Actively Recruiting
A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa
Led by Kiora Pharmaceuticals, Inc. · Updated on 2026-04-30
36
Participants Needed
5
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa
Who Can Participate
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 attend all study visits and complete assessments.
- Have a clinical diagnosis of non-syndromic retinitis pigmentosa, including Usher's Syndrome Type II.
- Have vision classified as no light perception or low vision in both eyes as per study vision tests.
- Not receive intravitreal medications other than corticosteroids from screening until study end.
- For low vision participants, pass specified multi-luminance functional vision tests at certain light levels.
- Agree to follow contraception requirements from screening until three months after last dose of study drug, with specific conditions based on sex and reproductive potential.
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.
- Have other significant eye diseases or opacities that interfere with study assessments.
- History of high myopia greater than 6 diopters.
- Have uncontrolled severe glaucoma despite medication.
- Previous eye surgery except certain cataract surgeries more than 12 months prior.
- Aphakia, subluxed intraocular lens, or zonular weakness causing light obstruction.
- Psychiatric conditions that affect study compliance or recent history of severe mental health issues.
- Significant abnormal medical findings that interfere with participation.
- Active infections or fever at screening.
- Recent participation in other investigational studies or use of investigational products.
- Known allergies to study drug components.
- Taking medications toxic to the retina or optic nerve.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Save Sight Institute
Sydney, New South Wales, Australia, 2000
Actively Recruiting
2
Queensland Eye Institute
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
4
Cerulea Clinical Trials
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
5
Lions Eye Institute
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
C
Claudia Gregorio-King
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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