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NCT07867080RecruitingPhase 3

A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).

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)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
514 (estimated)
First submitted
5 Oct 2026
Start date
18 Sept 2026
Primary completion date
Jan 2029
Lead sponsor
4D Molecular Therapeutics
NCT number
NCT07867080

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 514
  • From 18 Sept 2026 to the primary completion date, Jan 2029
  • 87 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any prior concomitant treatment for DME
  • History of prior significant ocular surgery or treatment
  • Any prior investigational drug, agent, device, or gene therapy

Other illness

  • Ocular Condition
  • Macular conditions other than DME
  • History of retinal detachment in the study eye
  • History or presence of active inflammation or infection in either eye
  • Uncontrolled glaucoma or intraocular hypertension
    • Ocular Treatments/Interventions:

Other

  • History or presence of moderate Proliferative Diabetic Retinopathy or worse
  • History or presence of low Intraocular Pressure

Criteria the registry did not label

  • 5.2 Inclusion Criteria
  • Individuals eligible to participate in the trial must meet the following inclusion criteria:
  • General Inclusion Criteria
  • 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
  • Agree to use a barrier method (e.g., condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period Ocular Inclusion Criteria
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (87)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Tongren Hospital
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BeijingChinaNot yet recruiting
The Second Hospital of Jilin University
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ChangchunChinaNot yet recruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaNot yet recruiting
The Second Affiliated Hospital of Harbin Medical University
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HaerbinChinaNot yet recruiting
Zhejiang Provincial People's Hospital
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HangzhouChinaNot yet recruiting
Zhengzhou Second Peoples Hospital
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JinanChinaNot yet recruiting
Eye Hospital of Shandong First Medical University
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JinanChinaNot yet recruiting
Lanzhou University Second Hospital
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LanzhouChinaNot yet recruiting
Nanchang University Affiliated Eye Hospital
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NanchangChinaNot yet recruiting
Fudan University Eye & ENT Hospital
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ShanghaiChinaNot yet recruiting
Shanghai First People's Hospital
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ShanghaiChinaNot yet recruiting
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital
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TaiyuanChinaNot yet recruiting
Taizhou Hospital of Zhejiang Province
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TaizhouChinaNot yet recruiting
Tianjin Medical University Eye Hospital
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TianjinChinaNot yet recruiting
Weifang Eye Hospital
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WeifangChinaNot yet recruiting
Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan
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WuhanChinaNot yet recruiting
Wuhan University - Renmin Hospital (Hubei General Hospital)
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WuhanChinaNot yet recruiting
Henan Eye Hospital, Henan Provincial People's Hospital
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ZhengzhouChinaNot yet recruiting
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
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Amagasaki-shiJapanNot yet recruiting
Hayashi Eye Hospital
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FukuokaJapanNot yet recruiting
Kyushu University Hospital
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FukuokaJapanNot yet recruiting
Fukushima Medical University Hospital
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FukushimaJapanNot yet recruiting
Tokyo Medical University Hachioji Medical Center
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Hachioji-shiJapanNot yet recruiting
Kagoshima University Hospital
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KagoshimaJapanNot yet recruiting
Kagawa University Hospital
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Kita-gunJapanNot yet recruiting
Kobe City Eye Hospital
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KobeJapanNot yet recruiting
Kyoto University Hospital
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KyotoJapanNot yet recruiting
Kyorin University - Kyorin University Hospital - Mitaka
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Mitaka-shiJapanNot yet recruiting
Kozawa Eye Hospital and Diabetes Center
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MitoJapanNot yet recruiting
University of Miyazaki Hospital
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MiyazakiJapanNot yet recruiting
Nagoya University Hospital
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NagoyaJapanNot yet recruiting
Toho University Sakura Medical Center
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Sakura-shiJapanNot yet recruiting
National Hospital Organization Tokyo Medical Center
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TokyoJapanNot yet recruiting
Juntendo University Hospital
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TokyoJapanNot yet recruiting
West Texas Retina Consultants
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AbileneUnited StatesNot yet recruiting
Asheville Eye Associates - Retina Division
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AshevilleUnited StatesNot yet recruiting
Retina Specialists of Colorado - Aurora
