Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Age-Related Macular Degeneration Clinical Trial

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)

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
• 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
• 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• Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

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