JRCT ID: jRCT2031230401
Registered date:16/10/2023
A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients with Neovascular Age-Related Macular Degeneration
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Neovascular Age-related Macular Degeneration (nAMD) |
Date of first enrollment | 22/11/2023 |
Target sample size | 117 |
Countries of recruitment | USA,Japan,South Korea,Japan,Australia,Japan |
Study type | Interventional |
Intervention(s) | -KHK4951 eye drop -Aflibercept intraviteral injection (IVT) |
Outcome(s)
Primary Outcome | Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline |
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Secondary Outcome | -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 -Number of participants with adverse events -Serum KHK4951 concentration |
Key inclusion & exclusion criteria
Age minimum | >= 50age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 micrometre and <= 450 micrometre at screening |
Exclude criteria | -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 |
Related Information
Primary Sponsor | Takigawa Sotaro |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT06116890 |
Contact
Public contact | |
Name | Clinical trial information contact |
Address | 1-9-2, Otemachi , Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-3-5205-7200 |
clinical.info.jp@kyowakirin.com | |
Affiliation | Kyowa Kirin Co., Ltd. |
Scientific contact | |
Name | Sotaro Takigawa |
Address | 1-9-2, Otemachi , Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-80-4443-5122 |
sotaro.takigawa.qv@kyowakirin.com | |
Affiliation | Kyowa Kirin Co., Ltd. |