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)

Kiora Pharmaceuticals, Inc.3 sites in 1 country48 target enrollmentNovember 10, 2022

InterventionsKIO-301

DrugsKIO-301

Overview

Phase: Phase 1
Intervention: KIO-301
Conditions: Not specified
Sponsor: Kiora Pharmaceuticals, Inc.
Enrollment: 48
Locations: 3
Primary Endpoint: Main Study Primary Outcome Measure
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Detailed Description

Main Study: assesses the safety and tolerability of single doses of KIO-301 when administered intravitreally to participants with retinitis pigmentosa and choroideremia. Sub-study: determines the test/re-test reliability of functional vision assessments in participants with low visual acuity.

Registry

clinicaltrials.gov

Start Date

November 10, 2022

End Date

July 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kiora Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Patients with Retinitis Pigmentosa and Choroideremia

Intervention: KIO-301

Outcomes

Primary Outcomes

Main Study Primary Outcome Measure

Time Frame: 84 days.

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.