Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

Summary

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Official Title

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Keywords

Macular Neovascularization Secondary to Age-Related Macular Degeneration, Age-related macular degeneration, AMD, Exudative AMD, Neovascular AMD, Exudative age-related macular degeneration, Neovascular age-related macular degeneration, Wet age-related macular degeneration, Wet macular degeneration, Wet AMD, wAMD, Retinal gene therapy, Intravitreal gene therapy, Genetic Medicine, Ocular Gene Therapy, nAMD, Macular Degeneration, aflibercept, Injections, 4D-150 IVT (3E10 vg/eye), EYLEA® (aflibercept) Injection 2 mg (0.05mL), Aflibercept (AFLB) 2 mg IVT

Eligibility

You can join if…

Open to people ages 50 years and up

  • ≥50 years of age at time of consent
  • Treatment naïve MNV secondary to nAMD in the study eye
  • Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT), in the study eye, at the Screening Visit confirmed by the Reading Center
  • Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
  • BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit
  • CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center

You CAN'T join if...

Ocular Conditions:

  • MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter))
  • History of retinal detachment in the study eye
  • History of or presence of active inflammation in either eye
  • Glaucoma or intraocular hypertension requiring more than 2 topical medications for control

Systemic Conditions and Considerations:

Locations

  • Jules Stein Eye Institute accepting new patients
    Los Angeles California 90095 United States
  • Retina Vitreous Associates Medical Group accepting new patients
    Beverly Hills California 90211 United States
  • The Retina Partners accepting new patients
    Encino California 91436 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
4D Molecular Therapeutics
ID
NCT06864988
Phase
Phase 3 Macular Degeneration Research Study
Study Type
Interventional
Participants
Expecting 480 study participants
Last Updated