RecruitingPhase 1Phase 2NCT05282953

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)


Sponsor

Kiora Pharmaceuticals, Inc.

Enrollment

48 participants

Start Date

Nov 10, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new eye injection (KIO-301) to see if it can help restore some light perception in people with advanced retinitis pigmentosa (RP) or choroideremia — inherited eye diseases that progressively destroy vision. The drug works by making surviving retinal cells sensitive to light in a new way. You may be eligible if: - You are between 18 and 80 years old - You have a confirmed diagnosis of retinitis pigmentosa or choroideremia - You have very limited vision (ranging from no light perception to hand motion vision, depending on the study group) - Both eyes have similar levels of vision - You are willing to use contraception and follow study requirements You may NOT be eligible if: - You have significant optic nerve disease - You have a history of retinal detachment - You have other significant eye diseases (e.g., severe dry eye, uveitis, corneal swelling) - Your eye pressure is above 22 mm Hg - You have had previous intraocular surgery (other than cataract surgery) - You have a pacemaker, cochlear implant, intracranial aneurysm clips, or other metal implants in your body - You have a significant psychiatric condition - You have active infection or fever Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKIO-301

KIO-301 intravitreal injection at ascending doses


Locations(3)

Save Sight Institute

Sydney, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Harley Eye Clinic

North Adelaide, South Australia, Australia

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NCT05282953


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