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
- Diseases
- Diabetic eye disease
- 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
Sites (87)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tongren Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Not yet recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Haerbin | China | Not yet recruiting |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Zhengzhou Second Peoples Hospital Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Eye Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Not yet recruiting |
| Nanchang University Affiliated Eye Hospital Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Fudan University Eye & ENT Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai First People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Not yet recruiting |
| Tianjin Medical University Eye Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Weifang Eye Hospital Coordinator of this site? Confirm its status | Weifang | China | Not yet recruiting |
| Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Wuhan University - Renmin Hospital (Hubei General Hospital) Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Henan Eye Hospital, Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) Coordinator of this site? Confirm its status | Amagasaki-shi | Japan | Not yet recruiting |
| Hayashi Eye Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Not yet recruiting |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Not yet recruiting |
| Fukushima Medical University Hospital Coordinator of this site? Confirm its status | Fukushima | Japan | Not yet recruiting |
| Tokyo Medical University Hachioji Medical Center Coordinator of this site? Confirm its status | Hachioji-shi | Japan | Not yet recruiting |
| Kagoshima University Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Not yet recruiting |
| Kagawa University Hospital Coordinator of this site? Confirm its status | Kita-gun | Japan | Not yet recruiting |
| Kobe City Eye Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Not yet recruiting |
| Kyoto University Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Not yet recruiting |
| Kyorin University - Kyorin University Hospital - Mitaka Coordinator of this site? Confirm its status | Mitaka-shi | Japan | Not yet recruiting |
| Kozawa Eye Hospital and Diabetes Center Coordinator of this site? Confirm its status | Mito | Japan | Not yet recruiting |
| University of Miyazaki Hospital Coordinator of this site? Confirm its status | Miyazaki | Japan | Not yet recruiting |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Not yet recruiting |
| Toho University Sakura Medical Center Coordinator of this site? Confirm its status | Sakura-shi | Japan | Not yet recruiting |
| National Hospital Organization Tokyo Medical Center Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| West Texas Retina Consultants Coordinator of this site? Confirm its status | Abilene | United States | Not yet recruiting |
| Asheville Eye Associates - Retina Division Coordinator of this site? Confirm its status | Asheville | United States | Not yet recruiting |
| Retina Specialists of Colorado - Aurora Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Austin Clinical Research Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Mid Atlantic Retina Coordinator of this site? Confirm its status | Bethlehem | United States | Withdrawn |
| Envision Ocular, LLC Coordinator of this site? Confirm its status | Bloomfield | United States | Recruiting |
| Midwest Eye Institute Coordinator of this site? Confirm its status | Carmel | United States | Not yet recruiting |
| North Carolina Retina Associates - Cary Office Coordinator of this site? Confirm its status | Cary | United States | Not yet recruiting |
| The Retina Group of Washington Coordinator of this site? Confirm its status | Chevy Chase | United States | Not yet recruiting |
| Retina Consultants of Southern Colorado P.C. Coordinator of this site? Confirm its status | Colorado Springs | United States | Not yet recruiting |
| Texas Retina Associate Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Southwest Retina Consultants Coordinator of this site? Confirm its status | Durango | United States | Not yet recruiting |
| NJ Retina Coordinator of this site? Confirm its status | Edison | United States | Not yet recruiting |
| Retina Vitreous Center Coordinator of this site? Confirm its status | Edmund | United States | Not yet recruiting |
| Retina Associates, Ltd. Coordinator of this site? Confirm its status | Elmhurst | United States | Recruiting |
| The Retina Partners Coordinator of this site? Confirm its status | Encino | United States | Recruiting |
| The Retina Group of Washington Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Retina Consultants of Orange County Coordinator of this site? Confirm its status | Fullerton | United States | Not yet recruiting |
| Coastal Eye- Greenwich Coordinator of this site? Confirm its status | Greenwich | United States | Recruiting |
| Mid Atlantic Retina Specialist Coordinator of this site? Confirm its status | Hagerstown | United States | Not yet recruiting |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Not yet recruiting |
| Texas Retina Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Retina Consultants of Texas - Katy Coordinator of this site? Confirm its status | Katy | United States | Not yet recruiting |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Not yet recruiting |
| Mississippi Retina Associates Coordinator of this site? Confirm its status | Madison | United States | Not yet recruiting |
| Retina Associates of Cleveland Coordinator of this site? Confirm its status | Middleburg Heights | United States | Not yet recruiting |
| Tennessee Retina Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Retina Vitreous Surgeons of CNY, PC Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University Retina and Macula Associates Coordinator of this site? Confirm its status | Oak Forest | United States | Not yet recruiting |
| Illinois Retina Associates Coordinator of this site? Confirm its status | Oak Park | United States | Not yet recruiting |
| Florida Retina Institute Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
| Retinal Specialty Institute Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| Mid Atlantic Retina - Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| Fort Lauderdale Eye Institute (FLEI)-Plantation Coordinator of this site? Confirm its status | Plantation | United States | Not yet recruiting |
| EyeHealth Northwest Coordinator of this site? Confirm its status | Portland | United States | Not yet recruiting |
| Black Hills Regional Eye Institute Coordinator of this site? Confirm its status | Rapid City | United States | Recruiting |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Retinal Consultants Medical Group, Inc. Coordinator of this site? Confirm its status | Sacramento | United States | Not yet recruiting |
| Retina Consultants San Diego Coordinator of this site? Confirm its status | San Diego | United States | Not yet recruiting |
| Retina Institute of New England Coordinator of this site? Confirm its status | San Mateo | United States | Not yet recruiting |
| Research Network Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Deep Blue Retina Clinical Research PLLC Coordinator of this site? Confirm its status | Southaven | United States | Not yet recruiting |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Not yet recruiting |
| The Retina Institute Coordinator of this site? Confirm its status | St Louis | United States | Not yet recruiting |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Not yet recruiting |
| Tyler Retina Consultants Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| North Carolina Retina Associates (Wake Forest) Coordinator of this site? Confirm its status | Wake Forest | United States | Not yet recruiting |
| Bay Area Retina Associates - Walnut Creek Coordinator of this site? Confirm its status | Walnut Creek | United States | Not yet recruiting |
| Retina Institute of New England, PC Coordinator of this site? Confirm its status | Waterford | United States | Not yet recruiting |
| Eye Clinic of Wisconsin Coordinator of this site? Confirm its status | Wausau | United States | Not yet recruiting |
| Vitreoretinal Consultants of New York (VRCNY) Coordinator of this site? Confirm its status | Westbury | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.