Phase 3 Study of Intravitreal 4D-150 in Adults With Diabetic Macular Edema (DME) (4D-150-C005)
4SIGHT
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)
2 other identifiers
interventional
514
3 countries
82
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2026
Typical duration for phase_3
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2026
CompletedFirst Submitted
Initial submission to the registry
October 5, 2026
CompletedFirst Posted
Study publicly available on registry
October 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
October 9, 2026
October 1, 2026
2.3 years
October 5, 2026
October 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52
52 weeks
Secondary Outcomes (2)
Mean annualized number of aflibercept injections after Week 4 through Week 52
Week 4 through Week 52
Proportion of participants with a ≥ 2-step improvement from baseline in Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52
52 weeks
Study Arms (2)
4D-150 IVT (3x10^10 vg/eye)
EXPERIMENTALActive Comparator (AFLB) 2mg IVT
ACTIVE COMPARATORInterventions
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
EYLEA ® (aflibercept) will be administered at applicable visits
Eligibility Criteria
You may qualify if:
- Signed informed consent before any protocol-specified assessment is performed
- Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment
- ≥18 years of age at time of signing informed consent
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- WOCBP must agree to use highly effective contraception from the time of informed consent, through duration of trial participation
- Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye
- Study eye amenable to IVT injection identified
- Presence of intraretinal fluid and/or subretinal fluid secondary to DME
- Decreased visual acuity attributable primarily to DME, as determined by the Investigator
- Demonstrated clinical response to aflibercept and functional stability in the study eye
You may not qualify if:
- Ocular Condition
- Macular conditions other than DME
- History or presence of moderate Proliferative Diabetic Retinopathy or worse
- History of retinal detachment in the study eye
- History or presence of active inflammation or infection in either eye
- History or presence of low Intraocular Pressure
- Uncontrolled glaucoma or intraocular hypertension
- Ocular Treatments/Interventions:
- Any prior concomitant treatment for DME
- History of prior significant ocular surgery or treatment
- Any prior investigational drug, agent, device, or gene therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Research Network Arizona
Scottsdale, Arizona, 85255, United States
The Retina Partners
Encino, California, 91436, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Retinal Consultants Medical Group Inc.
Sacramento, California, 95825, United States
Retina Consultants San Diego
San Diego, California, 92064, United States
Retina Institute of New England
San Mateo, California, 94401, United States
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, 94598, United States
Retina Specialists of Colorado - Aurora
Aurora, Colorado, 80012, United States
Retina Consultants of Southern Colorado P.C.
Colorado Springs, Colorado, 80909, United States
Southwest Retina Consultants
Durango, Colorado, 81303, United States
Coastal Eye- Greenwich
Greenwich, Connecticut, 06830, United States
Retina Institute of New England, PC
Waterford, Connecticut, 06385, United States
Florida Retina Institute
Orlando, Florida, 32806, United States
Retinal Specialty Institute
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute (FLEI)-Plantation
Plantation, Florida, 33324, United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33607, United States
Retina Associates, Ltd.
Elmhurst, Illinois, 60126, United States
University Retina and Macula Associates
Oak Forest, Illinois, 60452, United States
Illinois Retina Associates
Oak Park, Illinois, 60304, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Midwest Eye Institute
Carmel, Indiana, 46032, United States
The Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialist
Hagerstown, Maryland, 21740, United States
Mississippi Retina Associates
Madison, Mississippi, 39110, United States
Deep Blue Retina Clinical Research, PLLC
Southaven, Mississippi, 38671, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003, United States
NJ Retina
Edison, New Jersey, 08820, United States
NYU Langone Health
New York, New York, 10017, United States
Retina Vitreous Surgeons of CNY, PC
New York, New York, 13088, United States
Vitreoretinal Consultants of New York (VRCNY)
Westbury, New York, 11590, United States
Asheville Eye Associates - Retina Division
Asheville, North Carolina, 28803, United States
North Carolina Retina Associates- Wake Forest
Wake Forest, North Carolina, 27587, United States
Retina Vitreous Center
Edmund, Oklahoma, 73013, United States
EyeHealth Northwest
Portland, Oregon, 97233, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, 18017, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
West Texas Retina Consultants
Abilene, Texas, 79606, United States
Austin Clinical Research
Austin, Texas, 78750, United States
Texas Retina Associate
Dallas, Texas, 75231, United States
Texas Retina Center
Houston, Texas, 77030, United States
Retina Consultants of Texas - Katy
Katy, Texas, 77494, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
Tyler Retina Consultants
Tyler, Texas, 75703, United States
The Retina Group of Washington
Fairfax, Virginia, 22031, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, 55403, United States
Beijing Tongren Hospital
Beijing, 100730, China
The Second Hospital of Jilin University
Changchun, 130041, China
The Second Xiangya Hospital of Central South University
Changsha, 410300, China
The Second Affiliated Hospital of Harbin Medical University
Haerbin, 150001, China
Zhejiang Provincial People's Hospital
Hangzhou, 310015, China
Eye Hospital of Shandong First Medical University
Jinan, 250021, China
Zhengzhou Second Peoples Hospital
Jinan, 450006, China
Lanzhou University Second Hospital
Lanzhou, 730030, China
Nanchang University Affiliated Eye Hospital
Nanchang, 330006, China
Fudan University - Eye & ENT Hospital
Shanghai, 200031, China
Shanghai First People's Hospital
Shanghai, 200080, China
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital
Taiyuan, 030032, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317000, China
Tianjin Medical University Eye Hospital
Tianjin, 300384, China
Weifang Eye Hospital
Weifang, 261021, China
Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan
Wuhan, 430014, China
Wuhan University Renmin Hospital (Hubei General Hospital)
Wuhan, 430060, China
Henan Eye Hospital, Henan Provincial People's Hospital
Zhengzhou, 450003, China
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, 310-0845, Japan
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
Amagasaki-shi, 660-8550, Japan
Hayashi Eye Hospital
Fukuoka, 812-0011, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, 193-0998, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Kagawa University Hospital
Kita-Gun, 761-0793, Japan
Kobe City Eye Hospital
Kobe, 650-0047, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Toho University Sakura Medical Center
Sakura-shi, 285-8741, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
National Hospital Organization Tokyo Medical Center
Tokyo, 152-8902, Japan
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2026
First Posted
October 9, 2026
Study Start
September 18, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2030
Last Updated
October 9, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will share
Data obtained through this study may be provided, after deidentification, to qualified researchers with academic interest in DME in compliance with ICMJE policy. Data or samples shared will be coded, with no Protected Health Information included. Additionally, descriptions of the study protocol, Statistical Analysis Plan (SAP), informed consent and clinical study report may be shared publicly. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting after final Clinical Study Report and the data will be made accessible for a duration determined by the Sponsor, and in accordance with ICMJE policy. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and execution of a Data Sharing Agreement (DSA)