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)

Retinitis Pigmentosa Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282953
• Other study ID #: KIO-301-1101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 10, 2022
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Kiora Pharmaceuticals, Inc.
• Contact: Eric Daniels, M.D., MBA
• Phone: 61 448787315
• Email: edaniels[@]kiorapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). Open label.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only).

2. 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.

3. 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.

Related Conditions & MeSH terms

• Choroideremia
• Retinitis
• Retinitis Pigmentosa

Intervention

Drug:
• KIO-301
KIO-301 intravitreal injection at ascending doses

Locations

Country	Name	City	State
Australia	Royal Adeliade Hospital	Adelaide	South Australia
Australia	Harley Eye Clinic	North Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Kiora Pharmaceuticals, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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