RecruitingPhase 2NCT06628947

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

A Phase II, Randomised, Controlled, Double Masked, Multiple Dose Study of the Safety, Tolerability and Efficacy of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa

Sponsor

Kiora Pharmaceuticals, Inc.

Enrollment

36 participants

Start Date

Aug 29, 2025

Study Type

INTERVENTIONAL

Conditions

Retinitis Pigmentosa

Summary

The goal of the study is to investigate the safety, tolerability and efficacy of up to 3 doses of KIO-301 administered by intravitreal (IVT) injection bilaterally every 6 weeks in patients with late-stage retinitis pigmentosa (RP). Late-stage RP patients will include those patients with No Light Perception (NLP), or Low Vision (LV).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 100 μg KIO-301, a drug called 50 μg KIO-301, and others for people with retinitis pigmentosa. The study is currently recruiting participants at 5 locations.

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

OTHERPlacebo (Sterile Saline or Balanced Salt Solution)

A control 50 μl injection of clear sterile saline or balanced salt solution (BSS) liquid.

DRUG100 μg KIO-301

KIO-301 drug product is an ophthalmic formulation of the drug substance KIO-300-Cl in sulfobutylether-β-cyclodextrin, sucrose, phosphate buffer salts and water suitable for IVT injection. The drug substance KIO-300-Cl is a quaternary ammonium chloride salt of the active compound KIO-300.

DRUG50 μg KIO-301