Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

Purpose

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

Condition

  • Diabetic Macular Edema (DME)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Voluntary written informed consent to participate in the study - In Korea, participants must be 19 years or older to be enrolled - BCVA ETDRS letter score of 78 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening - 500 μm ≥ CST ≥ 325 μm in the study eye at screening - HbA1c ≤ 11% at screening

Exclusion Criteria

  • Any signs of proliferative diabetic retinopathy in the study eye - History of rubeosis 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 DME that may confound assessment of the macula or affect central vision in the study eye - History of the following therapies in the study eye - History of vitrectomy surgery, submacular surgery, or other surgical intervention for DME - Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids - Previous intraocular device implantation except PC-IOL - Laser (any type) to the macular area within 12 weeks prior to Day 1 - Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1 - 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 - Previous use of Ozurdex® or Iluvien® implant - 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 36 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 36 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 36 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

California Eye Specialists Medical Group Inc
Pasadena, California 91107
Contact:
Payam Amini

Retina Consultants of Southern California
Redlands, California 92374
Contact:
John Carlson

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

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

Southern Vitreoretinal Associates
Tallahassee, Florida 32308
Contact:
Robert Steinmetz

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

Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland 21740
Contact:
Adam Gerstenblith

Sierra Eye Associates
Reno, Nevada 89502
Contact:
Arshad Khanani

Envision Ocular, LLC
Bloomfield, New Jersey 07003
Contact:
Patrick Higgins

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

EyeHealth Northwest
Portland, Oregon 97225
Contact:
Christopher Aderman

Wills Eye Health System
Bethlehem, Pennsylvania 18017
Contact:
Yoshihiro Yonekawa

Eye Care Specialists
Kingston, Pennsylvania 18704
Contact:
Erik Kruger

Retina Consultants of Charleston - (RCA Network Site)
Charleston, South Carolina 29414
Contact:
John Kerrison

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

Black Hills Regional Eye Institute - Ophthalmology
Rapid City, South Dakota 57701
Contact:
Prema Abraham

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:
Fuad Makkouk

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

Strategic Clinical Research Group, LLC
Willow Park, Texas 76087
Contact:
Seong Lee

Retina Group of Washington
Fairfax, Virginia 22031
Contact:
Jordana Goren Fein

More Details

NCT ID
NCT06116916
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