Diabetic Macular Edema (DME)Phase 2NCT06116916
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
A Phase 2 study testing KHK4951 and Aflibercept Injection in people with Diabetic Macular Edema (DME), run by Kyowa Kirin Co., Ltd. at 87 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- KHK4951 and Aflibercept Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 87 sitesin 4 countries
- Study dates
- 9 Jan 2024to 30 Nov 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
87 sites in 4 countries.
87 sites in 4 countries
United States40 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
Win Retina
Arcadia, California, 91006
Austin Retina Associates - Ophthalmology/Retina (RCA Network site)
Austin, Texas, 78705
Austin Clinical Research, LLC
Austin, Texas, 78750
Retina Consultants of Texas
Bellaire, Texas, 77401
Wills Eye Health System
Bethlehem, Pennsylvania, 18017
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
University of Vermont Fletcher Allen Health Care
Burlington, Vermont, 05401
Retina Consultants of Charleston - (RCA Network Site)
Charleston, South Carolina, 29414
Blue Ocean Clinical Research West
Clearwater, Florida, 33761
Retina Consultants of Southern CO
Colorado Springs, Colorado, 80909
Retina Vitreous Center in Edmond Oklahoma
Edmond, Oklahoma, 73013
The Retina Partners
Encino, California, 91436
Retina Group of Washington
Fairfax, Virginia, 22031
Texas Retina Associates
Fort Worth, Texas, 76104
Charles Retina Institute
Germantown, Tennessee, 38138
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, 21740
Salehi Retina Institute, Inc
Huntington Beach, California, 92647
Eye Care Specialists
Kingston, Pennsylvania, 18704
Charleston Neuroscience Institute (RCA Network Site)
Ladson, South Carolina, 29456
Retina Vitreous Surgeons of Central NY, PC
Liverpool, New York, 13088
Florida Eye Associates
Melbourne, Florida, 32901
Barnet Dulaney Perkins Eye Center - Phoenix
Mesa, Arizona, 85206
Ophthalmic Consultants of Long Island
Oceanside, New York, 11572
California Eye Specialists Medical Group Inc
Pasadena, California, 91107
Eye Associates of Pinellas
Pinellas Park, Florida, 33782
Ft. Lauderdale Eye Institute
Plantation, Florida, 33324
EyeHealth Northwest
Portland, Oregon, 97225
Black Hills Regional Eye Institute - Ophthalmology
Rapid City, South Dakota, 57701
Retina Consultants of Southern California
Redlands, California, 92374
Sierra Eye Associates
Reno, Nevada, 89502
Retinal Consultants of Texas- San Antonio (RCA Network site)
San Antonio, Texas, 78240
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, 33711
Southern Vitreoretinal Associates
Tallahassee, Florida, 32308
Retina Consultants of Texas (RCA Network Site)
The Woodlands, Texas, 77384
Retina Associates Southwest, P.C.
Tucson, Arizona, 85710
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087
Center for Retina and Macular Disease - Ophthalmology
Winter Haven, Florida, 33880
Japan24 sites
Nihon University Hospital
Chiyoda City, Tokyo
Hayashi Eye Hospital - Ophthalmology
Fukuoka, 812-0011
Fukushima Medical University Hospital - Ophthalmology
Fukushima, 960-1295
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 193-0998
Kansai Medical University Medical Center
Hirakata, Osaka, 660-0892
Nara Medical University Hospital - Ophthalmology
Kashihara, Nara, 634-8522
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
Kobe University Hospital - Ophthalmology
Kobe, Hyôgo, 650-0017
Minamitohoku Eye Clinic
Kōriyama, Fukushima, 963-8563
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Rakuwakai Otowa Hospital
Kyoto, 607-8062
Shinshu University Hospital - Ophthalmology
Matsumoto, Nagano, 390-8621
Tokyo Medical Center
Meguro City, Tokyo, 152-8902
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, 310-0845
Aichi Medical University Hospital - Ophthalmology
Nagakute, Aichi-ken, 480-1195
MIYAKE Eye Hospital
Nagoya, Aichi-ken, 462-0825
Osaka Metropolitan University Hospital
Osaka, Ôsaka, 545-0051
Saitama Red Cross Hospital
Saitama, 330-8553
Toho University Medical Center Sakura Hospital
Sakura, Chiba, 285-8741
Caress Sapporo Tokeidai Memorial Hospital
Sapporo, Hokkaidô, 060-0031
Kindai University Hospital
Sayama, Osaka, 577-8502
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
Keio University Hospital - Ophthalmology
Shinjuku, Tokyo, 160-8582
Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology
Susono, Shizuoka, 410-1102
South Korea14 sites
Pusan National University Hospital
Busan, Gudeok-ro, 49241
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, 42601
Yeungnam University Hospital
Daegu, Nam-gu, 42415
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
Seoul National University Bundang Hospital
Seongam, Gyeonggido, 13620
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggido, 13496
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi, 02841
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
Asan Medical Center
Seoul, Seoul Teugbyeolsi, 05505
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, 06351
Kim Eye hospital
Seoul, Seoul Teugbyeolsi, 07301
Kyung Hee University Hospital
Seoul, Seoul Teugbyeolsi, 2447
The Catholic Univ of KOR, SSMH
Seoul, 6591
Australia9 sites
Adelaide Eye and Retina Centre
Adelaide, South Australia, 5000
Eye Clinic Albury Wodonga
Albury, New South Wales, 02640
Centre for Eye Research Australia
East Melbourne, Victoria, 3002
Hobart Eye Surgeons
Hobart, Tasmania, 7008
South West Retina
Liverpool, New South Wales, 2170
Marsden Eye Specialists
Parramatta, New South Wales, 02150
Strathfield Retina Clinic
Strathfield, New South Wales, 2135
Sydney Eye Hospital
Sydney, New South Wales, 2000
Sydney Retina Clinic & Day Surgery
Sydney, New South Wales, 2000
About this study
Official title: 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.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- KHK4951, Aflibercept Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4951Drug
KHK4951 eye drop for 36 weeks until end of the trial
Aflibercept InjectionDrug
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | KHK4951 High dose Receives: Drug: KHK4951; Drug: Aflibercept Injection |
| Arm B | Experimental | KHK4951 Middle dose Receives: Drug: KHK4951; Drug: Aflibercept Injection |
| Arm C | Experimental | KHK4951 Low dose Receives: Drug: KHK4951; Drug: Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
Measured: For 36 weeks until the end of the trial
Secondary outcomes (4)
The number of aflibercept IVT
Measured: For 36 weeks until the end of the trial
Change from baseline in SHRM as measured by SD-OCT
Measured: 36 Weeks
Change from baseline in retinal morphology as measured by SD-OCT
Measured: 36 Weeks
Change from baseline in leakage as measured by FA
Measured: 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start9 Jan 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sotaro Takigawa, Study director, Kyowa Kirin Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116916
- Sponsor's protocol ID
- 4951-003
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.