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

Study acronym: GARDian3
StatusActive, Not Recruiting
PhasePhase 2/3
SponsorOcugen
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 31, 2026 (before its estimated September 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv12
  2. Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria expanded, about 13 words
    • Site details revised at 14 of 14 sites
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Study sites: 13 to 14v9
  5. Phase: Phase 1/2 to Phase 2/3v8 Show 10 more changesShow less
    • Primary and study completion dates: Oct 28, 2025 to Sep 28, 2026
    • Primary endpoints: 6 to 2
    • Enrollment target: 42 to 51
    • Study sites: 6 to 13
    • Interventions: OCU410ST (Genetic) to OCU410ST (Drug)
    • Eligibility criteria shortened, about 30 words
    • Secondary endpoints: 4 to 2
    • Study description expanded, about 193 words
    • Study arms: 9 to 2
    • Study title expanded, about 3 words
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Study sites: 3 to 6v6
  3. Study sites: 2 to 3v5
  4. Primary and study completion dates: Dec 15, 2025 to Oct 28, 2025v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Oct 15, 2025 to Dec 15, 2025
    • Study completion date: Nov 15, 2025 to Dec 15, 2025
    • Start date changed from estimate of Jul 15, 2023 to Aug 25, 2023
    • Eligibility criteria shortened, about 1,498 words
    • Secondary endpoints: 3 to 4
    • Study description shortened, about 970 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ocugen
6 trials monitored
See all monitored trials
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 improvement of nearly 2-line/9-letter gain in best corrected visual acuity (BCVA) at 12-month follow-up when compared to untreated eyes.
Trial Details
NCT Number NCT05956626
Lead Sponsor Ocugen
Conditions
(from sponsor)		 Stargardt Disease
Related terms Stargardt Disease
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov