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Eye drops could replace needles for Diabetes-Related vision loss

NCT ID NCT06116916

Disease control Sponsor: Kyowa Kirin Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether KHK4951 eye drops can improve vision in people with diabetic macular edema (DME), a leading cause of blindness. About 150 participants will receive either the eye drops or standard injections. The goal is to see if the drops can reduce swelling and improve eyesight with fewer injections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KHK4951 eye drops
What this could lead to
If it works, this could offer a less invasive eye drop option for diabetic macular edema, potentially reducing the need for frequent eye injections.
What could go wrong
This is an early Phase 2 trial with only 150 participants, so results may not confirm effectiveness. The eye drops may not work as well as current injections, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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 * 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

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema (DME)

Contacts and locations

Locations

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia, 5000, Australia

  • Aichi Medical University Hospital - Ophthalmology

    Nagakute, Aichi-ken, 480-1195, Japan

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Austin Clinical Research, LLC

    Austin, Texas, 78750, United States

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

    Austin, Texas, 78705, United States

  • Barnet Dulaney Perkins Eye Center - Phoenix

    Mesa, Arizona, 85206, United States

  • Black Hills Regional Eye Institute - Ophthalmology

    Rapid City, South Dakota, 57701, United States

  • Blue Ocean Clinical Research West

    Clearwater, Florida, 33761, United States

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggido, 13496, South Korea

  • California Eye Specialists Medical Group Inc

    Pasadena, California, 91107, United States

  • Caress Sapporo Tokeidai Memorial Hospital

    Sapporo, Hokkaidô, 060-0031, Japan

  • Center for Retina and Macular Disease - Ophthalmology

    Winter Haven, Florida, 33880, United States

  • Centre for Eye Research Australia

    East Melbourne, Victoria, 3002, Australia

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • Charleston Neuroscience Institute (RCA Network Site)

    Ladson, South Carolina, 29456, United States

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003, United States

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782, United States

  • Eye Care Specialists

    Kingston, Pennsylvania, 18704, United States

  • Eye Clinic Albury Wodonga

    Albury, New South Wales, 02640, Australia

  • EyeHealth Northwest

    Portland, Oregon, 97225, United States

  • Florida Eye Associates

    Melbourne, Florida, 32901, United States

  • Ft. Lauderdale Eye Institute

    Plantation, Florida, 33324, United States

  • Fukushima Medical University Hospital - Ophthalmology

    Fukushima, 960-1295, Japan

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu, 21565, South Korea

  • Hayashi Eye Hospital - Ophthalmology

    Fukuoka, 812-0011, Japan

  • Hobart Eye Surgeons

    Hobart, Tasmania, 7008, Australia

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498, Japan

  • Kagawa University Hospital

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

  • Kansai Medical University Medical Center

    Hirakata, Osaka, 660-0892, Japan

  • Keimyung University Dongsan Hospital

    Daegu, Dalseo-gu, 42601, South Korea

  • Keio University Hospital - Ophthalmology

    Shinjuku, Tokyo, 160-8582, Japan

  • Kim Eye hospital

    Seoul, Seoul Teugbyeolsi, 07301, South Korea

  • Kindai University Hospital

    Sayama, Osaka, 577-8502, Japan

  • Kobe University Hospital - Ophthalmology

    Kobe, Hyôgo, 650-0017, Japan

  • Korea University Anam Hospital

    Seoul, Seoul Teugbyeolsi, 02841, South Korea

  • Kozawa Eye Hospital and Diabetes Center

    Mito, Ibaraki, 310-0845, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Kyung Hee University Hospital

    Seoul, Seoul Teugbyeolsi, 2447, South Korea

  • MIYAKE Eye Hospital

    Nagoya, Aichi-ken, 462-0825, Japan

  • Marsden Eye Specialists

    Parramatta, New South Wales, 02150, Australia

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland, 21740, United States

  • Minamitohoku Eye Clinic

    Kōriyama, Fukushima, 963-8563, Japan

  • Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology

    Susono, Shizuoka, 410-1102, Japan

  • Nara Medical University Hospital - Ophthalmology

    Kashihara, Nara, 634-8522, Japan

  • Nihon University Hospital

    Chiyoda City, Tokyo, Japan

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572, United States

  • Osaka Metropolitan University Hospital

    Osaka, Ôsaka, 545-0051, Japan

  • Pusan National University Hospital

    Busan, Gudeok-ro, 49241, South Korea

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062, Japan

  • Retina Associates Southwest, P.C.

    Tucson, Arizona, 85710, United States

  • Retina Consultants of Charleston - (RCA Network Site)

    Charleston, South Carolina, 29414, United States

  • Retina Consultants of Southern CO

    Colorado Springs, Colorado, 80909, United States

  • Retina Consultants of Southern California

    Redlands, California, 92374, United States

  • Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas (RCA Network Site)

    The Woodlands, Texas, 77384, United States

  • Retina Group of Washington

    Fairfax, Virginia, 22031, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retina Vitreous Associates of Florida - Saint Petersburg

    St. Petersburg, Florida, 33711, United States

  • Retina Vitreous Center in Edmond Oklahoma

    Edmond, Oklahoma, 73013, United States

  • Retina Vitreous Surgeons of Central NY, PC

    Liverpool, New York, 13088, United States

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

    San Antonio, Texas, 78240, United States

  • Saitama Red Cross Hospital

    Saitama, 330-8553, Japan

  • Salehi Retina Institute, Inc

    Huntington Beach, California, 92647, United States

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongam, Gyeonggido, 13620, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Shinshu University Hospital - Ophthalmology

    Matsumoto, Nagano, 390-8621, Japan

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • South West Retina

    Liverpool, New South Wales, 2170, Australia

  • Southern Vitreoretinal Associates

    Tallahassee, Florida, 32308, United States

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087, United States

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135, Australia

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Sydney Retina Clinic & Day Surgery

    Sydney, New South Wales, 2000, Australia

  • Texas Retina Associates

    Fort Worth, Texas, 76104, United States

  • The Catholic Univ of KOR, SSMH

    Seoul, 6591, South Korea

  • The Retina Partners

    Encino, California, 91436, United States

  • Toho University Medical Center Sakura Hospital

    Sakura, Chiba, 285-8741, Japan

  • Tokyo Medical Center

    Meguro City, Tokyo, 152-8902, Japan

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo, 193-0998, Japan

  • University of Vermont Fletcher Allen Health Care

    Burlington, Vermont, 05401, United States

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

  • Wills Eye Health System

    Bethlehem, Pennsylvania, 18017, United States

  • Win Retina

    Arcadia, California, 91006, United States

  • Yeungnam University Hospital

    Daegu, Nam-gu, 42415, South Korea

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