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 Genders
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

ArmDescriptionAssigned 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

Barnet Dulaney Perkins Eye Center - Phoenix
Mesa, Arizona 85206
Contact:
Jordan Graff

Win Retina
Arcadia, California 91006
Contact:
Peter Win

Retina Vitreous Associates Medical Group
Beverly Hills, California 90211
Contact:
Firas Rahhal

The Retina Partners
Encino, California 91436
Contact:
Hajir Dadgostar

Salehi Retina Institute, Inc
Huntington Beach, California 92647
Contact:
Hani Salehi-Had

Payam Amini
Pasadena, California 91107
Contact:
Payam Amini

Retina Consultants of Southern CO
Colorado Springs, Colorado 80909
Contact:
Cecinio Ronquillo

Blue Ocean Clinical Research West
Clearwater, Florida 33761
Contact:
Dana Deupree

Florida Eye Associates
Melbourne, Florida 32901
Contact:
Vrinda Hershberger

Eye Associates of Pinellas
Pinellas Park, Florida 33782
Contact:
Jason Handza

Ft. Lauderdale Eye Institute
Plantation, Florida 33324
Contact:
Stuart Burgess

Retina Vitreous Associates of Florida - Saint Petersburg
Saint Petersburg, Florida 33711
Contact:
David Eichenbaum

Center for Retina and Macular Disease - Ophthalmology
Winter Haven, Florida 33880
Contact:
Adam Berger

Massachusetts Eye and Ear
Boston, Massachusetts 02114
Contact:
Mohammad Dahrouj

Associated Retinal Consultants (ARC) P.C. - Opthalmology
Royal Oak, Michigan 48073
Contact:
Antonio Capone

Sierra Eye Associates
Reno, Nevada 89502
Contact:
Arshad Khanani

Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico 87109
Contact:
John Pitcher

Retina Vitreous Surgeons of Central NY, PC
Liverpool, New York 13088
Contact:
Jamin Brown

Retina Vitreous Center in Edmond Oklahoma
Edmond, Oklahoma 73013
Contact:
Sandeep Shah

Eye Health Northwest
Portland, Oregon 97225
Contact:
Christopher Aderman

Eye Care Specialists
Kingston, Pennsylvania 18704
Contact:
Erik Kruger

Charleston Neuroscience Institute (RCA Network Site)
Ladson, South Carolina 29456
Contact:
Daniel Alfaro

Charles Retina Institute
Germantown, Tennessee 38138
Contact:
Stephen Huddleston

Retina Research Institute of Texas
Abilene, Texas 79606
Contact:
Sunil Patel

Austin Retina Associates - Ophthalmology/Retina (RCA Network site)
Austin, Texas 78705
Contact:
Robert Wong

Austin Clinical Research, LLC
Austin, Texas 78750
Contact:
Brian Berger

Texas Retina Associates
Fort Worth, Texas 76104
Contact:
Patrick Williams

Retinal Consultants of Texas- San Antonio (RCA Network site)
San Antonio, Texas 78240
Contact:
Richard Lane

Retina Consultants of Texas (RCA Network Site)
The Woodlands, Texas 77384
Contact:
Charles Wykoff

Retina Group of Washington
Fairfax, Virginia 22031
Contact:
Joshua Levinson

More Details

NCT ID
NCT06116890
Status
Recruiting
Sponsor
Kyowa Kirin Co., Ltd.

Study Contact

Kyowa Kirin, Inc.
1-609-919-1100
kkd.clintrial.82@kyowakirin.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center