Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
NCT ID: NCT06116916
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-01-09
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
KHK4951 High dose
KHK4951
KHK4951 eye drop for 36 weeks until end of the trial
Aflibercept Injection
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Arm B
KHK4951 Middle dose
KHK4951
KHK4951 eye drop for 36 weeks until end of the trial
Aflibercept Injection
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Arm C
KHK4951 Low dose
KHK4951
KHK4951 eye drop for 36 weeks until end of the trial
Aflibercept Injection
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Interventions
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KHK4951
KHK4951 eye drop for 36 weeks until end of the trial
Aflibercept Injection
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 DME 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
18 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sotaro Takigawa
Role: STUDY_DIRECTOR
Kyowa Kirin Co., Ltd.
Locations
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Barnet Dulaney Perkins Eye Center - Phoenix
Mesa, Arizona, United States
Retina Associates Southwest, P.C.
Tucson, Arizona, United States
Win Retina
Arcadia, California, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
The Retina Partners
Encino, California, United States
Salehi Retina Institute, Inc
Huntington Beach, California, United States
California Eye Specialists Medical Group Inc
Pasadena, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retina Consultants of Southern CO
Colorado Springs, Colorado, United States
Blue Ocean Clinical Research West
Clearwater, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
Ft. Lauderdale Eye Institute
Plantation, Florida, United States
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, United States
Southern Vitreoretinal Associates
Tallahassee, Florida, United States
Center for Retina and Macular Disease - Ophthalmology
Winter Haven, Florida, United States
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Retina Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, United States
Retina Vitreous Center in Edmond Oklahoma
Edmond, Oklahoma, United States
EyeHealth Northwest
Portland, Oregon, United States
Wills Eye Health System
Bethlehem, Pennsylvania, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Retina Consultants of Charleston - (RCA Network Site)
Charleston, South Carolina, United States
Charleston Neuroscience Institute (RCA Network Site)
Ladson, South Carolina, United States
Black Hills Regional Eye Institute - Ophthalmology
Rapid City, South Dakota, United States
Charles Retina Institute
Germantown, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Austin Retina Associates - Ophthalmology/Retina (RCA Network site)
Austin, Texas, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Texas Retina Associates
Fort Worth, Texas, United States
Retinal Consultants of Texas- San Antonio (RCA Network site)
San Antonio, Texas, United States
Retina Consultants of Texas (RCA Network Site)
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
University of Vermont Fletcher Allen Health Care
Burlington, Vermont, United States
Retina Group of Washington
Fairfax, Virginia, United States
Eye Clinic Albury Wodonga
Albury, New South Wales, Australia
South West Retina
Liverpool, New South Wales, Australia
Marsden Eye Specialists
Parramatta, New South Wales, Australia
Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic & Day Surgery
Sydney, New South Wales, Australia
Adelaide Eye and Retina Centre
Adelaide, South Australia, Australia
Hobart Eye Surgeons
Hobart, Tasmania, Australia
Centre for Eye Research Australia
East Melbourne, Victoria, Australia
Aichi Medical University Hospital - Ophthalmology
Nagakute, Aichi-ken, Japan
MIYAKE Eye Hospital
Nagoya, Aichi-ken, Japan
Toho University Medical Center Sakura Hospital
Sakura, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Minamitohoku Eye Clinic
Kōriyama, Fukushima, Japan
Caress Sapporo Tokeidai Memorial Hospital
Sapporo, Hokkaidô, Japan
Kobe University Hospital - Ophthalmology
Kobe, Hyôgo, Japan
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Shinshu University Hospital - Ophthalmology
Matsumoto, Nagano, Japan
Nara Medical University Hospital - Ophthalmology
Kashihara, Nara, Japan
Kansai Medical University Medical Center
Hirakata, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology
Susono, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Nihon University Hospital
Chiyoda City, Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, Japan
Tokyo Medical Center
Meguro City, Tokyo, Japan
Keio University Hospital - Ophthalmology
Shinjuku, Tokyo, Japan
Hayashi Eye Hospital - Ophthalmology
Fukuoka, , Japan
Fukushima Medical University Hospital - Ophthalmology
Fukushima, , Japan
Rakuwakai Otowa Hospital
Kyoto, , Japan
Saitama Red Cross Hospital
Saitama, , Japan
Osaka Metropolitan University Hospital
Osaka, Ôsaka, Japan
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, South Korea
Pusan National University Hospital
Busan, Gudeok-ro, South Korea
Seoul National University Bundang Hospital
Seongam, Gyeonggido, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggido, South Korea
Yeungnam University Hospital
Daegu, Nam-gu, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Kim Eye hospital
Seoul, Seoul Teugbyeolsi, South Korea
Kyung Hee University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic Univ of KOR, SSMH
Seoul, , South Korea
Countries
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Other Identifiers
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4951-003
Identifier Type: -
Identifier Source: org_study_id
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