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

April 8, 2024 updated by: Kyowa Kirin, Inc.

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 Diabetic Macular Edema

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 02640
        • Not yet recruiting
        • Eye Clinic Albury Wodonga
        • Contact:
          • Alan Luckie
      • Liverpool, New South Wales, Australia, 2170
        • Not yet recruiting
        • South West Retina
        • Contact:
          • Gerald Liew
      • Parramatta, New South Wales, Australia, 02150
        • Not yet recruiting
        • Marsden Eye Specialists
        • Contact:
          • Yew Liang Terence Tan
      • Strathfield, New South Wales, Australia, 2135
        • Not yet recruiting
        • Strathfield Retina Clinic
        • Contact:
          • James Wong
      • Sydney, New South Wales, Australia, 2000
        • Not yet recruiting
        • Sydney Eye Hospital
        • Contact:
          • Samantha Fraser-Bell
      • Sydney, New South Wales, Australia, 2000
        • Not yet recruiting
        • Sydney Retina Clinic & Day Surgery
        • Contact:
          • Andrew Chang
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Not yet recruiting
        • Adelaide Eye and Retina Centre
        • Contact:
          • Jagjit Gilhotra
    • Tasmania
      • Hobart, Tasmania, Australia, 7008
        • Not yet recruiting
        • Hobart Eye Surgeons
        • Contact:
          • Nitin Verma
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Not yet recruiting
        • Centre for Eye Research Australia
        • Contact:
          • Sanjeewa Wickremasinghe
  • Japan
      • Fukuoka, Japan, 812-0011
        • Not yet recruiting
        • Hayashi Eye Hospital - Ophthalmology
        • Contact:
          • Ken Hayashi
      • Fukushima, Japan, 960-1295
        • Not yet recruiting
        • Fukushima Medical University Hospital - Ophthalmology
        • Contact:
          • Tetsuju Sekiryu
      • Kyoto, Japan, 607-8062
        • Not yet recruiting
        • Rakuwakai Otowa Hospital
        • Contact:
          • Noriko Miyamoto
      • Saitama, Japan, 330-8553
        • Not yet recruiting
        • Saitama Red Cross Hospital
        • Contact:
          • Kiyoshi Ishii
    • Aiti
      • Nagakute, Aiti, Japan, 480-1195
        • Not yet recruiting
        • Aichi Medical University Hospital - Ophthalmology
        • Contact:
          • Yuichiro Ishida
    • Aiti-ken
      • Nagoya-shi, Aiti-ken, Japan, 462-0825
        • Not yet recruiting
        • MIYAKE Eye Hospital
        • Contact:
          • Kondo Nagako
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Not yet recruiting
        • Toho University Medical Center Sakura Hospital
        • Contact:
          • Fumihiko Yagi
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Not yet recruiting
        • Kurume University Hospital
        • Contact:
          • Shigeo Yoshida
    • Fukushima
      • Koriyama, Fukushima, Japan, 963-8563
        • Not yet recruiting
        • Minamitohoku Eye Clinic
        • Contact:
          • Namie Kobayashi
    • Hyôgo
      • Kobe, Hyôgo, Japan, 650-0017
        • Not yet recruiting
        • Kobe University Hospital - Ophthalmology
        • Contact:
          • Sentaro Kusuhara
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0845
        • Not yet recruiting
        • Kozawa Eye Hospital and Diabetes Center
        • Contact:
          • Takashi Hiroe
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Not yet recruiting
        • Kagawa University Hospital
        • Contact:
          • Kiyoshi Suzuma
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Not yet recruiting
        • Shinshu University Hospital - Ophthalmology
        • Contact:
          • Takao Hirano
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Not yet recruiting
        • Nara Medical University Hospital - Ophthalmology
        • Contact:
          • Tetsuo Ueda
    • Osaka
      • Hirakata, Osaka, Japan, 660-0892
        • Not yet recruiting
        • Kansai Medical University Medical Center
        • Contact:
          • Yoshimi Nagai
      • Osakasayama-shi, Osaka, Japan, 577-8502
        • Not yet recruiting
        • Kindai University Hospital
        • Contact:
          • Shunji Kusaka
    • Shizuoka
      • Susono, Shizuoka, Japan, 410-1102
        • Not yet recruiting
        • Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology
        • Contact:
          • Akira Hagiwara
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Not yet recruiting
        • Jichi Medical University Hospital
        • Contact:
          • Hidenori Takahasi
    • Tokyo
      • Chiyoda, Tokyo, Japan
        • Not yet recruiting
        • Nihon University Hospital
        • Contact:
          • Koji Tanaka
      • Hachiōji, Tokyo, Japan, 193-0998
        • Not yet recruiting
        • Tokyo Medical University Hachioji Medical Center
        • Contact:
          • Masahiko Shimura
      • Meguro-ku, Tokyo, Japan, 152-8902
        • Not yet recruiting
        • Tokyo Medical Center
        • Contact:
          • Kunihiko Akiyama
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Not yet recruiting
