A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD

TerminadoFase 3ClinicalTrials.gov

ID: NCT04757636RENIS: IS003600Tipo: INTERVENTIONALInicio: 12 de mar de 2021Fin estimado: 31 de mar de 2025

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Resumen

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.

Criterios de exclusión

Any previous treatment for neovascular AMD.
Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

Intervenciones

biological

2.0 mg OPT-302

intravitreal injection

biological

2.0 aflibercept

intravitreal injection

procedure

Sham

intravitreal injection

Ubicaciones

COAST Investigational Site

Rosario, Santa Fe Province, Argentina

COAST Investigational Site

Rosario, Sante Fe, Argentina

COAST Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

COAST Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

COAST Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

COAST Investigational Site

Mendoza, Argentina

Patrocinadores

PrincipalOpthea Limited

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