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

NCT06628947 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-30

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • Kiora Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Doron Hickey, MBChB · The Centre for Eye Research Australia (CERA)

  • Robert Casson, MBBS (Hons) · Royal Adelaide Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-29
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06628947 on ClinicalTrials.gov