        • Keio University Hospital - Ophthalmology
        • Contact:
          • Hajime Shinoda
    • Ôsaka
      • Osaka, Ôsaka, Japan, 545-0051
        • Not yet recruiting
        • Osaka Metropolitan University Hospital
        • Contact:
          • Shigeru Honda
  • Korea, Republic of
      • Seoul, Korea, Republic of, 6591
        • Not yet recruiting
        • The Catholic Univ of KOR, SSMH
        • Contact:
          • Young-Hoon Park
    • Busan Gwang'yeogsi
      • Busan, Busan Gwang'yeogsi, Korea, Republic of, 49241
        • Not yet recruiting
        • Pusan National University Hospital
        • Contact:
          • Iksoo Byon
    • Daegu Gwang'yeogsi
      • Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 42601
        • Not yet recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
          • Yu Cheol Kim
      • Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 42415
        • Not yet recruiting
        • Yeungnam University Hospital
        • Contact:
          • Min Sagong
    • Gyeonggido
      • Seongam, Gyeonggido, Korea, Republic of, 13620
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Se Joon Woo
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13496
        • Not yet recruiting
        • CHA Bundang Medical Center, CHA University
        • Contact:
          • Youngje Sung
    • Incheon Gwang'yeogsi
      • Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
        • Not yet recruiting
        • Gachon University Gil Medical Center
        • Contact:
          • Dong-Heun Nam
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
          • Kyu Hyung Park
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
          • Young Hee Yoon
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Not yet recruiting
        • Samsung Medical Center
        • Contact:
          • Se Woong Kang
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
        • Not yet recruiting
        • Korea University Anam Hospital
        • Contact:
          • Jaeryung Oh
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Not yet recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Christopher Lee
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07301
        • Not yet recruiting
        • Kim Eye Hospital
        • Contact:
          • Jae Hui Kim
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 2447
        • Not yet recruiting
        • Kyung Hee University Hospital
        • Contact:
          • Seung Young Yu
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Not yet recruiting
        • Barnet Dulaney Perkins Eye Center - Phoenix
        • Contact:
          • Jordan Graff
      • Tucson, Arizona, United States, 85710
        • Not yet recruiting
        • Retina Associates Southwest, P.C.
        • Contact:
          • Cameron Javid
    • California
      • Arcadia, California, United States, 91006
        • Recruiting
        • Win Retina
        • Contact:
          • Peter Win
      • Beverly Hills, California, United States, 90211
        • Not yet recruiting
        • Retina Vitreous Associates Medical Group
        • Contact:
          • Firas Rahhal
      • Encino, California, United States, 91436
        • Recruiting
        • The Retina Partners
        • Contact:
          • Hajir Dadgostar
      • Huntington Beach, California, United States, 92647
        • Not yet recruiting
        • Salehi Retina Institute, Inc
        • Contact:
          • Hani Salehi-Had
      • Pasadena, California, United States, 91107
        • Not yet recruiting
        • California Eye Specialists Medical Group Inc
        • Contact:
          • Payam Amini
      • Redlands, California, United States, 92374
        • Not yet recruiting
        • Retina Consultants of Southern California
        • Contact:
          • John Carlson
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Not yet recruiting
        • Retina Consultants of Southern CO
        • Contact:
          • Cecinio Ronquillo
    • Florida
      • Clearwater, Florida, United States, 33761
        • Not yet recruiting
        • Blue Ocean Clinical Research West
        • Contact:
          • Dana Deupree
      • Melbourne, Florida, United States, 32901
        • Not yet recruiting
        • Florida Eye Associates
        • Contact:
          • Vrinda Hershberger
      • Pinellas Park, Florida, United States, 33782
        • Recruiting
        • Eye Associates of Pinellas
        • Contact:
          • Jason Handza
      • Plantation, Florida, United States, 33324
        • Not yet recruiting
        • Ft. Lauderdale Eye Institute
        • Contact:
          • Stuart Burgess
      • Saint Petersburg, Florida, United States, 33711
        • Not yet recruiting
        • Retina Vitreous Associates of Florida - Saint Petersburg
        • Contact:
          • David Eichenbaum
      • Tallahassee, Florida, United States, 32308
        • Not yet recruiting
        • Southern Vitreoretinal Associates
        • Contact:
          • Robert Steinmetz
      • Winter Haven, Florida, United States, 33880
        • Recruiting
        • Center for Retina and Macular Disease - Ophthalmology
        • Contact:
          • Adam Berger
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Mid Atlantic Retina Specialists - Hagerstown
        • Contact:
          • Adam Gerstenblith
    • Nevada
      • Reno, Nevada, United States, 89502
        • Not yet recruiting
        • Sierra Eye Associates
        • Contact:
          • Arshad Khanani
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Not yet recruiting
        • Retina Center of New Jersey
        • Contact:
          • Patrick Higgins
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Not yet recruiting
        • Vision Research Center Eye Associates of New Mexico
        • Contact:
          • John Pitcher
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Retina Vitreous Surgeons of Central NY, PC
        • Contact:
          • Jamin Brown
      • Oceanside, New York, United States, 11572
        • Not yet recruiting
        • Ophthalmic Consultants of Long Island
        • Contact:
          • Ketan Laud
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Not yet recruiting
        • Retina Vitreous Center in Edmond Oklahoma
        • Contact:
          • Sandeep Shah
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • EyeHealth Northwest
        • Contact:
          • Christopher Aderman
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Not yet recruiting
        • Wills Eye Health System
        • Contact:
          • Yoshihiro Yonekawa
      • Kingston, Pennsylvania, United States, 18704
        • Not yet recruiting
        • Eye Care Specialists
        • Contact:
          • Erik Kruger
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Recruiting
        • Retina Consultants of Charleston - (RCA Network Site)
        • Contact:
          • John Kerrison
      • Ladson, South Carolina, United States, 29456
        • Recruiting
        • Charleston Neuroscience Institute (RCA Network Site)
        • Contact:
          • Daniel Alfaro
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Not yet recruiting
        • Charles Retina Institute
        • Contact:
          • Stephen Huddleston
    • Texas
      • Abilene, Texas, United States, 79606
        • Not yet recruiting
        • Retina Research Institute of Texas
        • Contact:
          • Sunil Patel
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Retina Associates - Ophthalmology/Retina (RCA Network site)
        • Contact:
          • Robert Wong
      • Austin, Texas, United States, 78750
        • Not yet recruiting
        • Austin Clinical Research, LLC
        • Contact:
          • Brian Berger
      • Bellaire, Texas, United States, 77401
        • Not yet recruiting
        • Retina Consultants of Texas
        • Contact:
          • David Brown
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • Texas Retina Associates
        • Contact:
          • Patrick Williams
      • San Antonio, Texas, United States, 78240
        • Not yet recruiting
        • Retinal Consultants of Texas- San Antonio (RCA Network site)
        • Contact:
          • Richard Lane
      • The Woodlands, Texas, United States, 77384
        • Not yet recruiting
        • Retina Consultants of Texas (RCA Network Site)
        • Contact:
          • Charles Wykoff
      • Willow Park, Texas, United States, 76087
        • Not yet recruiting
        • Strategic Clinical Research Group, LLC
        • Contact:
          • Seong Lee
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Not yet recruiting
        • University of Vermont Fletcher Allen Health Care
        • Contact:
          • Brian Kim
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Retina Group of Washington
        • Contact:
          • Jordana Goren Fein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary written informed consent to participate in the study
  • BCVA ETDRS letter score of 73 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
    • Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids
    • Previous intraocular device implantation except PC-IOL
    • Previous laser (any type) to the macular area
    • Previous panretinal photocoagulation treatment
    • Previous treatment with any IVT anti-VEGF drugs
    • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
Time Frame: For 36 weeks until the end of the trial
For 36 weeks until the end of the trial

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of aflibercept IVT
Time Frame: For 36 weeks until the end of the trial
For 36 weeks until the end of the trial
Change from baseline in SHRM as measured by SD-OCT
Time Frame: 36 Weeks
36 Weeks
Change from baseline in retinal morphology as measured by SD-OCT
Time Frame: 36 Weeks
36 Weeks
Change from baseline in leakage as measured by FA
Time Frame: 36 Weeks
36 Weeks

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: For 36 weeks until the end of the trial
For 36 weeks until the end of the trial
Serum KHK4951 concentration
Time Frame: 36 Weeks
36 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin, Inc.

Investigators

  • Study Director: Sotaro Takigawa, Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4951-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowakirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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