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.
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
- Conditions the study is for
- Geographic Atrophy, Age-Related Macular Degeneration
- 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
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- Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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
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
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
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
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
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
Israel4 sites
Barzilai Medical Center
Ashkelon, 7830604
Carmel Medical Center
Haifa, 3436212
Kaplan Medical Center
Rehovot, 94410606
Shamir Medical Center
Tzrifin, 70300
Austria3 sites
Medizinische Universitat Graz
Styria, 8036
Medizinische Universitat Innsbruck
Tyrol, 6020
Medical University of Vienna, Department of Ophthalmology and Optometry
Vienna, 1090
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
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
Hungary3 sites
Dept. of Ophthalmology Semmelweis University Budapest
Budapest, 1085
Bajcsy Zsilinszky Korhaz Szemeszet
Budapest, 1106
Budapest Retina Associates
Budapest, 1133
Australia2 sites
Centre for Eye Research Australia
East Melbourne, 3002
Sydney Retina Clinic
Sydney, 2000
Colombia2 sites
Fundacion Oftalmologica Nacional
Bogotá, 110231
Clinica de Oftalmologia Sandiego
Medellín, 00000
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 group | Role | What they receive |
|---|---|---|
| avacincaptad pegol | Experimental | Participants 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.
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)
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
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.
- First posted10 Sep 2022
- Study start26 Sep 2022
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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/.