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Eye drug safety check for advanced macular degeneration

NCT ID NCT05536297

Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checks the long-term safety of an eye injection called avacincaptad pegol for people with geographic atrophy, a form of advanced age-related macular degeneration that causes vision loss. About 278 adults who finished a previous study of this drug will receive the injection and be monitored for side effects over 18 months. The goal is to see if the drug is safe to use over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

278 people

The number who actually took part.

Started

Sep 2022

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration Geographic Atrophy macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Age-related macular degeneration Geographic atrophy

Contacts and locations

Locations

  • AOU Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Associates in Ophthalmology

    West Mifflin, Pennsylvania, 15122, United States

  • Augenklinik der Ludwig-Maximilian Universität München

    München, 80336, Germany

  • Augenzentrum am St. Franziskus-Hospital

    Münster, 48145, Germany

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Azienda Ospedaliera Fatebenefratelli

    Milan, 20157, Italy

  • Azienda Ospedaliera U. della Campania "Vanvitelli"

    Naples, 80131, Italy

  • Azienda Ospedaliero-U.Ospedali Riuniti Umberto I

    Torrette Di Ancona, 60126, Italy

  • Bajcsy Zsilinszky Korhaz Szemeszet

    Budapest, 1106, Hungary

  • Barzilai Medical Center

    Ashkelon, 7830604, Israel

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701, United States

  • Budapest Retina Associates

    Budapest, 1133, Hungary

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8, Canada

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Center for Retina & Macula Disease

    Winter Haven, Florida, 33880, United States

  • Centre D'exploration Ophtalmologique De L'odéon

    Paris, 75006, France

  • Centre H. U. Brugmann

    Brussels, 1020, Belgium

  • Centre Ophtalmologique Rabelais

    Lyon, 69002, France

  • Centre Ophtalmologique Saint Exupéry

    Saint-Cyr-sur-Loire, 37540, France

  • Centre Paradis-Monticelli

    Marseille, 13008, France

  • Centre d'Imagerie et Laser

    Paris, 75015, France

  • Centre for Eye Research Australia

    East Melbourne, 3002, Australia

  • Centro Oftalmológico Dr. Charles

    Buenos Aires, 1116, Argentina

  • Centro de Ensino e Pesquisa do Instituto de Visao

    Belo Horizonte, 30330-00, Brazil

  • Clinica Oftalmologica Ospedale C. S.S. Annunziata

    Chieti, 66100, Italy

  • Clinica de Oftalmologia Sandiego

    Medellín, 00000, Colombia

  • Clinicade Oftalmologia Barraquer

    Barcelona, 08021, Spain

  • Clinical Hospital Osiiek, Ophthalmology Clinic

    Osijek, 31000, Croatia

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Dept. of Ophthalmology Semmelweis University Budapest

    Budapest, 1085, Hungary

  • Doheny Eye Center, UCLA

    Pasadena, California, 91105, United States

  • East Florida Eye Institute

    Stuart, Florida, 34994, United States

  • Eye Clinic Ludwig Maximilian

    München, 80336, Germany

  • Eye Health Northwest

    Portland, Oregon, 97225, United States

  • Eye Medical Center of Fresno

    Fresno, California, 93720, United States

  • Florida Eye Associates

    Melbourne, Florida, 32901, United States

  • Fundacion Oftalmologica Nacional

    Bogotá, 110231, Colombia

  • Hopital Intercommunal de Creteil

    Créteil, 94010, France

  • Hopital Lariboisiere, Service Pharmacie

    Paris, 75745, France

  • Hopital de la Croix-Rousse

    Lyon, 69317, France

  • Hospital Clínico Universitario "Lozano Blesa"

    Zaragoza, 50009, Spain

  • Hospital La Arruzafa

    Córdoba, 14003, Spain

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • IMED Servicio Oftalmología

