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)

Launched by KIORA PHARMACEUTICALS, INC. · Mar 15, 2022

Keywords

ClinConnect Summary

The ABACUS trial is a study looking at a new treatment called KIO-301 for patients with two specific eye conditions: retinitis pigmentosa and choroideremia. The main goal is to find out if this treatment is safe and how well it works when given directly into the eye (a method known as intravitreal injection). This study is currently recruiting participants aged between 65 and 74 years and those younger than 29 years. To qualify, participants must have a clinical diagnosis of either condition and specific types of vision impairment. For example, some must have no light perception, while others can see only hand movements.

If you choose to participate, you'll receive the KIO-301 treatment and be monitored closely by the study team for any side effects or changes in your vision. It's important to know that there are some restrictions for joining, such as not having significant optic nerve disease or certain other eye conditions that might interfere with the study. This trial represents a hopeful step forward for those affected by these eye diseases, as it aims to explore a potential new option for improving vision.

Gender

ALL

Eligibility criteria

• 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.