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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
4D Molecular Therapeutics
Study ID
NCT07867080
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 4D-150 IVT (3x10^10 vg) — BIOLOGICAL
    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) — BIOLOGICAL
    EYLEA ® (aflibercept) will be administered at applicable visits

Study Details

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)

Key Dates

First listed
Oct 9, 2026
Start date
Sep 18, 2026
Status verified
Oct 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
514 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4D-150 IVT (3x10^10 vg/eye)
  • Active Comparator: Active Comparator (AFLB) 2mg IVT

Primary Outcome Measure

Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52 [ Time Frame: 52 weeks ]

Central Contacts

Locations (49)

FacilityCityStateZIPSite coordinators
Research Network ArizonaScottsdaleArizona85255-
The Retina PartnersEncinoCalifornia91436-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Retinal Consultants Medical Group Inc.SacramentoCalifornia95825-
Retina Consultants San DiegoSan DiegoCalifornia92064-
Retina Institute of New EnglandSan MateoCalifornia94401-
Bay Area Retina Associates - Walnut CreekWalnut CreekCalifornia94598-
Retina Specialists of Colorado - AuroraAuroraColorado80012-
Retina Consultants of Southern Colorado P.C.Colorado SpringsColorado80909-
Southwest Retina ConsultantsDurangoColorado81303-
Coastal Eye- GreenwichGreenwichConnecticut06830-
Retina Institute of New England, PCWaterfordConnecticut06385-
Florida Retina InstituteOrlandoFlorida32806-
Retinal Specialty InstitutePensacolaFlorida32503-
Fort Lauderdale Eye Institute (FLEI)-PlantationPlantationFlorida33324-
Retina Vitreous Associates of FloridaTampaFlorida33607-
Retina Associates, Ltd.ElmhurstIllinois60126-
University Retina and Macula AssociatesOak ForestIllinois60452-
Illinois Retina AssociatesOak ParkIllinois60304-
Springfield ClinicSpringfieldIllinois62703-
Midwest Eye InstituteCarmelIndiana46032-
The Retina Group of WashingtonChevy ChaseMaryland20815-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Mid Atlantic Retina SpecialistHagerstownMaryland21740-
Mississippi Retina AssociatesMadisonMississippi39110-
Deep Blue Retina Clinical Research, PLLCSouthavenMississippi38671-
The Retina InstituteSt LouisMissouri63128-
Sierra Eye AssociatesRenoNevada89502-
Envision Ocular, LLCBloomfieldNew Jersey07003-
NJ RetinaEdisonNew Jersey08820-
NYU Langone HealthNew YorkNew York10017-
Retina Vitreous Surgeons of CNY, PCNew YorkNew York13088-
Vitreoretinal Consultants of New York (VRCNY)WestburyNew York11590-
Asheville Eye Associates - Retina DivisionAshevilleNorth Carolina28803-
North Carolina Retina Associates- Wake ForestWake ForestNorth Carolina27587-
Retina Vitreous CenterEdmundOklahoma73013-
EyeHealth NorthwestPortlandOregon97233-
Mid Atlantic RetinaBethlehemPennsylvania18017-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-
West Texas Retina ConsultantsAbileneTexas79606-
Austin Clinical ResearchAustinTexas78750-
Texas Retina AssociateDallasTexas75231-
Texas Retina CenterHoustonTexas77030-
Retina Consultants of Texas - KatyKatyTexas77494-
Retina Consultants of TexasThe WoodlandsTexas77384-
Tyler Retina ConsultantsTylerTexas75703-
The Retina Group of WashingtonFairfaxVirginia22031-
Piedmont Eye CenterLynchburgVirginia24502-
Eye Clinic of WisconsinWausauWisconsin55403-

Find similar trials in Scottsdale, AZ

By research site
Research Network Arizona· Scottsdale, AZThe Retina Partners· Encino, CARetina Consultants of Orange County· Fullerton, CARetinal Consultants Medical Group Inc.· Sacramento, CARetina Consultants San Diego· San Diego, CARetina Institute of New England· San Mateo, CA

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