A new small molecule DHODH-inhibitor [KIO-100 (PP-001)] targeting activated T cells for intraocular treatment of uveitis - A phase I clinical trial.
Stephan Thurau, Christoph M E Deuter, Arnd Heiligenhaus...
https://pubmed.ncbi.nlm.nih.gov/36325389Actively Recruiting
Phase 2
Age: 18Years - 85Years
All Genders
ID06825702
A Phase 2, Open-label, Multiple Dose Study of the Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema (KLARITY-1)
Led by Kiora Pharmaceuticals, Inc. · Updated on 2026-04-30
28
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of KIO-104 in people with macular edema. This is an open-label, multi-center study focusing on participants aged 18 to 85 years who have macular edema caused by conditions such as non-infectious uveitis, retinal vein occlusion, diabetic retinopathy, or cataract surgery. The study aims to better understand how well KIO-104 works and how safe it is when injected directly into the eye. The study is divided into two parts. In Part A, participants receive up to three doses of KIO-104 injected into the study eye every two weeks, testing two dose levels: low and high. In Part B, participants receive up to three doses with either a two-week or four-week interval between injections, using the dose selected from Part A. The treatment groups include low dose every two weeks, high dose every two weeks, and either dose every four weeks. Participants will attend study visits to receive the injections and undergo various eye assessments, including measuring central subfield thickness and visual acuity. Researchers will monitor safety and tolerability for up to 23 months. Participants must follow study instructions, avoid certain medications, and agree to contraception requirements during and after the study. The study includes regular evaluations to assess the effects of KIO-104 on macular edema and overall eye health.
CONDITIONS
Brief Title
Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Be aged 18 to 85 years inclusive at the time of consent.
- Provide informed consent before any study procedures.
- Be willing and able to follow all study instructions, attend all visits, and complete assessments.
- Have a clinical diagnosis of macular edema in the study eye due to non-infectious uveitis, retinal vein occlusion, diabetic retinopathy, or cataract surgery.
- If on systemic corticosteroid or immunosuppressive therapy, be on a stable dose for at least 3 months prior and during the study.
- Have a Central Subfield Thickness (CST) of 350 µm or more.
- Have Best Corrected Visual Acuity (BCVA) in the study eye between 20/32 and 20/800 (logMAR 0.2 to 1.6).
- Have clear media and sufficient pupil dilation for eye assessment.
- Be willing to avoid disallowed medications and treatments during the study.
- Agree to contraception requirements from screening until 3 months after last dose, including pregnancy testing and use of birth control as applicable.
You will not qualify if you...
- Have eye media opacities that prevent proper examination or imaging of the study eye.
- Have received local or systemic biological therapies within 90 days prior to Day 1 or planned during the study.
- Have received cyclophosphamide or chlorambucil during the study.
- Have received intravitreal injections or steroid injections near the eye within 90 days prior to Day 1 or planned during the study.
- Have implantable corticosteroid devices in the study eye unless removed or implanted long before Day 1 according to specified timelines.
- Have had ocular surgery in the study eye within 90 days prior to Day 1 or planned during the study.
- Have had capsulotomy in the study eye within 30 days prior to Day 1 or planned during the study.
- Have intraocular pressure (IOP) 25 mmHg or higher, except glaucoma patients controlled with one medication.
- Have ocular hypotony (IOP below 6 mmHg).
- Have aphakia or anterior chamber lens in the study eye.
- Have visible scleral thinning, ectasia, or keratoconus in the study eye.
- Have any ocular malignancy in either eye.
- Have other significant ocular diseases affecting assessments.
- Have ocular or systemic infection, fever over 38.0°C, or recent antibiotic use.
- Have psychiatric conditions affecting study compliance or history of suicide plan within 5 years.
- Have clinically significant abnormalities or medical conditions interfering with study participation.
- Have participated in other investigational trials within 90 days prior to Day 1 or planned during the study.
- Receive anticoagulant or platelet aggregation inhibitors within 14 days prior to Day 1 or planned during the study.
- Have allergies to study medication components or related medications.
- Are pregnant, breastfeeding, or plan to become pregnant during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 weeks for 2-weekly dosing or up to 8 weeks for 4-weekly dosing
Participants receive up to three doses of KIO-104 administered to the study eye. Dosing schedules vary by cohort, with injections given every 2 weeks or every 4 weeks depending on cohort assignment.
3 dosing visits (in-person) plus any additional assessment visits
Follow-up
Duration - Up to 23 months
Participants are monitored for safety and efficacy after the last dose of KIO-104 for up to 23 months.
Periodic visits during follow-up
Trial Site Locations
Total: 4 locations
1
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2001
Actively Recruiting
2
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
3
Centre for Eye Research Australia
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
4
Lions Eye Institute Limited
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
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Research Team
C
Claudia Gregorio-King
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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