Stradins Clinical university hospital

    Riga, LV-1002

Other trials in Latvia

About this study

Official title: An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)

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

Being tested
avacincaptad pegol
Keywords
Geographic Atrophy;, Macular Degeneration;, ARC1905;, Avacincaptad pegol;, Zimura (previous name);, Izervay
Medical subject headings
Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • avacincaptad pegolDrug

    Also called Zimura (previous name), ARC1905, Izervay

    Intravitreal Injection

Study groups in NCT05536297
Study groupRoleWhat they receive
avacincaptad pegolExperimentalParticipants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.
Receives: Drug: avacincaptad pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs)

    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 was considered when a participant requires new or additional treatment for that illness. Lack of or insufficient clinical response or efficacy was not recorded as an AE.

    Measured: Up to 18 months

Secondary outcomes (2)

  1. Number of Participants With Anti-drug Antibody (ADA)

    Number of participants with ADA = Post-baseline positive (in Baseline negative group) + treatment-boosted ADA positive (in Baseline positive group) / participants with a Baseline and at least one post-baseline sample.

    For participants whose ADA status is positive at Baseline, a post-baseline titer value that is >= 4 times higher than the Baseline is considered treatment-boosted ADA.

    Measured: Up to 18 months

  2. Plasma Concentrations of ACP

    Concentrations below the lower limit of quantification (3.36 ng/mL) are set to zero for calculation of summary statistics.

    Measured: Months 1, 2, 4, 7, 13, and 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2022
  2. Study start26 Sep 2022
  3. Primary completion10 Apr 2025
  4. Study completion10 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536297
Sponsor's protocol ID
ISEE2009
Other IDs
2022-002860-59, 2024-515185-13-00
Status last verified
May 2026
First submitted
7 Sep 2022
Last updated
18 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing avacincaptad pegol in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Astellas Pharma Global Development, Inc. at 117 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, France, Spain, Italy, Argentina and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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