Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
- Conditions
- Geographic AtrophyAge-Related Macular Degeneration
- Interventions
- Registration Number
- NCT05536297
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- 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 24 visit on study treatment (either avacincaptad pegol or Sham).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- 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.
- 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- Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description avacincaptad pegol avacincaptad pegol Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Up to 18 Months 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 should be considered when a participant requires new or additional treatment for that illness.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration Up to 18 Months Concentration will be recorded from the PK plasma samples collected.
Number of participants with Anti-Drug Antibody (ADA) status Up to 18 Months ADA will be recorded from the serum samples collected. Overall ADA status will be reported: ADA-negative, ADA positive, ADA-inconclusive and unevaluable sample.
Trial Locations
- Locations (117)
Mid Atlantic Retina - Wills Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Rand Eye Institute
🇺🇸Deerfield Beach, Florida, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Retina Northwest PC
🇺🇸Portland, Oregon, United States
Eye Health Northwest
🇺🇸Portland, Oregon, United States
Pole Vision Val D'Ouest
🇫🇷Ecully, France
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
Doheny Eye Center, UCLA
🇺🇸Pasadena, California, United States
Colorado Retina Associates, PC
🇺🇸Lakewood, Colorado, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Retina Associates of Sarasota
🇺🇸Sarasota, Florida, United States
Retina Consultants of Hawaii, Inc.
🇺🇸'Aiea, Hawaii, United States
Center for Retina & Macula Disease
🇺🇸Winter Haven, Florida, United States
Vitreo Retinal Consultants & Surgeons
🇺🇸Wichita, Kansas, United States
Southeast Retina Center P.C.
🇺🇸Augusta, Georgia, United States
Illinois Eye Center
🇺🇸Peoria, Illinois, United States
The Retina Group of Washington
🇺🇸Chevy Chase, Maryland, United States
Retina Research Institute at New England Retina
🇺🇸Springfield, Massachusetts, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Vitreoretinal Associates PC
🇺🇸Worcester, Massachusetts, United States
Ophthalmic Consultants of Long Island
🇺🇸Oceanside, New York, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Retina & Vitreous Center of Southern Oregon, PC
🇺🇸Ashland, Oregon, United States
Retina Vitreous Surgeons of Central New York
🇺🇸Liverpool, New York, United States
Retina Research of Beaufort
🇺🇸Beaufort, South Carolina, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Southeastern Retina Associates, PC
🇺🇸Knoxville, Tennessee, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Pacific Northwest Retina
🇺🇸Bellevue, Washington, United States
Retina Associates of Utah PC
🇺🇸Salt Lake City, Utah, United States
Oftalmólogos Especialistas
🇦🇷Rosario, Sante Fe, Argentina
Microcirugia Ocular
🇦🇷Santa Fe, Argentina
Centro Oftalmológico Dr. Charles
🇦🇷Buenos Aires, Argentina
Instituto Oftalmologico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Centre for Eye Research Australia
🇦🇺East Melbourne, Australia
Medizinische Universitat Graz
🇦🇹Styria, Austria
Sydney Retina Clinic
🇦🇺Sydney, Australia
Medizinische Universitat Innsbruck
🇦🇹Tyrol, Austria
Medical University of Vienna, Department of Ophthalmology and Optometry
🇦🇹Vienna, Austria
Centre H. U. Brugmann
🇧🇪Brussels, Belgium
IPEPO - Instituto da Visao
🇧🇷São Paulo, Brazil
Calgary Retina Consultants
🇨🇦Calgary, Alberta, Canada
Universidade Federal de Sao Paulo
🇧🇷São Paulo, Brazil
Fundacion Oftalmologica Nacional
