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A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Sponsor: 4D Molecular Therapeutics
Summary
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)
Official title: A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Efficacy, Safety, and Durability of a Single Intravitreal Injection of 4D-150 Versus Aflibercept in Adults With Diabetic Macular Edema (4SIGHT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
514
Start Date
2026-09-18
Completion Date
2030-01
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
4D-150 IVT (3x10^10 vg)
If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1
EYELEA ® (aflibercept) Injection 2 mg (0.05mL)
EYLEA ® (aflibercept) will be administered at applicable visits
Locations (82)
Research Network Arizona
Scottsdale, Arizona, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Retinal Consultants Medical Group Inc.
Sacramento, California, United States
Retina Consultants San Diego
San Diego, California, United States
Retina Institute of New England
San Mateo, California, United States
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States
Retina Specialists of Colorado - Aurora
Aurora, Colorado, United States
Retina Consultants of Southern Colorado P.C.
Colorado Springs, Colorado, United States
Southwest Retina Consultants
Durango, Colorado, United States
Coastal Eye- Greenwich
Greenwich, Connecticut, United States
Retina Institute of New England, PC
Waterford, Connecticut, United States
Florida Retina Institute
Orlando, Florida, United States
Retinal Specialty Institute
Pensacola, Florida, United States
Fort Lauderdale Eye Institute (FLEI)-Plantation
Plantation, Florida, United States
Retina Vitreous Associates of Florida
Tampa, Florida, United States
Retina Associates, Ltd.
Elmhurst, Illinois, United States
University Retina and Macula Associates
Oak Forest, Illinois, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Midwest Eye Institute
Carmel, Indiana, United States
The Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Mid Atlantic Retina Specialist
Hagerstown, Maryland, United States
Mississippi Retina Associates
Madison, Mississippi, United States
Deep Blue Retina Clinical Research, PLLC
Southaven, Mississippi, United States
The Retina Institute
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
NJ Retina
Edison, New Jersey, United States
NYU Langone Health
New York, New York, United States
Retina Vitreous Surgeons of CNY, PC
New York, New York, United States
Vitreoretinal Consultants of New York (VRCNY)
Westbury, New York, United States
Asheville Eye Associates - Retina Division
Asheville, North Carolina, United States
North Carolina Retina Associates- Wake Forest
Wake Forest, North Carolina, United States
Retina Vitreous Center
Edmund, Oklahoma, United States
EyeHealth Northwest
Portland, Oregon, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
West Texas Retina Consultants
Abilene, Texas, United States
Austin Clinical Research
Austin, Texas, United States
Texas Retina Associate
Dallas, Texas, United States
Texas Retina Center
Houston, Texas, United States
Retina Consultants of Texas - Katy
Katy, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Tyler Retina Consultants
Tyler, Texas, United States
The Retina Group of Washington
Fairfax, Virginia, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States
Beijing Tongren Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, China
The Second Xiangya Hospital of Central South University
Changsha, China
The Second Affiliated Hospital of Harbin Medical University
Haerbin, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Eye Hospital of Shandong First Medical University
Jinan, China
Zhengzhou Second Peoples Hospital
Jinan, China
Lanzhou University Second Hospital
Lanzhou, China
Nanchang University Affiliated Eye Hospital
Nanchang, China
Fudan University - Eye & ENT Hospital
Shanghai, China
Shanghai First People's Hospital
Shanghai, China
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital
Taiyuan, China
Taizhou Hospital of Zhejiang Province
Taizhou, China
Tianjin Medical University Eye Hospital
Tianjin, China
Weifang Eye Hospital
Weifang, China
Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan
Wuhan, China
Wuhan University Renmin Hospital (Hubei General Hospital)
Wuhan, China
Henan Eye Hospital, Henan Provincial People's Hospital
Zhengzhou, China
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, Japan
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
Amagasaki-shi, Japan
Hayashi Eye Hospital
Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, Japan
Kagoshima University Hospital
Kagoshima, Japan
Kagawa University Hospital
Kita-Gun, Japan
Kobe City Eye Hospital
Kobe, Japan
Kyoto University Hospital
Kyoto, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Nagoya University Hospital
Nagoya, Japan
Toho University Sakura Medical Center
Sakura-shi, Japan
Juntendo University Hospital
Tokyo, Japan
National Hospital Organization Tokyo Medical Center
Tokyo, Japan