An Open-label Extension (OLE) Phase 3 Trial to Assess the... | EligiMed

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)

CompletadoFase 3ClinicalTrials.gov

ID: NCT05536297Tipo: INTERVENTIONALInicio: 26 de sept de 2022Fin estimado: 10 de abr de 2025

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

Intervenciones

drug

avacincaptad pegol

Intravitreal Injection

Ubicaciones

Oftalmólogos Especialistas

Rosario, Sante Fe, Argentina

Centro Oftalmológico Dr. Charles

Buenos Aires, Argentina

Instituto Oftalmologico de Buenos Aires

Buenos Aires, Argentina

Oftar Mendoza

Mendoza, Argentina

Microcirugia Ocular

Santa Fe, Argentina

Patrocinadores

PrincipalAstellas Pharma Global Development, Inc.

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