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RECRUITING
NCT06628947
PHASE2

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

Sponsor: Kiora Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-08-29

Completion Date

2027-08

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

OTHER

Placebo (Sterile Saline or Balanced Salt Solution)

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

DRUG

100 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.

DRUG

50 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.

Locations (5)

Save Sight Institute

Sydney, New South Wales, Australia

Queensland Eye Institute

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Cerulea Clinical Trials

East Melbourne, Victoria, Australia

Lions Eye Institute

Nedlands, Western Australia, Australia