A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of Small Molecule KIO-301 Administered Intravitreally to Patient s With Retinitis Pigmentosa (ABACUS)

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase I/II dose-escalating study of the safety, tolerability and efficacy of small molecule KIO-301 administered intravitreally to patient s with retinitis pigmentosa (ABACUS) . Open label.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kiora Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Have a clinical diagnosis of retinitis pigmentosa.

• Have a visual acuity of no light perception or bare light perception for Cohort 1 confirmed with a LogMar >3 using the Berkeley Rudimentary Vision Test (BRVT), and have a visual acuity of count fingers or hand motion as confirmed by a LogMar < 3.0 and > 1.6 using the BRVT for Cohort 2.

• Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of < 0.05 using the BRVT.

Exclusion Criteria:

1. Have evidence of material/substantial optic nerve disease.

2. Have a history of retinal detachments.

3. Have clinically significant ocular disease (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study or clinically significant opacities of the media.

4. Have high intraocular pressure (IOP) >22 mm Hg.

5. Have had a previous intraocular surgery (excluding phakocataract surgery).

6. Have aphakia.