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A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease
Condition: Stargardt Disease · Sponsor: Ocugen
About this study
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. OCU410ST Phase 1- Retinal Structure and Visual Function Data Results * Safety: Favorable safety and tolerability profile No SAE deemed related to OCU410ST including intraocular inflammation, exudation, endophthalmitis, anterior ischemic optic neuropathy (AIONs) or vasculitis. * Primary Endpoint: Structural Improvement Atrophic lesions grew slower by 48% at 12M in evaluable treated eyes when compared to untreated eyes * Secondary Endpoint: Visual Function (BCVA) 100% evaluable treated eyes demonstrated stabilization or improvement when compared to untreated eyes in visual function OCU410ST Phase 1- Structural and Functional Outcomes at 12M Data Results * The GARDian3 clinical trial for ABCA4- related retinopathies including Stargardt disease builds upon encouraging results and positive data from the Phase 1 GARDian trial, which demonstrated 48% slower lesion growth at 12-month follow-up in evaluable treated eyes compared to untreated eyes * Additionally, evaluable treated eyes showed a statistically significant (p=0.031) and clinically meaningful impro…
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (14)
| Associated Retina Consultants | Phoenix, Arizona, United States | — |
| Retinal Consultants Medical Group | Sacramento, California, United States | — |
| Vitreo Retinal Associates, P.A. | Gainesville, Florida, United States | — |
| Bascom Palmer Eye Institute | Miami, Florida, United States | — |
| Advanced Research, LLC | Pompano Beach, Florida, United States | — |
| Retina Partners Midwest, P.C. | Carmel, Indiana, United States | — |
| Boston Children's Hospital | Boston, Massachusetts, United States | — |
| Mississippi Retina Associates | Jackson, Mississippi, United States | — |
| The Retina Institute | St Louis, Missouri, United States | — |
| Duke Eye Center | Durham, North Carolina, United States | — |
| Erie Retina Research, LLC | Erie, Pennsylvania, United States | — |
| Retina Consultants of Texas | Bellaire, Texas, United States | — |
+ 2 more locations — full list on the registry record.
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