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)

Sponsor

Kiora Pharmaceuticals, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05282953

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

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
Retinitis Pigmentosa	Drug: KIO-301	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with Retinitis Pigmentosa	Drug: KIO-301 KIO-301 intravitreal injection at ascending doses

Arm

Intervention/Treatment

Experimental: Patients with Retinitis Pigmentosa

Drug: KIO-301

KIO-301 intravitreal injection at ascending doses

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

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Have evidence of material/substantial optic nerve disease.
Have a history of retinal detachments.
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.
Have high intraocular pressure (IOP) >22 mm Hg.
Have had a previous intraocular surgery (excluding phakocataract surgery).
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.

Responsible Party:

Kiora Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT05282953

Other Study ID Numbers:

KIO-301-1101

First Posted:

Mar 16, 2022

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinitis

Retinitis Pigmentosa

Study Results

No Results Posted as of Mar 16, 2022