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Title: Change in Drusen Volume as a Novel Clinical Trial Endpoint for the Study of Complement Inhibition in Age-related Macular Degeneration
Authors: Garcia Filho, Carlos Alexandre de Amorim [UNIFESP]
Yehoshua, Zohar
Gregori, Giovanni
Nunes, Renata Portella [UNIFESP]
Penha, Fernando Marcondes [UNIFESP]
Moshfeghi, Andrew A.
Zhang, Kang
Feuer, William
Rosenfeld, Philip J.
Univ Miami
Universidade Federal de São Paulo (UNIFESP)
Univ Calif San Diego
Issue Date: 1-Jan-2014
Publisher: Slack Inc
Citation: Ophthalmic Surgery Lasers & Imaging. Thorofare: Slack Inc, v. 45, n. 1, p. 18-31, 2014.
Abstract: BACKGROUND and OBJECTIVE: To evaluate the change in drusen volume following treatment with eculizumab, a systemic inhibitor of complement component 5.PATIENTS and METHODS: Single-center, prospective, randomized, double-masked clinical trial. Patients were randomized 2: 1 to receive intravenous eculizumab or placebo over 26 weeks. Main outcome measure: decrease in drusen volume of at least 50% at 26-week follow-up.RESULTS: Mean drusen cube root volumes were 0.49 mm and 0.47 mm (P=.64) at baseline and 0.51 mm and 0.42 mm (P=.17) at 26 weeks in the eculizumab and placebo groups, respectively. in the placebo group, one eye had a decrease in drusen volume of at least 50% and two eyes developed neovascularization through 26 weeks.CONCLUSION: Systemic complement inhibition with eculizumab did not significantly reduce drusen volume. Drusen growth was dependent on the number of complement at-risk alleles. Future trials should consider the use of a composite clinical trial endpoint in which efficacy is defined by the treatment's ability to prevent drusen growth, neovascularization, and the formation of geographic atrophy over 1 year.
ISSN: 1542-8877
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