Testing KIO-301 for patients with Retinitis Pigmentosa and Choroideremia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, and efficacy of KIO-301, administered directly into the eye, for patients diagnosed with retinitis pigmentosa and choroideremia. It is a phase I/II dose-escalating trial, meaning that the dosage of KIO-301 will increase in a controlled manner to assess its effects. The study is open-label, allowing both researchers and participants to know the treatment being administered. The goal is to determine how well this treatment works in improving vision for affected patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only).
2. Have a visual acuity of:

   1. no light perception for Cohort 3 or
   2. no light perception or bare light perception for Cohort 1 confirmed with a LogMar \>2.9 using the Berkeley Rudimentary Vision Test (BRVT), or
   3. count fingers or hand motion for Cohort 2 as confirmed by a LogMar ≤ 2.9 and \> 1.6 using the BRVT.
3. Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of \< 0.05 using the BRVT.

Exclusion Criteria:

1. Have evidence of material/substantial optic nerve disease.
2. Have a history of retinal detachments.
3. Have clinically significant ocular disease (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study or clinically significant opacities of the media.
4. Have high intraocular pressure (IOP) \>22 mm Hg.
5. Have had a previous intraocular surgery (excluding phakocataract surgery).
6. Have aphakia.

Where it's running

• Royal Adeliade Hospital
  Adelaide, South Australia, Australia Recruiting
• Harley Eye Clinic
  North Adelaide, South Australia, Australia Recruiting

Study contacts

• Principal investigator: Robert Casson — Royal Adelaide Hospital
• Study coordinator: Eric Daniels, M.D., MBA
• Email: edaniels@kiorapharma.com
• Phone: 61 448787315

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.