    Valencia, 46100, Spain

  • IPEPO - Instituto da Visao

    São Paulo, 04038-032, Brazil

  • Illinois Eye Center

    Peoria, Illinois, 61615, United States

  • Institut Catala de la Retina

    Barcelona, 08022, Spain

  • Instituto Clinico Quirurgico de Oftalmologia

    Bilbao, 48010, Spain

  • Instituto Oftalmologico de Buenos Aires

    Buenos Aires, 1830, Argentina

  • Instituto Oftalmológico Gómez-Ulla

    Santiago de Compostela, 15706, Spain

  • Jacobs Retina Center at The Shiley Eye Institute USCD

    La Jolla, California, 92093, United States

  • Jules Stein Eye Institute David Geffen School of Medicine

    Los Angeles, California, 90095, United States

  • Kaplan Medical Center

    Rehovot, 94410606, Israel

  • Lékárna nad Knížecí Kováků

    Smíchov, 150 00, Czechia

  • Medical University of Vienna, Department of Ophthalmology and Optometry

    Vienna, 1090, Austria

  • Medizinische Universitat Graz

    Styria, 8036, Austria

  • Medizinische Universitat Innsbruck

    Tyrol, 6020, Austria

  • Microcirugia Ocular

    Santa Fe, Argentina

  • Mid Atlantic Retina - Wills Eye Institute

    Philadelphia, Pennsylvania, 19107, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70124, United States

  • Oftalmólogos Especialistas

    Rosario, Sante Fe, S2000ANJ, Argentina

  • Oftar Mendoza

    Mendoza, 5500, Argentina

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114, United States

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572, United States

  • Orange County Retinal Med Group

    Santa Ana, California, 92705, United States

  • Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Ospedaliero Universitaria di Ferrara

    Ferrara, 44124, Italy

  • P. Stradins Clinical university hospital

    Riga, LV-1002, Latvia

  • Pacific Northwest Retina

    Bellevue, Washington, 98004, United States

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Pole Vision Val D'Ouest

    Écully, 69130, France

  • Policlinico Tor Vergata

    Roma, 00133, Italy

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064, United States

  • Retina & Vitreous Center of Southern Oregon, PC

    Ashland, Oregon, 97520, United States

  • Retina Associates of Sarasota

    Sarasota, Florida, 34233, United States

  • Retina Associates of Utah PC

    Salt Lake City, Utah, 84107, United States

  • Retina Associates of Western NY

    Rochester, New York, 14620, United States

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410, United States

  • Retina Center of Texas

    Southlake, Texas, 76092, United States

  • Retina Centre of Ottawa

    Ottawa, Ontario, K2B 7E9, Canada

  • Retina Consultants of Hawaii, Inc.

    ‘Aiea, Hawaii, 96701, United States

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Orange County

    Fullerton, California, 92835, United States

  • Retina Consultants of Southern CO

    Colorado Springs, Colorado, 80909, United States

  • Retina Consultants of Southern California

    Redlands, California, 92374, United States

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231, United States

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308, United States

  • Retina Northwest PC

    Portland, Oregon, 97221, United States

  • Retina Research Institute at New England Retina

    Springfield, Massachusetts, 01107, United States

  • Retina Research Institute of Texas, LLC

    Abilene, Texas, 79606, United States

  • Retina Research of Beaufort

    Beaufort, South Carolina, 29902, United States

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711, United States

  • Retina Vitreous Surgeons of Central New York

    Liverpool, New York, 13088, United States

  • Retinal Diagnostic Center

    Campbell, California, 95008, United States

  • Rio Hortega University Hospital

    Valladolid, 47012, Spain

  • Rothschild Foundation

    Paris, 75019, France

  • Shamir Medical Center

    Tzrifin, 70300, Israel

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • Southeast Retina Center P.C.

    Augusta, Georgia, 30909, United States

  • Southeastern Retina Associates, PC

    Knoxville, Tennessee, 37922, United States

  • Southern Vitreoretinal Associates

    Tallahassee, Florida, 32308, United States

  • Southwest Retina Specialists

    Amarillo, Texas, 79106, United States

  • St. Joseph's Health Care London

    London, Ontario, N6A4V2, Canada

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087, United States

  • Sydney Retina Clinic

    Sydney, 2000, Australia

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815, United States

  • Universidade Federal de Sao Paulo

    São Paulo, 04023-062, Brazil

  • University Hospital of Bordeaux

    Bordeaux, 33000, France

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20251, Germany

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

    Sant Cugat del Vallès, 08195, Spain

  • Vitreo Retinal Consultants & Surgeons

    Wichita, Kansas, 67214, United States

  • Vitreoretinal Associates PC

    Worcester, Massachusetts, 01605, United States

  • Western Carolina Retinal Associates

    Asheville, North Carolina, 28803, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.