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