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)
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Patients with Retinitis Pigmentosa
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Drug: KIO-301
KIO-301 intravitreal injection at ascending doses
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Outcome Measures
Primary Outcome Measures
- Number of participants with treatment-related adverse events as assessed by overall changes in retinal thickness and appearance, clinical chemistry and hematology, and other eye assessments. [84 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a clinical diagnosis of retinitis pigmentosa.
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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.
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Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of < 0.05 using the BRVT.
Exclusion Criteria:
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Have evidence of material/substantial optic nerve disease.
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Have a history of retinal detachments.
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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.
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Have high intraocular pressure (IOP) >22 mm Hg.
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Have had a previous intraocular surgery (excluding phakocataract surgery).
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Have aphakia.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kiora Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KIO-301-1101