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

NCT06116916 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 4951-003
• Study Type: interventional
• Target: 150
• Locations: 4 countries
• Sites: 87

Brief Summary

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

Conditions

Diabetic Macular Edema (DME)

Outcome Measures

Primary Outcomes (1)

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

  For 36 weeks until the end of the trial

Secondary Outcomes (4)

• The number of aflibercept IVT

  For 36 weeks until the end of the trial

• Change from baseline in SHRM as measured by SD-OCT

  36 Weeks

• Change from baseline in retinal morphology as measured by SD-OCT

  36 Weeks

• Change from baseline in leakage as measured by FA

  36 Weeks

Other Outcomes (2)

• Number of participants with adverse events

  For 36 weeks until the end of the trial

• Serum KHK4951 concentration

  36 Weeks

Study Arms (3)

Arm A

EXPERIMENTAL

KHK4951 High dose

Drug: KHK4951; Drug: Aflibercept Injection

Arm B

EXPERIMENTAL

KHK4951 Middle dose

Drug: KHK4951; Drug: Aflibercept Injection

Arm C

EXPERIMENTAL

KHK4951 Low dose

Drug: KHK4951; Drug: Aflibercept Injection

Interventions

KHK4951 DRUG

KHK4951 eye drop for 36 weeks until end of the trial

Arm A; Arm B; Arm C

Aflibercept Injection DRUG

Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• μm ≥ CST ≥ 325 μm in the study eye at screening
• HbA1c ≤ 11% at screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (87)

Barnet Dulaney Perkins Eye Center - Phoenix

Mesa, Arizona, 85206, United States

Location

Retina Associates Southwest, P.C.

Tucson, Arizona, 85710, United States

Location

Win Retina

Arcadia, California, 91006, United States

Location

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

Salehi Retina Institute, Inc

Huntington Beach, California, 92647, United States

Location

California Eye Specialists Medical Group Inc

Pasadena, California, 91107, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

Retina Consultants of Southern CO

Colorado Springs, Colorado, 80909, United States

Location

Blue Ocean Clinical Research West

Clearwater, Florida, 33761, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Eye Associates of Pinellas

Pinellas Park, Florida, 33782, United States

Location

Ft. Lauderdale Eye Institute

Plantation, Florida, 33324, United States

Location

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida, 33711, United States

Location

Southern Vitreoretinal Associates

Tallahassee, Florida, 32308, United States

Location

Center for Retina and Macular Disease - Ophthalmology

Winter Haven, Florida, 33880, United States

Location

Mid Atlantic Retina Specialists - Hagerstown

Hagerstown, Maryland, 21740, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

Location

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Retina Vitreous Surgeons of Central NY, PC

Liverpool, New York, 13088, United States

Location

Ophthalmic Consultants of Long Island

Oceanside, New York, 11572, United States

Location

Retina Vitreous Center in Edmond Oklahoma

Edmond, Oklahoma, 73013, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Wills Eye Health System

Bethlehem, Pennsylvania, 18017, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Retina Consultants of Charleston - (RCA Network Site)

Charleston, South Carolina, 29414, United States

Location

Charleston Neuroscience Institute (RCA Network Site)

Ladson, South Carolina, 29456, United States

Location

Black Hills Regional Eye Institute - Ophthalmology

Rapid City, South Dakota, 57701, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Retina Associates - Ophthalmology/Retina (RCA Network site)

Austin, Texas, 78705, United States

Location

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Texas Retina Associates

Fort Worth, Texas, 76104, United States

Location

Retinal Consultants of Texas- San Antonio (RCA Network site)

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas (RCA Network Site)

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

University of Vermont Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

Eye Clinic Albury Wodonga

Albury, New South Wales, 02640, Australia

Location

South West Retina

Liverpool, New South Wales, 2170, Australia

Location

Marsden Eye Specialists

Parramatta, New South Wales, 02150, Australia

Location

Strathfield Retina Clinic

Strathfield, New South Wales, 2135, Australia

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Sydney Retina Clinic & Day Surgery

Sydney, New South Wales, 2000, Australia

Location

Adelaide Eye and Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Hobart Eye Surgeons

Hobart, Tasmania, 7008, Australia

Location

Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Aichi Medical University Hospital - Ophthalmology

Nagakute, Aichi-ken, 480-1195, Japan

Location

MIYAKE Eye Hospital

Nagoya, Aichi-ken, 462-0825, Japan

Location

Toho University Medical Center Sakura Hospital

Sakura, Chiba, 285-8741, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Minamitohoku Eye Clinic

Kōriyama, Fukushima, 963-8563, Japan

Location

Caress Sapporo Tokeidai Memorial Hospital

Sapporo, Hokkaidô, 060-0031, Japan

Location

Kobe University Hospital - Ophthalmology

Kobe, Hyôgo, 650-0017, Japan

Location

Kozawa Eye Hospital and Diabetes Center

Mito, Ibaraki, 310-0845, Japan

Location

Kagawa University Hospital

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Shinshu University Hospital - Ophthalmology

Matsumoto, Nagano, 390-8621, Japan

Location

Nara Medical University Hospital - Ophthalmology

Kashihara, Nara, 634-8522, Japan

Location

Kansai Medical University Medical Center

Hirakata, Osaka, 660-0892, Japan

Location

Kindai University Hospital

Sayama, Osaka, 577-8502, Japan

Location

Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology

Susono, Shizuoka, 410-1102, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

Location

Nihon University Hospital

Chiyoda City, Tokyo, Japan

Location

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, 193-0998, Japan

Location

Tokyo Medical Center

Meguro City, Tokyo, 152-8902, Japan

Location

Keio University Hospital - Ophthalmology

Shinjuku, Tokyo, 160-8582, Japan

Location

Hayashi Eye Hospital - Ophthalmology

Fukuoka, 812-0011, Japan

Location

Fukushima Medical University Hospital - Ophthalmology

Fukushima, 960-1295, Japan

Location

Rakuwakai Otowa Hospital

Kyoto, 607-8062, Japan

Location

Saitama Red Cross Hospital

Saitama, 330-8553, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Ôsaka, 545-0051, Japan

Location

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, 42601, South Korea

Location

Pusan National University Hospital

Busan, Gudeok-ro, 49241, South Korea

Location

Seoul National University Bundang Hospital

Seongam, Gyeonggido, 13620, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggido, 13496, South Korea

Location

Yeungnam University Hospital

Daegu, Nam-gu, 42415, South Korea

Location

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

Korea University Anam Hospital

Seoul, Seoul Teugbyeolsi, 02841, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Kim Eye hospital

Seoul, Seoul Teugbyeolsi, 07301, South Korea

Location

Kyung Hee University Hospital

Seoul, Seoul Teugbyeolsi, 2447, South Korea

Location

The Catholic Univ of KOR, SSMH

Seoul, 6591, South Korea

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Sotaro Takigawa

  Kyowa Kirin Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: January 9, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

KR (14); AU (9); JP (24); US (40)