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AuroraUnited StatesRecruiting
Austin Clinical Research
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AustinUnited StatesRecruiting
Mid Atlantic Retina
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BethlehemUnited StatesWithdrawn
Envision Ocular, LLC
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BloomfieldUnited StatesRecruiting
Midwest Eye Institute
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CarmelUnited StatesNot yet recruiting
North Carolina Retina Associates - Cary Office
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CaryUnited StatesNot yet recruiting
The Retina Group of Washington
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Chevy ChaseUnited StatesNot yet recruiting
Retina Consultants of Southern Colorado P.C.
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Colorado SpringsUnited StatesNot yet recruiting
Texas Retina Associate
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DallasUnited StatesRecruiting
Southwest Retina Consultants
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DurangoUnited StatesNot yet recruiting
NJ Retina
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EdisonUnited StatesNot yet recruiting
Retina Vitreous Center
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EdmundUnited StatesNot yet recruiting
Retina Associates, Ltd.
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ElmhurstUnited StatesRecruiting
The Retina Partners
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EncinoUnited StatesRecruiting
The Retina Group of Washington
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FairfaxUnited StatesRecruiting
Retina Consultants of Orange County
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FullertonUnited StatesNot yet recruiting
Coastal Eye- Greenwich
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GreenwichUnited StatesRecruiting
Mid Atlantic Retina Specialist
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HagerstownUnited StatesNot yet recruiting
Cumberland Valley Retina Consultants
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HagerstownUnited StatesNot yet recruiting
Texas Retina Center
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HoustonUnited StatesRecruiting
Retina Consultants of Texas - Katy
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KatyUnited StatesNot yet recruiting
Piedmont Eye Center
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LynchburgUnited StatesNot yet recruiting
Mississippi Retina Associates
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MadisonUnited StatesNot yet recruiting
Retina Associates of Cleveland
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Middleburg HeightsUnited StatesNot yet recruiting
Tennessee Retina
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NashvilleUnited StatesNot yet recruiting
NYU Langone Health
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New YorkUnited StatesNot yet recruiting
Retina Vitreous Surgeons of CNY, PC
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New YorkUnited StatesRecruiting
University Retina and Macula Associates
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Oak ForestUnited StatesNot yet recruiting
Illinois Retina Associates
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Oak ParkUnited StatesNot yet recruiting
Florida Retina Institute
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OrlandoUnited StatesNot yet recruiting
Retinal Specialty Institute
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PensacolaUnited StatesRecruiting
Mid Atlantic Retina - Philadelphia
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PhiladelphiaUnited StatesNot yet recruiting
Fort Lauderdale Eye Institute (FLEI)-Plantation
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PlantationUnited StatesNot yet recruiting
EyeHealth Northwest
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PortlandUnited StatesNot yet recruiting
Black Hills Regional Eye Institute
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Rapid CityUnited StatesRecruiting
Sierra Eye Associates
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RenoUnited StatesRecruiting
Retinal Consultants Medical Group, Inc.
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SacramentoUnited StatesNot yet recruiting
Retina Consultants San Diego
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San DiegoUnited StatesNot yet recruiting
Retina Institute of New England
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San MateoUnited StatesNot yet recruiting
Research Network Arizona
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ScottsdaleUnited StatesRecruiting
Deep Blue Retina Clinical Research PLLC
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SouthavenUnited StatesNot yet recruiting
Springfield Clinic
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SpringfieldUnited StatesNot yet recruiting
The Retina Institute
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St LouisUnited StatesNot yet recruiting
Retina Vitreous Associates of Florida
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TampaUnited StatesRecruiting
Retina Consultants of Texas
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The WoodlandsUnited StatesNot yet recruiting
Tyler Retina Consultants
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TylerUnited StatesRecruiting
North Carolina Retina Associates (Wake Forest)
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Wake ForestUnited StatesNot yet recruiting
Bay Area Retina Associates - Walnut Creek
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Walnut CreekUnited StatesNot yet recruiting
Retina Institute of New England, PC
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WaterfordUnited StatesNot yet recruiting
Eye Clinic of Wisconsin
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WausauUnited StatesNot yet recruiting
Vitreoretinal Consultants of New York (VRCNY)
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WestburyUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.