NCT05282953 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)
| NCT ID | NCT05282953 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Kiora Pharmaceuticals, Inc. |
| Condition | Retinitis Pigmentosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2022-11-10 |
| Primary Completion | 2023-08-10 |
Trial Parameters
Eligibility Fast-Check
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Brief 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).
Eligibility Criteria
Main Study: Inclusion Criteria 1. Be aged 18 to 80 years at Visit 1 of either sex and of any race. 2. Be willing and able to provide informed consent either written, or if the Participant is not able to read, provide consent as stipulated by local laws and Human Research Ethics Committee (HREC) guidelines. 3. Be willing and able to follow all instructions and attend all study visits. 4. Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only). 5. Have a visual acuity of: 1. no light perception for Cohort 3 or 2. no light perception or bare light perception for Cohort 1 confirmed with a LogMar \> 2.9 using the Berkeley Rudimentary Vision Test (BRVT), or 3. count fingers or hand motion for Cohort 2 as confirmed by a LogMar ≤ 2.9 and \> 1.6 using the BRVT. 6. Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of \< 0.05 using the BRVT. 7. Be willing to avoid disallowed medications and treatments for the duration