What is KIO-301 studying for late-stage retinitis pigmentosa?

KIO-301 is being studied to assess its safety, tolerability, and effects in adults with late-stage retinitis pigmentosa. Researchers want to understand how multiple doses of this drug given by eye injection impact vision and eye health. This study is sponsored by Kiora Pharmaceuticals, Inc. and aims to provide new information about treatment options for this condition.

Who may be eligible for this late-stage retinitis pigmentosa clinical trial?

Adults aged 18 years or older with a diagnosis of non-syndromic retinitis pigmentosa or Usher's Syndrome Type II may be eligible. Participants must have no light perception or low vision in both eyes and be willing to follow all study procedures. People who are pregnant or breastfeeding are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this late-stage retinitis pigmentosa clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06628947

Phase II Study of Multiple Intravitreal KIO-301 Doses for Safety and Effectiveness in Adults With Late-Stage Retinitis Pigmentosa

Led by Kiora Pharmaceuticals, Inc. · Updated on 2026-06-18

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of up to three doses of KIO-301 given by injection into both eyes every six weeks in adults with late-stage retinitis pigmentosa RP. This study focuses on patients with very limited or no light perception vision, including those classified as No Light Perception or Low Vision. Participants will be randomly assigned to receive either 50 micrograms or 100 micrograms of KIO-301, or a placebo, all administered by intravitreal injection in both eyes three times every six weeks. The main study includes a 12-week treatment period followed by a 12-week follow-up for monitoring. Those who received placebo may opt to join an additional 24-week open-label extension phase. Throughout the study, participants will attend visits every three weeks for safety, tolerability, pharmacokinetic, and efficacy assessments. The screening period can last up to 45 days, and total participation in the main study may last up to 30 weeks, with additional time if joining the extension. Researchers will closely monitor vision changes and side effects to assess the treatments impact and safety.

CONDITIONS

Brief Title

A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Be aged 18 years or older at the time of consent.
Provide informed consent before any study procedures.
Be willing and able to follow all study instructions, attend all visits, and complete assessments.
Have a clinical diagnosis of non-syndromic retinitis pigmentosa or Usher's Syndrome Type II.
Have no light perception in both eyes or low vision with specific visual acuity limits as measured by the Berkeley Rudimentary Vision Test.
Not receive intravitreal corticosteroids or other intravitreal medications from screening until study end.
For low vision participants, pass functional vision tests at specified light levels.
Agree to contraception requirements from screening until three months after last dose if applicable.

You will not qualify if you...

Pregnant, breastfeeding, or planning pregnancy during the study.
Evidence of significant optic nerve disease.
History of one or more retinal detachments.
Clinically significant ocular disease other than RP macular pathologies.
History of high myopia greater than 6 diopters.
Uncontrolled severe glaucoma as defined by specific eye pressure and cup disc ratio.
Previous intraocular surgery except certain cataract surgeries more than 12 months prior.
Aphakia, subluxed intraocular lens, or zonular weakness interfering with vision.
Psychiatric conditions preventing protocol compliance or history of serious mental health issues.
Clinically significant abnormalities in medical history or screening tests.
Any other medical conditions or findings that increase risk or interfere with study participation.
Active ocular or systemic infection or fever at screening.
Recent participation in other investigational studies or exposure to investigational products.
Known or suspected allergy to study drug components.
Use of medications toxic to the retina or optic nerve.

Research Team

Claudia Gregorio-King

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Phase II Study of Multiple Intravitreal KIO-301 Doses for Safety and Effectiveness in Adults With Late-Stage Retinitis Pigmentosa

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria