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

Purpose

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.

Condition

Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility

Eligible Ages: Over 50 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm A	KHK4951 High dose	Drug: KHK4951 KHK4951 eye drop for 44 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Experimental Arm B	KHK4951 Middle dose	Drug: KHK4951 KHK4951 eye drop for 44 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Experimental Arm C	KHK4951 Low dose	Drug: KHK4951 KHK4951 eye drop for 44 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Recruiting Locations

More Details

NCT ID: NCT06116890
Status: Active, not recruiting
Sponsor: Kyowa Kirin Co., Ltd.