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

← catalyst calendar

NCT05956626 · readout in 40 d

Sponsored by Ocugen (industry) · OCGN — their whole pipeline →.

Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
51estimated
Sites
14
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-08-25actualWhen the study began enrolling
Primary completion2026-09-28estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-09-28estimatedThe whole study's end, after follow-up
First posted2023-07-21actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-31actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Stargardt Disease

Intervention

  • Drug: OCU410ST

Primary outcomes

what the primary-completion date above is the date OF
Change from baseline in atrophic lesion size as measured by Fundus Auto Fluorescence
measured 12 months (Screening to 12 months post OCU410ST administration)
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events))
measured 12 months (Screening to 12 months post OCU410ST administration)

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