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Active (not recruiting) Phase 2 NCT06116890

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

Phase 2 – studying effectiveness and dosage
Conditions: Neovascular Age-Related Macular Degeneration (nAMD)

Sponsor: Kyowa Kirin Co., Ltd.

trial.available_in: БГ
Overview
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.
Who can participate
Inclusion Criteria: * Voluntary written informed consent to participate in the study * Active subfoveal MNV (any subtype) or juxtafoveal/extrafoveal MNV secondary to AMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) judged by the central reading center at screening * BCVA ETDRS letter score of 78 letters to 35 letters in the study eye as measured by the ETDRS visual acuity chart at screening * CST ≥ 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 * Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 * Previous intraocular device implantation except PC-IOL * Previous laser (any type) to the macular area * Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars; * Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with nAMD within 3 years prior to Day 1 * 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
Locations 4
Australia (1)
Eye Clinic Albury Wodonga
Albury , New South Wales
Japan (1)
Aichi Medical University Hospital - Ophthalmology
Nagakute , Aichi-ken
South Korea (1)
Keimyung University Dongsan Hospital
Daegu , Dalseo-gu
United States (1)
Barnet Dulaney Perkins Eye Center - Phoenix
Mesa , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
50 Years
Healthy volunteers
No
Start date
31.01.2024
Completion date
30.09.2026
Registry ID
NCT06116890
Source
anzctr
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