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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06116916
Other study ID # 4951-003
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 9, 2024
Est. completion date December 2025

Study information

Verified date April 2024
Source Kyowa Kirin Co., Ltd.
Contact Kyowa Kirin, Inc.
Phone +1-609-919-1100
Email kkd.clintrial.82@kyowakirin.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Voluntary written informed consent to participate in the study - BCVA ETDRS letter score of 73 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 - Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids - Previous intraocular device implantation except PC-IOL - Previous laser (any type) to the macular area - Previous panretinal photocoagulation treatment - Previous treatment with any IVT anti-VEGF drugs - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Australia Adelaide Eye and Retina Centre Adelaide South Australia
Australia Eye Clinic Albury Wodonga Albury New South Wales
Australia Centre for Eye Research Australia East Melbourne Victoria
Australia Hobart Eye Surgeons Hobart Tasmania
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
Japan Nihon University Hospital Chiyoda Tokyo
Japan Hayashi Eye Hospital - Ophthalmology Fukuoka
Japan Fukushima Medical University Hospital - Ophthalmology Fukushima
Japan Tokyo Medical University Hachioji Medical Center Hachioji Tokyo
Japan Kansai Medical University Medical Center Hirakata Osaka
Japan Nara Medical University Hospital - Ophthalmology Kashihara Nara
Japan Kagawa University Hospital Kita-gun Kagawa
Japan Kobe University Hospital - Ophthalmology Kobe Hyôgo
Japan Minamitohoku Eye Clinic Koriyama Fukushima
Japan Kurume University Hospital Kurume Fukuoka
Japan Rakuwakai Otowa Hospital Kyoto
Japan Shinshu University Hospital - Ophthalmology Matsumoto Nagano
Japan Tokyo Medical Center Meguro-ku Tokyo
Japan Kozawa Eye Hospital and Diabetes Center Mito Ibaraki
Japan Aichi Medical University Hospital - Ophthalmology Nagakute Aiti
Japan MIYAKE Eye Hospital Nagoya-shi Aiti-ken
Japan Osaka Metropolitan University Hospital Osaka Ôsaka
Japan Kindai University Hospital Osakasayama-shi Osaka
Japan Saitama Red Cross Hospital Saitama
Japan Toho University Medical Center Sakura Hospital Sakura Chiba
Japan Caress Sapporo Tokeidai Memorial Hospital Sapporo Hokkaidô [Hokkaido]
Japan Jichi Medical University Hospital Shimotsuke Tochigi
Japan Keio University Hospital - Ophthalmology Shinjuku-Ku Tokyo
Japan Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology Susono Shizuoka
Korea, Republic of Pusan National University Hospital Busan Busan Gwang'yeogsi
Korea, Republic of Keimyung University Dongsan Hospital Daegu Daegu Gwang'yeogsi
Korea, Republic of Yeungnam University Hospital Daegu Daegu Gwang'yeogsi
Korea, Republic of Gachon University Gil Medical Center Incheon Incheon Gwang'yeogsi
Korea, Republic of Seoul National University Bundang Hospital Seongam Gyeonggido
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam-si Gyeonggido
Korea, Republic of Asan Medical Center Seoul Seoul Teugbyeolsi
Korea, Republic of Kim Eye hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Korea University Anam Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Kyung Hee University Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Samsung Medical Center Seoul Seoul Teugbyeolsi
Korea, Republic of Seoul National University Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seoul Teugbyeolsi
Korea, Republic of The Catholic Univ of KOR, SSMH Seoul
United States Retina Research Institute of Texas Abilene Texas
United States Vision Research Center Eye Associates of New Mexico Albuquerque New Mexico
United States Win Retina Arcadia California
United States Austin Clinical Research, LLC Austin Texas
United States Austin Retina Associates - Ophthalmology/Retina (RCA Network site) Austin Texas
United States Retina Consultants of Texas Bellaire Texas
United States Wills Eye Health System Bethlehem Pennsylvania
United States Retina Vitreous Associates Medical Group Beverly Hills California
United States Retina Center of New Jersey Bloomfield New Jersey
United States University of Vermont Fletcher Allen Health Care Burlington Vermont
United States Retina Consultants of Charleston - (RCA Network Site) Charleston South Carolina
United States Blue Ocean Clinical Research West Clearwater Florida
United States Retina Consultants of Southern CO Colorado Springs Colorado
United States Retina Vitreous Center in Edmond Oklahoma Edmond Oklahoma
United States The Retina Partners Encino California
United States Retina Group of Washington Fairfax Virginia
United States Texas Retina Associates Fort Worth Texas
United States Charles Retina Institute Germantown Tennessee
United States Mid Atlantic Retina Specialists - Hagerstown Hagerstown Maryland
United States Salehi Retina Institute, Inc Huntington Beach California
United States Eye Care Specialists Kingston Pennsylvania
United States Charleston Neuroscience Institute (RCA Network Site) Ladson South Carolina
United States Retina Vitreous Surgeons of Central NY, PC Liverpool New York
United States Florida Eye Associates Melbourne Florida
United States Barnet Dulaney Perkins Eye Center - Phoenix Mesa Arizona
United States Ophthalmic Consultants of Long Island Oceanside New York
United States California Eye Specialists Medical Group Inc Pasadena California
United States Eye Associates of Pinellas Pinellas Park Florida
United States Ft. Lauderdale Eye Institute Plantation Florida
United States EyeHealth Northwest Portland Oregon
United States Retina Consultants of Southern California Redlands California
United States Sierra Eye Associates Reno Nevada
United States Retina Vitreous Associates of Florida - Saint Petersburg Saint Petersburg Florida
United States Retinal Consultants of Texas- San Antonio (RCA Network site) San Antonio Texas
United States Southern Vitreoretinal Associates Tallahassee Florida
United States Retina Consultants of Texas (RCA Network Site) The Woodlands Texas
United States Retina Associates Southwest, P.C. Tucson Arizona
United States Strategic Clinical Research Group, LLC Willow Park Texas
United States Center for Retina and Macular Disease - Ophthalmology Winter Haven Florida

Sponsors (1)

Lead Sponsor Collaborator
Kyowa Kirin, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Japan,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of participants with adverse events For 36 weeks until the end of the trial
Other Serum KHK4951 concentration 36 Weeks
Primary Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline For 36 weeks until the end of the trial
Secondary The number of aflibercept IVT For 36 weeks until the end of the trial
Secondary Change from baseline in SHRM as measured by SD-OCT 36 Weeks
Secondary Change from baseline in retinal morphology as measured by SD-OCT 36 Weeks
Secondary Change from baseline in leakage as measured by FA 36 Weeks
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