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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05536297
Other study ID # ISEE2009
Secondary ID 2022-002860-59
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 26, 2022
Est. completion date March 31, 2025

Study information

Verified date April 2024
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 24 visit on study treatment (either avacincaptad pegol or Sham).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 278
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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the Month 24 visit on study treatment (either avacincaptad pegol or Sham), - Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

Study Design


Intervention

Drug:
avacincaptad pegol
Intravitreal Injection

Locations

Country Name City State
Argentina Centro Oftalmológico Dr. Charles Buenos Aires
Argentina Instituto Oftalmologico de Buenos Aires Buenos Aires
Argentina Oftar Mendoza Mendoza
Argentina Oftalmólogos Especialistas Rosario Sante Fe
Argentina Microcirugia Ocular Santa Fe
Australia Centre for Eye Research Australia East Melbourne
Australia Sydney Retina Clinic Sydney
Austria Medizinische Universitat Graz Styria
Austria Medizinische Universitat Innsbruck Tyrol
Austria Medical University of Vienna, Department of Ophthalmology and Optometry Vienna
Belgium Centre H. U. Brugmann Brussels
Brazil Centro de Ensino e Pesquisa do Instituto de Visao Belo Horizonte
Brazil IPEPO - Instituto da Visao São Paulo
Brazil Universidade Federal de Sao Paulo São Paulo
Canada Calgary Retina Consultants Calgary Alberta
Canada St. Joseph's Health Care London London Ontario
Canada Retina Centre of Ottawa Ottawa Ontario
Colombia Fundacion Oftalmologica Nacional Bogota
Colombia Clinica de Oftalmologia Sandiego Medellin
Croatia Clinical Hospital Osiiek, Ophthalmology Clinic Osijek
Czechia Lékárna nad Knížecí Kováku Smíchov
France University Hospital of Bordeaux Bordeaux
France Hopital Intercommunal de Creteil Créteil
France Pole Vision Val D'Ouest Ecully
France Centre Ophtalmologique Rabelais Lyon
France Hopital de la Croix-Rousse Lyon
France Centre Paradis-Monticelli Marseille
France Centre D'exploration Ophtalmologique De L'odéon Paris
France Centre d'Imagerie et Laser Paris
France Hopital Lariboisiere, Service Pharmacie Paris
France Rothschild Foundation Paris
France Centre Ophtalmologique Saint Exupéry Saint Cyr sur Loire
Germany Universitätsklinikum Hamburg Eppendorf Hamburg
Germany Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover Hannover
Germany Augenklinik der Ludwig-Maximilian Universität München München
Germany Eye Clinic Ludwig Maximilian München
Germany Augenzentrum am St. Franziskus-Hospital Münster
Hungary Bajcsy Zsilinszky Korhaz Szemeszet Budapest
Hungary Budapest Retina Associates Budapest
Hungary Dept. of Ophthalmology Semmelweis University Budapest Budapest
Israel Barzilai Medical Center Ashkelon
Israel Carmel Medical Center Haifa
Israel Kaplan Medical Center Rehovot
Israel Shamir Medical Center Tzrifin
Italy AOU Policlinico S. Orsola-Malpighi Bologna
Italy Clinica Oftalmologica Ospedale C. S.S. Annunziata Chieti
Italy Ospedaliero Universitaria di Ferrara Ferrara
Italy Azienda Ospedaliera Fatebenefratelli Milano
Italy Ospedale Maggiore Policlinico Milano
Italy Ospedale San Raffaele Milano
Italy Azienda Ospedaliera U. della Campania "Vanvitelli" Napoli
Italy Policlinico Tor Vergata Roma
Italy Azienda Ospedaliero-U.Ospedali Riuniti Umberto I Torrette Di Ancona
Latvia P. Stradins Clinical university hospital Riga
Spain Clinicade Oftalmologia Barraquer Barcelona
Spain Institut Catala de la Retina Barcelona
Spain Instituto Clinico Quirurgico de Oftalmologia Bilbao
Spain Hospital La Arruzafa Cordoba
Spain Hospital Universitario Puerta de Hierro-Majadahonda Majadahonda Madrid
Spain Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro Sant Cugat del Valles
Spain Instituto Oftalmológico Gómez-Ulla Santiago de Compostela
Spain IMED Servicio Oftalmología Valencia
Spain Rio Hortega University Hospital Valladolid
Spain Hospital Clínico Universitario "Lozano Blesa" Zaragoza
