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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Are there results?
Not yet: the study is under way

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
Show all 20Show fewer
  • 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

Other trials in United States

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

Other trials in Japan

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

Other trials in South Korea

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

Other trials in Australia

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.

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 groups in NCT06116916
Study groupRoleWhat they receive
Arm AExperimentalKHK4951 High dose
Receives: Drug: KHK4951; Drug: Aflibercept Injection
Arm BExperimentalKHK4951 Middle dose
Receives: Drug: KHK4951; Drug: Aflibercept Injection
Arm CExperimentalKHK4951 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.

  1. 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)

  1. The number of aflibercept IVT

    Measured: For 36 weeks until the end of the trial

  2. Change from baseline in SHRM as measured by SD-OCT

    Measured: 36 Weeks

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

    Measured: 36 Weeks

  4. 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.

  1. First posted3 Nov 2023
  2. Study start9 Jan 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Japan, South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06116916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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