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Safety of Single and Repeat Dose of PYC-001 Eye Injections in People With Autosomal Dominant Optic Atrophy (Myrtle)

Study acronym: PYC-001-CL-102
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion pushed from Dec 1, 2027 to Oct 2029
    • Enrollment increased: 18 → 24 participants
    • Study completion pushed from Jan 1, 2028 to Nov 2029
    • Secondary endpoints: details revised at 11 of 11 entries
    v9
  2. Primary completion pushed from Dec 1, 2026 to Dec 1, 2027v8 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reduced: 21 → 18 participants
    • Study completion pushed from Jan 1, 2027 to Jan 1, 2028
    • Trial arms changed: 7 → 6
    • Eligibility criteria shortened, about 827 words
    • Secondary endpoints: 29 to 11
    • Study description shortened, about 37 words
    • Study title expanded, about 1 word
  3. Study sites: 2 to 3v7
  4. Re-verified, no change to tracked fieldsv6
  5. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Start date: Sep 1, 2025 to Sep 30, 2025
    • Secondary endpoints revised (29)
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 3 words
Show 3 earlier versionsHide 3 earlier versions
  1. Site contacts updated at 2 of 2 sitesv4
  2. Re-verified, no change to tracked fieldsv3
  3. Start date: Jun 1, 2025 to Sep 1, 2025v2 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints revised (29)
    • Primary endpoints revised (18)
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study aims to gather safety data and determine the optimal dosing regimen for PYC-001 in participants with confirmed OPA1 mutation-associated ADOA. Approximately 18 participants from Australia, New Zealand, and other APAC countries are expected to be enrolled, depending on safety review committee (SRC) throughout the course of the study. Participants may be assigned to any of the following: 1. A single 60ug dose of PYC-001 2. Three doses of 10ug PYC-001 at an interval of 8 weeks 3. Three doses of 10ug PYC-001 at an interval of 12 weeks 4. Three doses of 30ug PYC-001 at an interval of 8 weeks 5. Three doses of 30ug PYC-001 at an interval of 12 weeks Following completion of the 4 week safety review of the single 60ug of PYC-001 cohort, and if the 60 μg dose level is deemed safe by the SRC, the following cohorts will also be available: 6. Three doses of 60ug PYC-001 at an interval of 12 weeks
Trial Details
NCT Number NCT06970106
Lead Sponsor PYC Therapeutics
Conditions
(from sponsor)		 OPA1 Gene Mutation, Autosomal Dominant Optic Atrophy, Hereditary Optic Atrophies, Kjer Optic Atrophy
Related terms Optic Atrophies, Hereditary, Optic Atrophy, Autosomal Dominant
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov