A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administered Intravitreally to Patients With Retinitis Pigmentosa and Choroideremia (ABACUS)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
A phase I/II dose-escalating study of the safety, tolerability and efficacy of KIO-301 administered intravitreally to patients with retinitis pigmentosa and choroideremia (ABACUS). Open label.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only).
• Have a visual acuity of:
‣ no light perception for Cohort 3 or
⁃ no light perception or bare light perception for Cohort 1 confirmed with a LogMar \>2.9 using the Berkeley Rudimentary Vision Test (BRVT), or
⁃ count fingers or hand motion for Cohort 2 as confirmed by a LogMar ≤ 2.9 and \> 1.6 using the BRVT.
• Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of \< 0.05 using the BRVT.
Locations
Other Locations
Australia
Royal Adeliade Hospital
RECRUITING
Adelaide
Harley Eye Clinic
RECRUITING
North Adelaide
Contact Information
Primary
Eric Daniels, M.D., MBA
edaniels@kiorapharma.com
61 448787315
Time Frame
Start Date: 2022-11-10
Estimated Completion Date: 2026-07
Participants
Target number of participants: 12
Treatments
Experimental: Patients with Retinitis Pigmentosa and Choroideremia
Related Therapeutic Areas
Sponsors
Leads: Kiora Pharmaceuticals, Inc.