A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
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
Eylea (aflibercept) will be administered at applicable visits
Mean change from baseline in BCVA ETDRS letter score at Week 52
Time frame: 52 Weeks
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104
Time frame: 104 Weeks
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104
Time frame: 104 Weeks
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm
Time frame: 104 Weeks
Mean change from baseline in CST over time through Weeks 52 and 104
Time frame: 104 Weeks
Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104
Time frame: 104 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
RECRUITINGRetinal Research Institute, LLC
Scottsdale, Arizona, United States
RECRUITINGRetina Partners of Northwest Arkansas
Springdale, Arkansas, United States
RECRUITINGCalifornia Retina Consultants
Bakersfield, California, United States
RECRUITINGRetina Vitreous Associates Medical Group
Beverly Hills, California, United States
RECRUITINGThe Retina Partners
Encino, California, United States
RECRUITINGRetina Associates of Southern California
Huntington Beach, California, United States
RECRUITINGLoma Linda University Faculty Medical Clinics
Loma Linda, California, United States
RECRUITINGJules Stein Eye Institute
Los Angeles, California, United States
RECRUITINGNorthern California Retina Vitreous Associates
Mountain View, California, United States
RECRUITING...and 93 more locations