Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
4D Molecular Therapeutics
Study ID
NCT07064759
Phase
PHASE3
Status
Recruiting
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Conditions

  • Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility Criteria

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

Interventions

  • 4D-150 IVT (3E10 vg/eye) — 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
  • EYLEA® (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 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Key Dates

Start date
Jul 22, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Feb 28, 2029

Study Design

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

Arms

  • Experimental: 4D-150 IVT (3E10 vg/eye)
  • Active Comparator: Aflibercept (AFLB) 2 mg IVT

Primary Outcome Measure

Mean change from baseline in Best Corrected Visual Accuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52 [ Time Frame: 52 Weeks ]

Central Contacts

Locations (54)

FacilityCityStateZIPSite coordinators
Research Network ArizonaScottsdaleArizona85255
Mark Barakat, MD (PRINCIPAL_INVESTIGATOR)
Barnet Dulaney Perkins Eye CenterSun CityArizona85351
Suhail Alam, MD (PRINCIPAL_INVESTIGATOR)
Retina AssociatesTucsonArizona85704
Cameron Javid, MD (PRINCIPAL_INVESTIGATOR)
Retinal Diagnostic CenterCampbellCalifornia95008
Amr Dessouki, MD (PRINCIPAL_INVESTIGATOR)
Retina Consultants of Orange CountyFullertonCalifornia92835
Ashkan Pirouz, MD (PRINCIPAL_INVESTIGATOR)
Northern California Retina Vitreous AssociatesMountain ViewCalifornia94040
Mark Wieland, MD (PRINCIPAL_INVESTIGATOR)
Retinal Consultants Medical GroupSacramentoCalifornia95841
Margaret Chang, MD (PRINCIPAL_INVESTIGATOR)
Retinal Consultants Medical Group Inc.SacramentoCalifornia95825
Joel Pearlman, MD, PhD (PRINCIPAL_INVESTIGATOR)
West Coast Retina Medical GroupSan FranciscoCalifornia94109
Michael Jumper, MD (PRINCIPAL_INVESTIGATOR)
Bay Area Retina AssociatesWalnut CreekCalifornia94598
Subhransu Ray, MD, PhD (PRINCIPAL_INVESTIGATOR)
Retina Consultants of Southern Colorado P.C.Colorado SpringsColorado80909
Standford Taylor, MD (PRINCIPAL_INVESTIGATOR)
Southwest Retina ConsultantsDurangoColorado81303
Sara Haug, MD, PHD (PRINCIPAL_INVESTIGATOR)
ClearVista Clinical ResearchHudsonFlorida34667
Dana Deupree, MD, FASRS (PRINCIPAL_INVESTIGATOR)
Florida Retina InstituteOrlandoFlorida32806
Matthew Cunningham, MD, PhD (PRINCIPAL_INVESTIGATOR)
Retina Specialty InstitutePensacolaFlorida32503
Sunil Gupta, MD (PRINCIPAL_INVESTIGATOR)
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711
David Eichenbaum, MD, FASRS (PRINCIPAL_INVESTIGATOR)
East Florida Eye InstituteStuartFlorida34994
Ronald Frenkel, MD (PRINCIPAL_INVESTIGATOR)
Retina Vitreous Associates of FloridaTampaFlorida33617
Ashley Crane, MD (PRINCIPAL_INVESTIGATOR)
Thomas Eye GroupSandy SpringsGeorgia30328
Paul Kaufman, MD (PRINCIPAL_INVESTIGATOR)
Retina Associates, Ltd.ElmhurstIllinois60126
Aaron Weinberg, MD (PRINCIPAL_INVESTIGATOR)
University Retina and Macula Associates, PCOak ForestIllinois60452
Veeral Sheth, MD, MBA, FACS, FASRS (PRINCIPAL_INVESTIGATOR)
Illinois Retina AssociatesOak ParkIllinois60304
Mathew MacCumber, MD, PhD (PRINCIPAL_INVESTIGATOR)
Springfield ClinicSpringfieldIllinois62703
Ramanath Bhandari, MD (PRINCIPAL_INVESTIGATOR)
Retina Partners Midwest, PCCarmelIndiana46032
