Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

June 30, 2012

Study Completion Date

August 31, 2013

Conditions
Age-Related Macular Degeneration
Interventions
DRUG

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."

DRUG

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."

Trial Locations (1)

33136

Bascom Palmer Eye Institute, Miami

Sponsors
All Listed Sponsors
collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

lead

Philip J. Rosenfeld, MD, PhD

OTHER