To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.
60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows: * Avastin® 1.25 mg/eye (20 subjects) * Lucentis® 0.5 mg/eye (20 subjects) * Eylea® 2.0 mg/eye (20 subjects) Subjects will be stratified by lesion size (≤2 DA vs. \>2 DA). Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months. When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Beverly Hills, California, United States
Total Numer of Systemic Adverse Events
Number of Patients with Systemic Adverse Events
Time frame: 2 years
Total Number of Other Adverse Events (>5%)
Number of Patients with Other Adverse Events
Time frame: 2 years
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Unnamed facility
Sacramento, California, United States
Unnamed facility
Santa Ana, California, United States
Unnamed facility
New London, Connecticut, United States
Unnamed facility
Fort Lauderdale, Florida, United States
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
Augusta, Georgia, United States
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Oak Forest, Illinois, United States
Unnamed facility
Boston, Massachusetts, United States
...and 14 more locations