Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration
- Conditions
- Neovascular Age-Related Macular Degeneration (nAMD)
- Registration Number
- NCT06116890
- Lead Sponsor
- Kyowa Kirin, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria:<br><br> - Voluntary written informed consent to participate in the study<br><br> - Active subfoveal MNV (any subtype) or juxtafoveal MNV secondary to AMD with leakage<br> affecting the fovea in the study eye at screening<br><br> - BCVA ETDRS letter score of 73 letters to 35 letters in the study eye as measured by<br> the ETDRS visual acuity chart at screening<br><br> - CST = 350 µm and = 450 µm at screening<br><br>Exclusion Criteria:<br><br> - Subretinal hemorrhage, fibrosis, or atrophy of > 50% of the total lesion area and/or<br> that involves the fovea in the study eye<br><br> - Uncontrolled glaucoma in the study eye<br><br> - Aphakia or pseudophakia with AC-IOL in the study eye<br><br> - Active intraocular inflammation in the study eye<br><br> - Any current ocular condition for which visual acuity loss would not improve from<br> resolution of macular edema in the study eye<br><br> - History of rhegmatogenous retinal detachment in the study eye<br><br> - Any current or history of ocular disease other than nAMD in the study eye that may<br> confound assessment of the macula or affect central vision<br><br> - History of the following therapies in the study eye:<br><br> - History of vitrectomy surgery, submacular surgery, or other surgical<br> intervention for AMD<br><br> - Prior treatment PDT with Visudyne®, external-beam radiation therapy,<br> transpupillary thermotherapy, or panretinal photocoagulation<br><br> - Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids<br><br> - Previous intraocular device implantation except PC-IOL<br><br> - Previous laser (any type) to the macular area<br><br> - Previous treatment with any IVT anti-VEGF drugs<br><br> - Any current or history of endophthalmitis in either eye<br><br> - History of idiopathic or autoimmune-associated uveitis in either eye<br><br> - Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either<br> eye
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
- Secondary Outcome Measures
Name Time Method The number of aflibercept IVT;Change from baseline in SHRM as measured by SD-OCT;Change from baseline in retinal morphology as measured by SD-OCT;Change from baseline in MNV lesion area and total MNV leakage area as measured by FA