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ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis

Study acronym: LIGHTHOUSE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 2 of 21 sites
  2. Secondary endpoints revised (21)
    • Site contacts updated at 1 of 21 sites
  3. Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 19 to 21
    • Study description expanded, about 20 words
    • Site details revised at 4 of 21 sites
  4. Study sites: 19 to 21
    • Study description expanded, about 69 words
    v19
  5. Site details revised at 2 of 19 sitesv18
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  1. Site details revised at 2 of 19 sitesv17
  2. Study sites: 18 to 19v16
  1. Trial sites expanded: 4 → 18 locationsv15
  2. Phase: Phase 1/2 to Phase 3v14 Show 8 more changesShow less
    • Enrollment target: 21 to 97
    • Primary completion date: Oct 2025 to Apr 2028
    • Primary endpoints: 1 to 2
    • Study completion date: Oct 2029 to Apr 2033
    • Eligibility criteria expanded, about 274 words
    • Secondary endpoints: 10 to 19
    • Study description expanded, about 119 words
    • Study arms: 7 to 9
  3. Site contacts updated at 4 of 4 sitesv13
  4. Site contacts updated at 4 of 4 sitesv12
  5. Re-verified, no change to tracked fieldsv11
  6. Enrollment target: 18 to 21
    • Study arms: 6 to 7
    v10
  7. Study sites: 3 to 4v9
  8. Eligibility criteria shortened, about 4 wordsv8
  9. Study sites: 2 to 3v7
  10. Re-verified, no change to tracked fieldsv6
  11. Start date changed from estimate of Aug 2023 to Aug 22, 2023v5
  12. Study sites: 1 to 2
    • Start date: Jul 2023 to Aug 2023
    v4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  14. Secondary endpoints: 9 to 10v2
  15. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will evaluate the safety and efficacy of ATSN-201 in subjects ≥ 5 years of age with RS1-associated X-linked retinoschisis (XLRS).
Trial Details
NCT Number NCT05878860
Lead Sponsor Atsena Therapeutics Inc.
Conditions
(from sponsor)		 X-linked Retinoschisis
Related terms Retinoschisis
Enrollment 97 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov