Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
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)
3 other identifiers
interventional
278
16 countries
115
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2022
Typical duration for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2025
CompletedResults Posted
Study results publicly available
April 14, 2026
CompletedMay 1, 2026
April 1, 2026
2.5 years
September 7, 2022
March 26, 2026
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to 18 months
Secondary Outcomes (2)
Number of Participants With Anti-drug Antibody (ADA)
Up to 18 months
Plasma Concentrations of ACP
Months 1, 2, 4, 7, 13, and 18
Study Arms (1)
avacincaptad pegol
EXPERIMENTALParticipants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.
Interventions
Intravitreal Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (117)
Retinal Diagnostic Center
Campbell, California, 95008, United States
Eye Medical Center of Fresno
Fresno, California, 93720, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
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
Doheny Eye Center, UCLA
Pasadena, California, 91105, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Orange County Retinal Med Group
Santa Ana, California, 92705, United States
University of Colorado
Aurora, Colorado, 80045, United States
Retina Consultants of Southern CO
Colorado Springs, Colorado, 80909, United States
Colorado Retina Associates, PC
Lakewood, Colorado, 80228, United States
Rand Eye Institute
Deerfield Beach, Florida, 33064, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Retina Associates of Sarasota
Sarasota, Florida, 34233, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Southern Vitreoretinal Associates
Tallahassee, Florida, 32308, United States
Center for Retina & Macula Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center P.C.
Augusta, Georgia, 30909, United States
Retina Consultants of Hawaii, Inc.
‘Aiea, Hawaii, 96701, United States
Illinois Eye Center
Peoria, Illinois, 61615, United States
Vitreo Retinal Consultants & Surgeons
Wichita, Kansas, 67214, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70124, United States
The Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Retina Research Institute at New England Retina
Springfield, Massachusetts, 01107, United States
Vitreoretinal Associates PC
Worcester, Massachusetts, 01605, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Retina Vitreous Surgeons of Central New York
Liverpool, New York, 13088, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, 11572, United States
Retina Associates of Western NY
Rochester, New York, 14620, United States
Western Carolina Retinal Associates
Asheville, North Carolina, 28803, United States
Retina & Vitreous Center of Southern Oregon, PC
Ashland, Oregon, 97520, United States
Retina Northwest PC
Portland, Oregon, 97221, United States
Eye Health Northwest
Portland, Oregon, 97225, United States
Mid Atlantic Retina - Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
Associates in Ophthalmology
West Mifflin, Pennsylvania, 15122, United States
Retina Research of Beaufort
Beaufort, South Carolina, 29902, United States
Palmetto Retina Center
West Columbia, South Carolina, 29169, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Southeastern Retina Associates, PC
Knoxville, Tennessee, 37922, United States
Retina Research Institute of Texas, LLC
Abilene, Texas, 79606, United States
Southwest Retina Specialists
Amarillo, Texas, 79106, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Retina Center of Texas
Southlake, Texas, 76092, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Associates of Utah PC
Salt Lake City, Utah, 84107, United States
Pacific Northwest Retina
Bellevue, Washington, 98004, United States
Oftalmólogos Especialistas
Rosario, Sante Fe, S2000ANJ, Argentina
Centro Oftalmológico Dr. Charles
Buenos Aires, 1116, Argentina
Instituto Oftalmologico de Buenos Aires
Buenos Aires, 1830, Argentina
Oftar Mendoza
Mendoza, 5500, Argentina
Microcirugia Ocular
Santa Fe, Argentina
Centre for Eye Research Australia
East Melbourne, 3002, Australia
Sydney Retina Clinic
Sydney, 2000, Australia
Medizinische Universitat Graz
Styria, 8036, Austria
Medizinische Universitat Innsbruck
Tyrol, 6020, Austria
Medical University of Vienna, Department of Ophthalmology and Optometry
Vienna, 1090, Austria
Centre H. U. Brugmann
Brussels, 1020, Belgium
Centro de Ensino e Pesquisa do Instituto de Visao
Belo Horizonte, 30330-00, Brazil
Universidade Federal de Sao Paulo
São Paulo, 04023-062, Brazil
IPEPO - Instituto da Visao
São Paulo, 04038-032, Brazil
Calgary Retina Consultants
Calgary, Alberta, T2H 0C8, Canada
St. Joseph's Health Care London
London, Ontario, N6A4V2, Canada
Retina Centre of Ottawa
Ottawa, Ontario, K2B 7E9, Canada
Fundacion Oftalmologica Nacional
Bogotá, 110231, Colombia
Clinica de Oftalmologia Sandiego
Medellín, 00000, Colombia
Clinical Hospital Osiiek, Ophthalmology Clinic
Osijek, 31000, Croatia
Lékárna nad Knížecí Kováků
Smíchov, 150 00, Czechia
University Hospital of Bordeaux
Bordeaux, 33000, France
Hopital Intercommunal de Creteil
Créteil, 94010, France
Pole Vision Val D'Ouest
Écully, 69130, France
Centre Ophtalmologique Rabelais
Lyon, 69002, France
Hopital de la Croix-Rousse
Lyon, 69317, France
Centre Paradis-Monticelli
Marseille, 13008, France
Centre D'exploration Ophtalmologique De L'odéon
Paris, 75006, France
Centre d'Imagerie et Laser
Paris, 75015, France
Rothschild Foundation
Paris, 75019, France
Hopital Lariboisiere, Service Pharmacie
Paris, 75745, France
Centre Ophtalmologique Saint Exupéry
Saint-Cyr-sur-Loire, 37540, France
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20251, Germany
Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover
Hanover, 30625, Germany
Augenklinik der Ludwig-Maximilian Universität München
München, 80336, Germany
Eye Clinic Ludwig Maximilian
München, 80336, Germany
Augenzentrum am St. Franziskus-Hospital
Münster, 48145, Germany
Dept. of Ophthalmology Semmelweis University Budapest
Budapest, 1085, Hungary
Bajcsy Zsilinszky Korhaz Szemeszet
Budapest, 1106, Hungary
Budapest Retina Associates
Budapest, 1133, Hungary
Barzilai Medical Center
Ashkelon, 7830604, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Kaplan Medical Center
Rehovot, 94410606, Israel
Shamir Medical Center
Tzrifin, 70300, Israel
AOU Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Clinica Oftalmologica Ospedale C. S.S. Annunziata
Chieti, 66100, Italy
Ospedaliero Universitaria di Ferrara
Ferrara, 44124, Italy
Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliera Fatebenefratelli
Milan, 20157, Italy
Azienda Ospedaliera U. della Campania "Vanvitelli"
Naples, 80131, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Azienda Ospedaliero-U.Ospedali Riuniti Umberto I
Torrette Di Ancona, 60126, Italy
P. Stradins Clinical university hospital
Riga, LV-1002, Latvia
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, 28222, Spain
Clinicade Oftalmologia Barraquer
Barcelona, 08021, Spain
Institut Catala de la Retina
Barcelona, 08022, Spain
Instituto Clinico Quirurgico de Oftalmologia
Bilbao, 48010, Spain
Hospital La Arruzafa
Córdoba, 14003, Spain
Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro
Sant Cugat del Vallès, 08195, Spain
Instituto Oftalmológico Gómez-Ulla
Santiago de Compostela, 15706, Spain
IMED Servicio Oftalmología
Valencia, 46100, Spain
Rio Hortega University Hospital
Valladolid, 47012, Spain
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, 50009, Spain
Related Links
- PLS (Czech)
- PLS (French)
- PLS (German)
- PLS (Hebrew)
- PLS (Hungarian)
- PLS (Italian)
- PLS (Polish)
- PLS (Portuguese)
- PLS (Spanish)
- PLS (Croatian)
- Link to plain language summary of the study on the Trial Results Summaries website.
- Link to results and other applicable study documents on the Astellas Clinical Trials website.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Astellas Pharma Global Development, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 10, 2022
Study Start
September 26, 2022
Primary Completion
April 10, 2025
Study Completion
April 10, 2025
Last Updated
May 1, 2026
Results First Posted
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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/.