Clinical Trials/NCT06116890

NCT06116890

Active, not recruiting

Phase 2

A Phase 2, Multicenter, Randomized, Double-Masked, Parallel Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Neovascular Age-Related Macular Degeneration

Kyowa Kirin Co., Ltd.84 sites in 3 countries180 target enrollmentJanuary 31, 2024

ConditionsNeovascular Age-Related Macular Degeneration (nAMD)

InterventionsKHK4951 Aflibercept Injection

Overview

Phase: Phase 2
Intervention: KHK4951
Conditions: Neovascular Age-Related Macular Degeneration (nAMD)
Sponsor: Kyowa Kirin Co., Ltd.
Enrollment: 180
Locations: 84
Primary Endpoint: Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
Status: Active, not recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 31, 2024

End Date

September 30, 2026

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyowa Kirin Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Arm B

KHK4951 Middle dose

Intervention: KHK4951

Arm B

KHK4951 Middle dose

Intervention: Aflibercept Injection

Arm C

KHK4951 Low dose

Intervention: KHK4951

Arm C

KHK4951 Low dose

Intervention: Aflibercept Injection

Arm A

KHK4951 High dose

Intervention: KHK4951

Arm A

KHK4951 High dose

Intervention: Aflibercept Injection

Outcomes

Primary Outcomes

Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline

Time Frame: For 44 weeks until the end of the trial

Secondary Outcomes

Change from baseline in MNV lesion area and total MNV leakage area as measured by FA(44 Weeks)
Change from baseline in retinal morphology as measured by SD-OCT(44 weeks)
The number of aflibercept IVT(For 44 weeks until the end of the trial)
Change from baseline in SHRM as measured by SD-OCT(44 weeks)