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
4D Molecular Therapeutics
Summary
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ≥50 years of age at time of consent * MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator * Active subfoveal MNV or juxtafoveal/ extrafoveal M…
Interventions
- Biological4D-150 IVT (3E10 vg/eye)
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
- BiologicalEYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea (aflibercept) will be administered at applicable visits
Locations (94)
- Research Network ArizonaScottsdale, Arizona
- Barnet Dulaney Perkins Eye CenterSun City, Arizona
- Retina AssociatesTucson, Arizona
- Retinal Diagnostic CenterCampbell, California
- Retina Consultants of Orange CountyFullerton, California
- Northern California Retina Vitreous AssociatesMountain View, California