NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedNeovascular Age-related Macular Degeneration (nAMD)
Date of first enrollment22/11/2023
Target sample size117
Countries of recruitmentUSA,Japan,South Korea,Japan,Australia,Japan
Study typeInterventional
Intervention(s)-KHK4951 eye drop -Aflibercept intraviteral injection (IVT)

Outcome(s)

Primary OutcomeReduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
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
Age maximumNot applicable
GenderBoth
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

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
E-mail 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
E-mail sotaro.takigawa.qv@kyowakirin.com
Affiliation Kyowa Kirin Co., Ltd.