Status and phase
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About
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Enrollment
Sex
Ages
Volunteers
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:
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups
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4DMT Patient Advocacy
Data sourced from clinicaltrials.gov
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