Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema (DME)
- Interventions
- Registration Number
- NCT06116916
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
-
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 nAMD 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B KHK4951 KHK4951 Middle dose Arm B Aflibercept Injection KHK4951 Middle dose Arm C KHK4951 KHK4951 Low dose Arm C Aflibercept Injection KHK4951 Low dose Arm A Aflibercept Injection KHK4951 High dose Arm A KHK4951 KHK4951 High dose
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The number of aflibercept IVT For 36 weeks until the end of the trial Change from baseline in leakage as measured by FA 36 Weeks Change from baseline in SHRM as measured by SD-OCT 36 Weeks Change from baseline in retinal morphology as measured by SD-OCT 36 Weeks
Trial Locations
- Locations (174)
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
🇺🇸Saint 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
MIYAKE Eye Hospital
🇯🇵Nagoya-shi, Aiti-ken, Japan
Aichi Medical University Hospital - Ophthalmology
🇯🇵Nagakute, Aiti, Japan
Toho University Medical Center Sakura Hospital
🇯🇵Sakura, Chiba, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Minamitohoku Eye Clinic
🇯🇵Koriyama, 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, 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
🇯🇵Osakasayama-shi, Osaka, Japan
Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology
🇯🇵Susono, Shizuoka, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Nihon University Hospital
🇯🇵Chiyoda, Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Hachiōji, Tokyo, Japan
Tokyo Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Keio University Hospital - Ophthalmology
🇯🇵Shinjuku-Ku, 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, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Gudeok-ro, 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
Yeungnam University Hospital
🇰🇷Daegu, Nam-gu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Namdong-gu, Korea, Republic of
Korea University Anam Hospital
🇰🇷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
Asan Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kim Eye hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic Univ of KOR, SSMH
🇰🇷Seoul, Korea, Republic of
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
🇺🇸Saint 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
MIYAKE Eye Hospital
🇯🇵Nagoya, Aichi, Japan
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, Japan
Toho University Medical Center Sakura Hospital
🇯🇵Sakura, Chiba, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Minamitohoku Eye Clinic
🇯🇵Koriyama, 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, 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
🇯🇵Osakasayama, Osaka, Japan
Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology
🇯🇵Susono, Shizuoka, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Nihon University Hospital
🇯🇵Chiyoda, Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Hachiōji, Tokyo, Japan
Tokyo Medical Center
🇯🇵Meguro, 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, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Gudeok-ro, 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
Yeungnam University Hospital
🇰🇷Daegu, Nam-gu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Namdong-gu, Korea, Republic of
Korea University Anam Hospital
🇰🇷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
Asan Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kim Eye hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic Univ of KOR, SSMH
🇰🇷Seoul, Korea, Republic of