60
Participants
Start Date
July 31, 2009
Primary Completion Date
June 30, 2012
Study Completion Date
August 31, 2013
Eculizumab
"Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
Saline
"Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
Bascom Palmer Eye Institute, Miami
Collaborators (1)
Alexion Pharmaceuticals, Inc.
INDUSTRY
Philip J. Rosenfeld, MD, PhD
OTHER