United States Retina Consultants of Hawaii, Inc. 'Aiea Hawaii
United States Retina Research Institute of Texas, LLC Abilene Texas
United States Southwest Retina Specialists Amarillo Texas
United States Western Carolina Retinal Associates Asheville North Carolina
United States Retina & Vitreous Center of Southern Oregon, PC Ashland Oregon
United States Southeast Retina Center P.C. Augusta Georgia
United States University of Colorado Aurora Colorado
United States Austin Retina Associates Austin Texas
United States Retina Research of Beaufort Beaufort South Carolina
United States Pacific Northwest Retina Bellevue Washington
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States Retinal Diagnostic Center Campbell California
United States The Retina Group of Washington Chevy Chase Maryland
United States Retina Consultants of Southern CO Colorado Springs Colorado
United States Retina Foundation of the Southwest Dallas Texas
United States Rand Eye Institute Deerfield Beach Florida
United States Retina Group of Florida Fort Lauderdale Florida
United States Eye Medical Center of Fresno Fresno California
United States Retina Consultants of Orange County Fullerton California
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Southeastern Retina Associates, PC Knoxville Tennessee
United States Jacobs Retina Center at The Shiley Eye Institute USCD La Jolla California
United States Colorado Retina Associates, PC Lakewood Colorado
United States Retina Vitreous Surgeons of Central New York Liverpool New York
United States Jules Stein Eye Institute David Geffen School of Medicine Los Angeles California
United States Florida Eye Associates Melbourne Florida
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Ophthalmic Consultants of Long Island Oceanside New York
United States Retina Care Specialists Palm Beach Gardens Florida
United States Doheny Eye Center, UCLA Pasadena California
United States Illinois Eye Center Peoria Illinois
United States Mid Atlantic Retina - Wills Eye Institute Philadelphia Pennsylvania
United States Eye Health Northwest Portland Oregon
United States Retina Northwest PC Portland Oregon
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Retina Consultants of Southern California Redlands California
United States Sierra Eye Associates Reno Nevada
United States Retina Associates of Western NY Rochester New York
United States Retina Vitreous Associates of Florida Saint Petersburg Florida
United States Retina Associates of Utah PC Salt Lake City Utah
United States Orange County Retinal Med Group Santa Ana California
United States Retina Associates of Sarasota Sarasota Florida
United States Retina Center of Texas Southlake Texas
United States Retina Research Institute at New England Retina Springfield Massachusetts
United States East Florida Eye Institute Stuart Florida
United States Southern Vitreoretinal Associates Tallahassee Florida
United States Retina Consultants of Houston The Woodlands Texas
United States Palmetto Retina Center West Columbia South Carolina
United States Associates in Ophthalmology West Mifflin Pennsylvania
United States Vitreo Retinal Consultants & Surgeons Wichita Kansas
United States Strategic Clinical Research Group, LLC Willow Park Texas
United States Center for Retina & Macula Disease Winter Haven Florida
United States Vitreoretinal Associates PC Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Global Development, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Croatia,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Latvia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 should be considered when a participant requires new or additional treatment for that illness.
Up to 18 Months
Secondary Number of participants with Anti-Drug Antibody (ADA) status ADA will be recorded from the serum samples collected. Overall ADA status will be reported: ADA-negative, ADA positive, ADA-inconclusive and unevaluable sample. Up to 18 Months
Secondary Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration Concentration will be recorded from the PK plasma samples collected. Up to 18 Months
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