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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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.