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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 03 Oct 2025

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At a glance

  • Drugs OCU 410 ST (Primary)
  • Indications Cone rod dystrophies; Retinitis pigmentosa; Stargardt disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms GARDian; GARDian3
  • Sponsors Ocugen

Most Recent Events

  • 13 Aug 2025 According to an Ocugen media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for Stargardt disease and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA).
  • 29 Jul 2025 Protocol has been amended with change in Phase, endpoints and patient number.
  • 29 Jul 2025 Planned number of patients changed from 42 to 51.

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