4D-150 in Patients With Diabetic Macular Edema

Part of paid clinical trials in Hagerstown, Maryland.

Sponsor
4D Molecular Therapeutics
Study ID
NCT05930561
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 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

Study Details

Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME).

Key Dates

Start date
Aug 9, 2023
Status verified
Sep 2025
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4D-150 Part 1 Dose Confirmation Dose Level 1
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Part 1 Dose Confirmation Dose Level 2
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Part 2 Dose Expansion Dose Level 1
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Experimental: 4D-150 Part 2 Dose Expansion Dose Level 2
    4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
  • Active Comparator: 4D-150 Part 2 Dose Expansion Control
    Aflibercept at a fixed regimen will be administered.

Primary Outcome Measure

Incidence and severity of TEAEs and SAEs, including clinically significant changes in safety parameters (Part 1) [ Time Frame: 60 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Verum Research, LLCEugeneOregon97401-
Erie Retina ResearchEriePennsylvania16507-
Austin Clinical ResearchAustinTexas78750-
Piedmont Eye CenterLynchburgVirginia24502-

Find similar trials in Hagerstown, MD

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Cumberland Valley Retina Consultants· Hagerstown, MDVerum Research, LLC· Eugene, ORErie Retina Research· Erie, PAAustin Clinical Research· Austin, TXPiedmont Eye Center· Lynchburg, VA

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