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Clinical Trial Summary

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02387957
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Terminated
Phase Phase 2
Start date April 26, 2016
Completion date January 2017

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