Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema
ConditionMacular Edema
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorKiora Pharmaceuticals, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be aged 18 to 85 years inclusive at the time of consent.
Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines.
Be willing and able to follow all study instructions, attend all study visits, and complete all study assessments.
Have a clinical diagnosis of ME in the study eye secondary to non-infectious uveitis, retinal vein occlusion, diabetic retinopathy or cataract surgery.
Disqualifiers
Have media opacities (cornea, anterior or posterior synechia, cataract, vitreous haze and others) of either eye that preclude investigation and documentation of the posterior pole and intravenous fluorescein angiography, or optical coherence tomography evaluation in the study eye.
Receive local or systemic biologicals (i.e. tumour necrosis factor [TNF]-blockers, B-cell blockers, cytokines, cytokine-blockers, receptor antagonists) 90 days prior to Day 1 or planned during the study.
Receive treatment with cyclophosphamide or chlorambucil during the study.
Receive intravitreal injections (including but not limited to anti-vascular endothelial growth factors) 90 days prior to Day 1 or planned during the study.
Trial design
Design model
Parallel
Treatments tested in this trial
KIO-104
DrugKIO-104 is an ophthalmic formulation for IVT injection of the active pharmaceutical ingredient (API) KIO-100, a novel, non-steroidal, small molecule inhibitor of dihydroorotate dehydrogenase (DHODH).
Treatment groups
28 Participants
are divided into 4 treatment groupsGroup A: Low Dose KIO-104: 2-weeklyExperimental treatment 1 intervention
Group B: High Dose KIO-104: 2-weeklyExperimental treatment 1 intervention
Group C: Low or High Dose KIO-104: 2-weeklyExperimental treatment 1 intervention
Group D: Low or High Dose KIO-104: 4-weeklyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability
The primary objective is safety and tolerability. The incidence of AEs will be presented by System Organ Class (SOC) and Preferred Term (PT) by dose cohorts.
Time frame
23monthsSponsors and contacts
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Source ClinicalTrials.gov