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
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Kyowa Kirin, Inc. |
United States, Australia, Japan, Korea, Republic of,
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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