A Phase 2, Multicenter, Randomized, Double-Masked, Parallel Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Neovascular Age-Related Macular Degeneration

4951-002

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.

2024-01-31

2025-11-01

2025-12-01

Recruiting

Early phase I

180

Inclusion Criteria: * Voluntary written informed consent to participate in the study * Active subfoveal MNV (any subtype) or juxtafoveal MNV secondary to AMD with leakage affecting the fovea in the study eye at screening * BCVA ETDRS letter score of 73 letters to 35 letters in the study eye as measured by the ETDRS visual acuity chart at screening * CST ≥ 350 μm and ≤ 450 μm at screening Exclusion Criteria: * Subretinal hemorrhage, fibrosis, or atrophy of \> 50% of the total lesion area and/or that involves the fovea in the study eye * Uncontrolled glaucoma in the study eye * Aphakia or pseudophakia with AC-IOL in the study eye * Active intraocular inflammation in the study eye * Any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye * History of rhegmatogenous retinal detachment in the study eye * Any current or history of ocular disease other than nAMD in the study eye that may confound assessment of the macula or affect central vision * History of the following therapies in the study eye: * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD * Prior treatment PDT with Visudyne®, external-beam radiation therapy, transpupillary thermotherapy, or panretinal photocoagulation * Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids * Previous intraocular device implantation except PC-IOL * Previous laser (any type) to the macular area * Previous treatment with any IVT anti-VEGF drugs * Any current or history of endophthalmitis in either eye * History of idiopathic or autoimmune-associated uveitis in either eye * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}

2024-05-01