A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06172257Tipo: INTERVENTIONALInicio: 15 de mar de 2024Fin estimado: 1 de abr de 2026

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).

Descripción detallada

A Phase 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Have a signed informed consent form before any study-specific procedures are performed.
Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus prior to screening (Visit 1).

Criterios de exclusión

Have macular edema considered to be because of a cause other than DME.
Have a decrease in BCVA because of causes other than DME.
Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Intervenciones

drug

Dexamethasone ophthalmic suspension (OCS-01)

Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).

drug

Vehicle

Participants will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).

Ubicaciones

Fundacion Zambrano

Buenos Aires, Buenos Aires, Argentina

Oftalmos - Instituto Oftalmológico de Alta Complejidad

Buenos Aires, Buenos Aires, Argentina

Centro De Ojos Loria Srl

CABA, Buenos Aires, Argentina

Centro Privado de Ojos

CABA, Buenos Aires, Argentina

Organizacion Medica De Investigacion

CABA, Buenos Aires, Argentina

Buenos Aires Macula (BAM) Clinical Research

CABA, Buenos Aires, Argentina

Charles Centro Oftalmológico

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Centro Privado de Ojos Romagosa

Córdoba, Córdoba Province, Argentina

Instituto de Microcirugía Ocular Córdoba (IMOC)

Córdoba, Córdoba Province, Argentina

Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital

Mendoza, Mendoza Province, Argentina

Centro de la Vision Dr. Kolton

Salta, Salta Province, Argentina

Grupo Laser Vision

Rosario, Santa Fe Province, Argentina

Oftalmologìa Global

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalOculis

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