Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Kirin, Inc.
• Treatments: Aflibercept

Criteria

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