Raj Maturi, MD, FASRS (PRINCIPAL_INVESTIGATOR)
The Retina Care CenterBaltimoreMaryland21209
Matthew Speicher, MD (PRINCIPAL_INVESTIGATOR)
Cumberland Valley Retina ConsultantsHagerstownMaryland21740
Allen Hu, MD (PRINCIPAL_INVESTIGATOR)
Mid Atlantic Retina SpecialistHagerstownMaryland21740
Adam Gerstenblith, MD (PRINCIPAL_INVESTIGATOR)
New England Retina ConsultantsSpringfieldMassachusetts01107
David Lally, MD (PRINCIPAL_INVESTIGATOR)
Foundation for Vision ResearchGrand RapidsMichigan49546
Thomas Aaberg, MD (PRINCIPAL_INVESTIGATOR)
Sierra Eye AssociatesRenoNevada89502
Arshad Khanani, MD, MA, FASRS (PRINCIPAL_INVESTIGATOR)
Envision Ocular, LLCBloomfieldNew Jersey07003
Patrick Higgins, MD (PRINCIPAL_INVESTIGATOR)
Retina Vitreous Surgeons of CNY PCLiverpoolNew York13088
Jamin Brown, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital - Columbia University Medical CenterNew YorkNew York10032
Tongalp Tezel, MD (PRINCIPAL_INVESTIGATOR)
Vitreoretinal Consultants of NYWestburyNew York11590
James Lin, MD (PRINCIPAL_INVESTIGATOR)
North Carolina Retina AssociatesCaryNorth Carolina27511
Rebecca Manning, MD (PRINCIPAL_INVESTIGATOR)
North Carolina Retina AssociatesWake ForestNorth Carolina27587
John Thordsen, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Eye InstituteCincinnatiOhio45242
Robert Sisk, MD, FACS, FASRS (PRINCIPAL_INVESTIGATOR)
Verum Research, LLCEugeneOregon947401
Albert Edwards, MD, PhD, MBA (PRINCIPAL_INVESTIGATOR)
EyeHealth NorthwestPortlandOregon97233
Brian Chan-Kai, MD (PRINCIPAL_INVESTIGATOR)
Erie Retina ResearchEriePennsylvania16505
David Almeida, MD, MBA, PhD, DABO, FRCSC, FAS (PRINCIPAL_INVESTIGATOR)
Charleston Neuroscience Institute, LLCBlufftonSouth Carolina29910
Mona Camacci, MD, MS (PRINCIPAL_INVESTIGATOR)
Carolina EyecareMt. PleasantSouth Carolina29464
Jonathan Brugger, MD (PRINCIPAL_INVESTIGATOR)
Palmetto Retina CenterWest ColumbiaSouth Carolina29169
Stephen Hypes, DO (PRINCIPAL_INVESTIGATOR)
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701
Prema Abraham, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Retina, PCNashvilleTennessee37203
Carl Awh, MD, FASRS (PRINCIPAL_INVESTIGATOR)
Southwest Retina Specialist - Panhandle Eye group, LLPAmarilloTexas79106
Jason Edward Ysasaga, MD (PRINCIPAL_INVESTIGATOR)
Austin Clinical ResearchAustinTexas78750
Fuad Makkouk, MD (PRINCIPAL_INVESTIGATOR)
Texas Retina AssociateDallasTexas75231
Ashkan Abbey, MD, FASRS, FAAO (PRINCIPAL_INVESTIGATOR)
Tyler Retina ConsultantsTylerTexas75703
Samuel Minaker, MD (PRINCIPAL_INVESTIGATOR)
Strategic Clinical ResearchWillow ParkTexas76087
Seong Young Lee, MD (PRINCIPAL_INVESTIGATOR)
Rocky Mountain Retina ConsultantsSalt Lake CityUtah84107
Mitchell Goff, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Eye CenterLynchburgVirginia24502
Golnaz Javey, MD (PRINCIPAL_INVESTIGATOR)
Pacific Northwest RetinaSilverdaleWashington98383
Todd Schneiderman, MD, FASRS (PRINCIPAL_INVESTIGATOR)
Eye Clinic of WisconsinWausauWisconsin54403
Deepak Sambhara, MD, FASRS (PRINCIPAL_INVESTIGATOR)

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Research Network Arizona· Scottsdale, AZBarnet Dulaney Perkins Eye Center· Sun City, AZRetina Associates· Tucson, AZRetinal Diagnostic Center· Campbell, CARetina Consultants of Orange County· Fullerton, CANorthern California Retina Vitreous Associates· Mountain View, CA

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