4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
a study on Macular Degeneration
Summary
- Eligibility
- for people ages 50 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedstudy 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:
- Major illness or major surgical procedure in the 28 days prior to the Screening Visit
- Uncontrolled blood pressure
- Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
- History of autoimmune condition that may predispose to the development of uveitis
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 - Orange County Retina Medical Group
accepting new patients
Santa Ana California 92705 United States - Retina Associates of Southern California
accepting new patients
Huntington Beach California 92647 United States - Gavin Herbert Eye Institute
not yet accepting patients
Orange California 92868 United States - Retina Consultants of San Diego
accepting new patients
Poway California 92064 United States - Retinal Consultants Medical Group Inc
accepting new patients
Sacramento California 95840 United States - Retinal Consultants Medical Group Inc
accepting new patients
Sacramento California 95825 United States - Bay Area Retina Associates
accepting new patients
Walnut Creek California 94598 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
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