🇨🇴Bogota, Colombia
Retina Centre of Ottawa
🇨🇦Ottawa, Ontario, Canada
Clinical Hospital Osiiek, Ophthalmology Clinic
🇭🇷Osijek, Croatia
Lékárna nad Knížecí Kováků
🇨🇿Smíchov, Czechia
Centre Ophtalmologique Rabelais
🇫🇷Lyon, France
University Hospital of Bordeaux
🇫🇷Bordeaux, France
Hopital Intercommunal de Creteil
🇫🇷Créteil, France
Hopital de la Croix-Rousse
🇫🇷Lyon, France
Clinica de Oftalmologia Sandiego
🇨🇴Medellin, Colombia
Centre Paradis-Monticelli
🇫🇷Marseille, France
Centre D'exploration Ophtalmologique De L'odéon
🇫🇷Paris, France
Centre d'Imagerie et Laser
🇫🇷Paris, France
Rothschild Foundation
🇫🇷Paris, France
Hopital Lariboisiere, Service Pharmacie
🇫🇷Paris, France
Centre Ophtalmologique Saint Exupéry
🇫🇷Saint Cyr sur Loire, France
Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Eye Clinic Ludwig Maximilian
🇩🇪München, Germany
Augenklinik der Ludwig-Maximilian Universität München
🇩🇪München, Germany
Augenzentrum am St. Franziskus-Hospital
🇩🇪Münster, Germany
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Bajcsy Zsilinszky Korhaz Szemeszet
🇭🇺Budapest, Hungary
Dept. of Ophthalmology Semmelweis University Budapest
🇭🇺Budapest, Hungary
Budapest Retina Associates
🇭🇺Budapest, Hungary
Kaplan Medical Center
🇮🇱Rehovot, Israel
Shamir Medical Center
🇮🇱Tzrifin, Israel
AOU Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Clinica Oftalmologica Ospedale C. S.S. Annunziata
🇮🇹Chieti, Italy
Ospedaliero Universitaria di Ferrara
🇮🇹Ferrara, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera Fatebenefratelli
🇮🇹Milano, Italy
Azienda Ospedaliero-U.Ospedali Riuniti Umberto I
🇮🇹Torrette Di Ancona, Italy
Azienda Ospedaliera U. della Campania "Vanvitelli"
🇮🇹Napoli, Italy
Hospital Universitario Puerta de Hierro-Majadahonda
🇪🇸Majadahonda, Madrid, Spain
P. Stradins Clinical university hospital
🇱🇻Riga, Latvia
Clinicade Oftalmologia Barraquer
🇪🇸Barcelona, Spain
Instituto Clinico Quirurgico de Oftalmologia
🇪🇸Bilbao, Spain
Institut Catala de la Retina
🇪🇸Barcelona, Spain
Hospital La Arruzafa
🇪🇸Cordoba, Spain
IMED Servicio Oftalmología
🇪🇸Valencia, Spain
Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro
🇪🇸Sant Cugat del Valles, Spain
Hospital Clínico Universitario "Lozano Blesa"
🇪🇸Zaragoza, Spain
Instituto Oftalmológico Gómez-Ulla
🇪🇸Santiago de Compostela, Spain
Rio Hortega University Hospital
🇪🇸Valladolid, Spain
Retina Care Specialists
🇺🇸Palm Beach Gardens, Florida, United States
Southern Vitreoretinal Associates
🇺🇸Tallahassee, Florida, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Southwest Retina Specialists
🇺🇸Amarillo, Texas, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Retina Center of Texas
🇺🇸Southlake, Texas, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Carmel Medical Center
🇮🇱Haifa, Israel
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Jules Stein Eye Institute David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
Jacobs Retina Center at The Shiley Eye Institute USCD
🇺🇸La Jolla, California, United States
Eye Medical Center of Fresno
🇺🇸Fresno, California, United States
Retina Consultants of Southern CO
🇺🇸Colorado Springs, Colorado, United States
Orange County Retinal Med Group
🇺🇸Santa Ana, California, United States
Retina Consultants of Southern California
🇺🇸Redlands, California, United States
Western Carolina Retinal Associates
🇺🇸Asheville, North Carolina, United States
Retina Associates of Western NY
🇺🇸Rochester, New York, United States
Associates in Ophthalmology
🇺🇸West Mifflin, Pennsylvania, United States
Retina Research Institute of Texas, LLC
🇺🇸Abilene, Texas, United States
Oftar Mendoza
🇦🇷Mendoza, Argentina
Centro de Ensino e Pesquisa do Instituto de Visao
🇧🇷Belo Horizonte, Brazil
Policlinico Tor Vergata
🇮🇹Roma, Italy
University of Colorado
🇺🇸Aurora, Colorado, United States
St. Joseph's Health Care London
🇨🇦London, Ontario, Canada