RECRUITING

A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease

Description

Phase 2/3 Pivotal Confirmatory Clinical Trial is a randomized, outcome assessor-masked, multicenter study, that will enroll fifty-one (51) subjects. Subjects will be enrolled in a 2:1 ratio to either the treatment group (n=34 subjects) or to an untreated control group (n=17 subjects). Phase 1 is complete and closed for enrollment. It was a multicenter, open-label, dose ranging/dose escalation study that enrolled 9 subjects.

Study Overview

Study Details

Study overview

Phase 2/3 Pivotal Confirmatory Clinical Trial is a randomized, outcome assessor-masked, multicenter study, that will enroll fifty-one (51) subjects. Subjects will be enrolled in a 2:1 ratio to either the treatment group (n=34 subjects) or to an untreated control group (n=17 subjects). Phase 1 is complete and closed for enrollment. It was a multicenter, open-label, dose ranging/dose escalation study that enrolled 9 subjects.

A PHASE 1 STUDY TO ASSESS THE SAFETY AND EFFICACY OF OCU410ST FOR STARGARDT DISEASE AND PHASE 2/3 PIVOTAL CONFIRMATORY CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF OCU410ST FOR STARGARDT DISEASE

A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease

Condition
Stargardt Disease
Intervention / Treatment

-

Contacts and Locations

Phoenix

Associated Retina Consultants, Phoenix, Arizona, United States, 85020

Gainesville

Vitreo Retinal Associates, P.A., Gainesville, Florida, United States, 32607

Miami

Bascom Palmer Eye Institute, Miami, Florida, United States, 33136

Pompano Beach

Advanced Research, LLC, Pompano Beach, Florida, United States, 33064

Carmel

Retina Partners Midwest, P.C., Carmel, Indiana, United States, 46032

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Jackson

Mississippi Retina Associates, Jackson, Mississippi, United States, 39202

Saint Louis

The Retina Institute, Saint Louis, Missouri, United States, 63128

Durham

Duke Eye Center, Durham, North Carolina, United States, 27710

Erie

Erie Retina Research, LLC, Erie, Pennsylvania, United States, 16505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    5 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Ocugen,

    Murthy Chavali, MD, Ph.D., STUDY_DIRECTOR, Ocugen., Inc.

    Study Record Dates

    2026-09-28