4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
4D Molecular Therapeutics
Study ID
NCT05197270
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Neovascular (Wet) Age-Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • 4D-150 IVT — BIOLOGICAL
    4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
  • Aflibercept IVT — BIOLOGICAL
    Commercially available Active Comparator Other Name: Eylea

Study Details

Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment. Substudies will evaluate the safety and tolerability of 4D-150 contralateral eye dosing and characterize vector shedding.

Key Dates

Start date
Dec 9, 2021
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Jan 31, 2031

Study Design

Enrollment
215 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 4D-150 Dose Escalation up to 4 dose levels
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Dose Expansion Dose 1
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Dose Expansion Dose 2
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Active Comparator: 4D-150 Dose Expansion Control
    Aflibercept at a fixed regimen will be administered.
  • Experimental: 4D-150 Steroid Optimization
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Population Extension Dose 1
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Population Extension Dose 2
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Population Extension Dose 3
    4D-150 will be administered at the assigned dose
  • Experimental: 4D-150 Contralateral Eye Dose
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Vector Shedding Dose
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.

Primary Outcome Measure

Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant changes in safety parameters [ Time Frame: 52 weeks ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Barnet Delaney Perkins Eye CenterPhoenixArizona85016
Dallin Stuart
[email protected]
Suhail Alam, M.D. (PRINCIPAL_INVESTIGATOR)
California Retina ConsultantsOxnardCalifornia93036
Annette Beltran-Almaza
[email protected]
Dante Pieramici, M.D. (PRINCIPAL_INVESTIGATOR)
Retinal Consultants Medical GroupSacramentoCalifornia95841
Rashin Sedighi
[email protected]
Joel Pearlman, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Colorado Retina AssociatesLakewoodColorado80288
Lindsay Harrigan
[email protected]
Murtaza Adam, MD (PRINCIPAL_INVESTIGATOR)
Rand Eye InstituteDeerfield BeachFlorida33064-
Retina Vitreous Consultants, LLP DBA Retina Group of FloridaFort LauderdaleFlorida33308-
Vitreo Retinal AssociatesGainesvilleFlorida32607
Christine Kay, M.D. (PRINCIPAL_INVESTIGATOR)
Florida Eye AssociatesMelbourneFlorida32901
Melissa Dougherty
[email protected]
Vrinda Hershberger, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Retinal Specialty InstitutePensacolaFlorida32503
Vera Watkins, R.N.
[email protected]
Sunil Gupta, M.D. (PRINCIPAL_INVESTIGATOR)
Retina Vitreous Associates of FloridaTampaFlorida33607
Kimberly Velez
[email protected]
David Eichenbaum, M.D. (PRINCIPAL_INVESTIGATOR)
University Retina and Macula AssociatesOak ForestIllinois60452
Cindy Vallejo
[email protected]
Veeral Sheth, M.D. (PRINCIPAL_INVESTIGATOR)
Retina Partners MidwestCarmelIndiana46290
Lorraine White
[email protected]
Raj Maturi, MD (PRINCIPAL_INVESTIGATOR)
Cumberland Valley Retina ConsultantsHagerstownMaryland21740
Allen Hu, M.D. (PRINCIPAL_INVESTIGATOR)
Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser CenterBostonMassachusetts02114
Jeffrey Heier, MD (PRINCIPAL_INVESTIGATOR)
Sierra Eye AssociatesRenoNevada89502
Arshad Khanani, M.D., M.A. (PRINCIPAL_INVESTIGATOR)
Western Carolina Retinal AssociatesAshevilleNorth Carolina28803-
Verum Research, LLCEugeneOregon97401
Lillian Carroll
[email protected]
Albert Edwards, MD (PRINCIPAL_INVESTIGATOR)
Mid Atlantic RetinaBethlehemPennsylvania18017
Leah Kritzwiser
[email protected]
Ajay Kuriyan, MD (PRINCIPAL_INVESTIGATOR)
Palmetto Retina Center, LLCWest ColumbiaSouth Carolina29169
John Wells, MD (PRINCIPAL_INVESTIGATOR)
Tennessee RetinaNashvilleTennessee37203
Carl Awh, MD (PRINCIPAL_INVESTIGATOR)
Austin Clinical ResearchAustinTexas78750
Ivana Gunderson
[email protected]
Fuad Makkouk, M.D. (PRINCIPAL_INVESTIGATOR)
Valley Retina Institute, PAMcAllenTexas78503
Yesenia Salinas
[email protected]
Victor Gonzalez, M.D. (PRINCIPAL_INVESTIGATOR)
Retina Consultants of TexasThe WoodlandsTexas77384-
Pacific Northwest Retina LLCBellevueWashington98004-

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Barnet Delaney Perkins Eye Center· Phoenix, AZCalifornia Retina Consultants· Oxnard, CARetinal Consultants Medical Group· Sacramento, CAColorado Retina Associates· Lakewood, CORand Eye Institute· Deerfield Beach, FLRetina Vitreous Consultants, LLP DBA Retina Group of Florida· Fort Lauderdale, FL

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