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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05282953
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