Condition: OPA1 Gene Mutation · Autosomal Dominant Optic Atrophy · Hereditary Optic Atrophies · Sponsor: PYC Therapeutics
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
This description comes directly from the study's public registry record.
Jessica Stevenson · +61 8 6151 0992 · adoa@pyctx.com
Always discuss trial participation with your own doctor first.
| Save Sight Institute - Sydney Eye Hospital | Sydney, New South Wales, Australia | Recruiting |
| Cerulea Clinical Trials | East Melbourne, Australia | Recruiting |
| Retina Specialists | Auckland, New Zealand | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06970106