Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Astellas Pharma Global Development, Inc. (Voir sur ClinicalTrials)
septembre 2022
mars 2025
13 juillet 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Eric SOUIED | 29/03/2024 01:30:35 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Yannick LE MER | 21/06/2024 13:34:56 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre D'exploration Ophtalmologique De L'odéon - 75006 - Paris - France | Contact (sur clinicalTrials) | ||||
| Centre d'Imagerie et Laser - 75015 - Paris - France | Contact (sur clinicalTrials) | ||||
| Centre Ophtalmologique Rabelais - 69002 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Ophtalmologique Saint Exupéry - 37540 - Saint Cyr sur Loire - France | Contact (sur clinicalTrials) | ||||
| Centre Paradis-Monticelli - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Croix-Rousse - 69317 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Pole Vision Val D'Ouest - 69130 - Ecully - France | Contact (sur clinicalTrials) | ||||
| Rothschild Foundation - 75019 - Paris - France | Contact (sur clinicalTrials) | ||||
| University Hospital of Bordeaux - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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