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ACTIVE NOT RECRUITING

NCT06116916

PHASE2

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

Sponsor: Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-01-09

Completion Date

2026-09-30

Last Updated

2025-10-30

Healthy Volunteers

Conditions

Diabetic Macular Edema (DME)

Interventions

DRUG

KHK4951

KHK4951 eye drop for 36 weeks until end of the trial

DRUG

Aflibercept Injection

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

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

Locations (87)

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