Tests 4D-150 eye injection against aflibercept in diabetic macular edema
Tests a single eye injection, 4D-150, against aflibercept in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Key facts
- Where
- Abilene, Asheville, Aurora, Austin, Bethlehem, Bloomfield, Bluffton, Carmel, Cary, Charleston, Chevy Chase, Colorado Springs, Dallas, Durango, Edison, Edmund, Elmhurst, Encino, Fairfax, Fort Lauderdale, Fullerton, Greenwich, Hagerstown, Houston, Huntington Beach, Katy, Lemont, Lynchburg, Madison, Middleburg Heights, Nashville, New York, Oak Park, Orlando, Pensacola, Philadelphia, Plantation, Portland, Rapid City, Reno, Sacramento, San Diego, San Mateo, Scottsdale, Southaven, Springfield, St Louis, Tampa, The Woodlands, Tyler, Wake Forest, Walnut Creek, Waterford, Wausau, and Westbury, United StatesSee the 59 sites
- Phase
- Phase 3
Where in United States
- West Texas Retina ConsultantsAbilene, United StatesNot yet recruiting
- Asheville Eye Associates - Retina DivisionAsheville, United StatesTaking people
- Retina Specialists of Colorado - AuroraAurora, United StatesTaking people
- Austin Clinical ResearchAustin, United StatesTaking people
- Austin Research Center for RetinaAustin, United StatesNot yet recruiting
- Austin Retina AssociatesAustin, United StatesNot yet recruiting
- Mid Atlantic RetinaBethlehem, United StatesNo longer taking part
- Envision Ocular, LLCBloomfield, United StatesTaking people
- Retina Consultants of South CarolinaBluffton, United StatesNot yet recruiting
- Midwest Eye InstituteCarmel, United StatesNot yet recruiting
- North Carolina Retina Associates - Cary OfficeCary, United StatesNot yet recruiting
- Charleston Neuroscience Institute, LLCCharleston, United StatesNot yet recruiting
- The Retina Group of WashingtonChevy Chase, United StatesNot yet recruiting
- Retina Consultants of Southern Colorado P.C.Colorado Springs, United StatesNot yet recruiting
- Texas Retina AssociateDallas, United StatesTaking people
- Southwest Retina ConsultantsDurango, United StatesTaking people
- NJ RetinaEdison, United StatesNot yet recruiting
- Retina Vitreous CenterEdmund, United StatesTaking people
- Retina Associates, Ltd.Elmhurst, United StatesTaking people
- The Retina PartnersEncino, United StatesTaking people
- The Retina Group of WashingtonFairfax, United StatesTaking people
- Retina Group of FloridaFort Lauderdale, United StatesNot yet recruiting
- Retina Consultants of Orange CountyFullerton, United StatesNot yet recruiting
- Coastal Eye- GreenwichGreenwich, United StatesTaking people
- Cumberland Valley Retina ConsultantsHagerstown, United StatesNot yet recruiting
- Mid Atlantic Retina SpecialistHagerstown, United StatesNot yet recruiting
- Texas Retina CenterHouston, United StatesTaking people
- Retina Associates of Southern CaliforniaHuntington Beach, United StatesNot yet recruiting
- Retina Consultants of Texas - KatyKaty, United StatesNot yet recruiting
- University Retina and Macula Associates PC - LemontLemont, United StatesTaking people
- Piedmont Eye CenterLynchburg, United StatesTaking people
- Mississippi Retina AssociatesMadison, United StatesNot yet recruiting
- Retina Associates of ClevelandMiddleburg Heights, United StatesNot yet recruiting
- Tennessee RetinaNashville, United StatesNot yet recruiting
- NYU Langone HealthNew York, United StatesNot yet recruiting
- Retina Vitreous Surgeons of CNY, PCNew York, United StatesTaking people
- Illinois Retina AssociatesOak Park, United StatesNot yet recruiting
- Florida Retina InstituteOrlando, United StatesNot yet recruiting
- Retinal Specialty InstitutePensacola, United StatesTaking people
- Mid Atlantic Retina - PhiladelphiaPhiladelphia, United StatesNot yet recruiting
- Fort Lauderdale Eye Institute (FLEI)-PlantationPlantation, United StatesNot yet recruiting
- EyeHealth NorthwestPortland, United StatesNot yet recruiting
- Black Hills Regional Eye InstituteRapid City, United StatesTaking people
- Sierra Eye AssociatesReno, United StatesTaking people
- Retinal Consultants Medical Group, Inc.Sacramento, United StatesNot yet recruiting
- Retina Consultants San DiegoSan Diego, United StatesNot yet recruiting
- Retina Institute of New EnglandSan Mateo, United StatesNot yet recruiting
- Research Network ArizonaScottsdale, United StatesTaking people
- Deep Blue Retina Clinical Research PLLCSouthaven, United StatesTaking people
- Springfield ClinicSpringfield, United StatesNot yet recruiting
- The Retina InstituteSt Louis, United StatesNot yet recruiting
- Retina Vitreous Associates of FloridaTampa, United StatesTaking people
- Retina Consultants of TexasThe Woodlands, United StatesNot yet recruiting
- Tyler Retina ConsultantsTyler, United StatesTaking people
- North Carolina Retina Associates (Wake Forest)Wake Forest, United StatesNot yet recruiting
- Bay Area Retina Associates - Walnut CreekWalnut Creek, United StatesNot yet recruiting
- Retina Institute of New England, PCWaterford, United StatesNot yet recruiting
- Eye Clinic of WisconsinWausau, United StatesTaking people
- Vitreoretinal Consultants of New York (VRCNY)Westbury, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- 4D Molecular Therapeutics
- Trial code
- NCT07867080
- Record updated
- 10 November 2026
- Original description
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)Read full original descriptionShow less
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)
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)
Exclusion: Any prior concomitant treatment for DME; History of prior significant ocular surgery or treatment; Any prior investigational drug, agent, device, or gene therapy; 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:; History or presence of moderate Proliferative Diabetic Retinopathy or worse; History or presence of low Intraocular Pressure.
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.