A Phase 2, Double-masked, Randomized, Sham-controlled, Multiple-dose Study of the Efficacy and Safety of Intravitreal KUS121 in the Treatment of Non-Arteritic Central Retinal Artery Occlusion (CRAO)

KDK-1101-02

Central retinal artery occlusion (CRAO) is an ophthalmologic emergency which leads to severe and permanent vision loss. There is no evidence-based therapy for CRAO. The objective of this GION study is to evaluate the efficacy and safety of KUS121 intravitreal (IVT) injection in participants with acute non-arteritic CRAO.

2024-04-16

2024-12-01

2025-09-01

Recruiting

Early phase I

75

Inclusion Criteria: * Participants who are willing and able to comply with clinic visits and study-related procedures and able to provide signed informed consent in person or from their legally authorized representative * Males and females ≥ 20 years of age at that time of providing signed informed consent * Diagnosed as non-arteritic Central Retinal Artery Occlusion from 3 hours until no more than 48 hours after the onset of significant visual acuity changes * Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 0 to 35 in the study eye at screening prior to enrollment (eyes with 'no light perception' or 'light perception' are to be excluded) * Retinal thickening or hyper-reflectivity in retinal inner layers in spectral domain optical coherence tomography (SD-OCT), or white turbid edema in fundus examination Exclusion Criteria: * Presence of the following conditions in the study eye: 1. Infection in or around the eye 2. Uncontrolled intraocular pressure 3. Abnormality in macula other than CRAO findings 4. History of macular photocoagulation 5. Opacity in visual axis preventing fundus examination or fundus imaging (e.g., corneal dystrophy) 6. Neovascularization of iris and retina 7. Any inflammatory disease involving the eye 8. Optic atrophy 9. Glaucomatous cupping greater than 0.9 10. Prior vitrectomy 11. Aphakia with the absence of posterior capsule 12. Any IVT injection or sub-Tenon's injection within 1 month of screening 13. Any intraocular surgery or ocular implant within 3 months of screening 14. Any history of ocular trauma within 3 months of screening * Thrombolytic, fibrinolytic or prostaglandin E1 systemic treatment within 1 month of screening * A positive urine pregnancy test on Day 1 prior to study enrollment * History of allergy or hypersensitivity to KUS121 or a compound with a condensed polycyclic aromatic hydrocarbon skeleton represented by naphthalene and any of excipients of KUS121 product, fluorescein, or any study treatment-related mandatory ingredients that is not amenable to treatment * Known hypersensitivity to a study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study * Presence of other medical disease, physical or ocular examination finding, or clinical laboratory finding that in the opinion of the Investigator contraindicates the use of an investigational product, might interfere with the evaluation of the efficacy or safety of the study drug, may put the participant at significant risk or might interfere with the participant's ability to participate in the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

2024-04-22