Actively Recruiting
Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema
Led by Kiora Pharmaceuticals, Inc. · Updated on 2026-04-30
28
Participants Needed
4
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, open label study to assess the safety, tolerability, and efficacy of KIO-104 administered by IVT injection to the study eye of eligible participants with macular edema.
CONDITIONS
Official Title
Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be aged 18 to 85 years inclusive at the time of consent.
- Provide informed consent prior to any study procedures.
- Be willing and able to follow all study instructions, attend all study visits, and complete all study assessments.
- Have a clinical diagnosis of macular edema in the study eye secondary to non-infectious uveitis, retinal vein occlusion, diabetic retinopathy, or cataract surgery.
- If currently receiving systemic corticosteroid or immunosuppressive therapy, be on a stable dose for at least 3 months prior to screening and during the study.
- Have a Central Subfield Thickness (CST) of 65 350 bcm.
- Have a Best Corrected Visual Acuity (BCVA) in the study eye of 64 20/32 (Feet); logMAR 65 0.2 and 65 20/800 (Feet); logMAR 64 1.6.
- Have media clarity and pupillary dilation sufficient for adequate visualization and assessment of the study eye.
- Be willing to avoid disallowed medications and treatments for the duration of the study.
- Agree to follow appropriate contraception requirements from screening until 3 months after the last dose of study drug if applicable.
You will not qualify if you...
- Have media opacities of either eye that prevent proper eye examination or imaging in the study eye.
- Have received local or systemic biological treatments (e.g., TNF-blockers, B-cell blockers) within 90 days prior to Day 1 or planned during the study.
- Have received treatment with cyclophosphamide or chlorambucil during the study.
- Have had intravitreal injections within 90 days prior to Day 1 or planned during the study.
- Have had posterior subtenon's or orbital floor steroid injections within 90 days prior to Day 1 or planned during the study.
- Have implantable corticosteroid-eluting devices in the study eye unless removed or implanted beyond specified timeframes.
- 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 during the study.
- Have intraocular pressure 65 25 mmHg in the study eye, except glaucoma patients controlled with one medication.
- Have ocular hypotony (IOP < 6 mmHg).
- Have aphakia or anterior chamber lens in the study eye.
- Have visible scleral thinning, scleral ectasia, or keratoconus in the study eye.
- Have any ocular malignancy in either eye.
- Have other significant ocular diseases that interfere with assessments.
- Have ocular or systemic infection or fever >38.06C or recent antibiotic use within 14 days of Day 1.
- Have psychiatric conditions that interfere with compliance, including recent history of suicide plan.
- Have clinically significant abnormalities that interfere with study or participation.
- Have other medical conditions or co-morbidities that increase risk or interfere with study.
- Have participated in other investigational trials within 90 days prior to Day 1 or during the study.
- Receive anticoagulants or platelet inhibitors within 14 days prior to Day 1 or planned during the study.
- Have known allergy or hypersensitivity to study medication, delivery vehicle, corticosteroids, diagnostic agents used, or other standard care medications.
- Are pregnant, breastfeeding, or planning pregnancy during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
C
Claudia Gregorio-King
CONTACT
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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