A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients with Neovascular Age-Related Macular Degeneratio
- Conditions
- eovascular Age-related Macular Degeneration (nAMD)
- Registration Number
- JPRN-jRCT2031230401
- Lead Sponsor
- Takigawa Sotaro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 117
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 micrometre and <= 450 micrometre at screening
-Subretinal hemorrhage, fibrosis, or atrophy of > 50 percent 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method