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Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorOcugen
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv15
  2. Interventions: OCU400 High Dose (Drug), OCU400 Low Dose (Drug), OCU400 Med Dose (Drug) to OCU400 High Dose (Drug), OCU400 Low Dose (Drug), OCU400 Med Dose (Drug), OCU400 Second Eye Dosing (Drug)
    • Study description expanded, about 48 words
    • Study arms: 7 to 8
    • Eligibility criteria expanded, about 2 words
    v14
  3. Primary and study completion dates: Dec 2024 to Mar 2027
    • Study description expanded, about 68 words
    • Publications shortened, about 58 words
    • Study arms: 6 to 7
    v13
  4. Trial status: Recruiting to Active, Not Recruitingv12 Show 4 more changesShow less
    • Enrollment target: estimated 124 to confirmed 22
    • Eligibility criteria expanded, about 270 words
    • Site details revised at 7 of 7 sites
    • Study description expanded, about 4 words
  5. Primary and study completion dates: Feb 2024 to Dec 2024v11
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  1. Eligibility criteria revisedv10
  2. Study sites: 6 to 7v9 Show 5 more changesShow less
    • Interventions: OCU400 (Drug), OCU400 High Dose (Drug), OCU400 Low Dose (Drug), OCU400 Mid Dose (Drug) to OCU400 High Dose (Drug), OCU400 Low Dose (Drug), OCU400 Med Dose (Drug)
    • Eligibility criteria shortened, about 487 words
    • Study description shortened, about 776 words
    • Study arms: 5 to 6
    • Study title shortened, about 1 word
  3. Enrollment target: 24 to 124
    • Study description expanded, about 72 words
    • Study arms: 4 to 5
    v8
  4. Enrollment target: 21 to 24v7 Show 6 more changesShow less
    • Study sites: 7 to 6
    • Primary and study completion dates: Dec 2023 to Feb 2024
    • Interventions: OCU400 High Dose (Drug), OCU400 Low Dose (Drug), OCU400 Mid Dose (Drug) to OCU400 (Drug), OCU400 High Dose (Drug), OCU400 Low Dose (Drug), OCU400 Mid Dose (Drug)
    • Eligibility criteria expanded, about 525 words
    • Study description expanded, about 202 words
    • Study arms: 3 to 4
  5. Primary and study completion dates: Apr 2023 to Dec 2023v6 Show 5 more changesShow less
    • Enrollment target: 18 to 21
    • Eligibility criteria expanded, about 227 words
    • Study description expanded, about 718 words
    • Site details revised at 1 of 7 sites
    • Study title expanded, about 4 words
  6. Eligibility criteria expanded, about 30 wordsv5
  7. Study sites: 8 to 7
    • Eligibility criteria expanded, about 47 words
    v4
  8. Study sites: 1 to 8v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 14, 2022 to Jan 24, 2022
    v2
  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
This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 in patients with retinitis pigmentosa associated with NR2E3 and RHO mutations and in patients with LCA due to mutation(s) in CEP290 gene (OCU400-101). To document prospective eye pathology in the above subjects Investigators will also conduct a Natural History Study (OCU400-104)i This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 24 subjects in the OCU400-101 and 100 subjects in the OCU400-104 study.
Trial Details
NCT Number NCT05203939
Lead Sponsor Ocugen
Conditions
(from sponsor)		 Retinitis Pigmentosa, Leber Congenital Amaurosis
Related terms Enhanced S-Cone Syndrome, Leber Congenital Amaurosis, Meckel Syndrome, Type 4, Night Blindness, Congenital Stationary, Autosomal Dominant 1, Retinitis Pigmentosa
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov