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
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
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
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:
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
Exclusion Criteria:
Ocular Conditions:
Ocular Treatments/Interventions:
Systemic Conditions and Considerations:
clinicaltrials@4DMT.com(888) 748-8881
Scottsdale, Arizona 85255, United States
Mountain View, California 94040, United States
Colorado Springs, Colorado 80909, United States
New York, New York 10032, United States
Amarillo, Texas 79106, United States
Fukuoka, 811-0213, Japan