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

Diabetic Macular Edema (DME) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116916
• Other study ID #: 4951-003
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Edema
• Macular Edema

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	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