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



Status:Archived
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2009
End Date:July 2011

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Eculizumab for the Treatment of Non-Exudative Age-Related Macular Degeneration: An Exploratory Study to Evaluate the Effects of C5 Inhibition on Drusen and Geographic Atrophy


To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated
by the change in drusen volume and area of geographic atrophy.


This is a randomized, double-arm, double-masked study designed to evaluate the safety and
efficacy of eculizumab for the treatment of patients with dry AMD. There are three stages in
the study: the screening period, the treatment period, and the follow-up period.During the
screening period patients will be evaluated for eligibility. Eligible patients will receive
either eculizumab or placebo for 24 weeks.

A total of 60 patients will be enrolled and divided equally between the drusen cohort and
the GA cohort. A 2:1 randomization will result in 20 patients in each cohort receiving
eculizumab while 10 patients receive placebo.

The treatment period will begin two weeks after administration of the meningococcal vaccine.
During the treatment period, patients will receive eculizumab or placebo over a period of
approximately 26 weeks. Patient will treatment according to the following regimen:

Induction Period: patient will receive eculizumab 600 mg via IV infusion over approximately
30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg eculizumab for the fifth
dose 7 days later (7 ± 2 days).

Maintenance Period: patient will receive eculizumab 900 mg via IV infusion over
approximately 30 minutes every 2 weeks (14 ± 2 days).

After the final scheduled dose of eculizumab or Placebo at week 24, patients will return for
follow-up exam 2 weeks, 3 months, and 6 months after the final dose.


We found this trial at
1
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900 Northwest 17th Street
Miami, Florida 33136
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Miami, FL
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