Systemic Complement Inhibition with Eculizumab for Geographic Atrophy in Age-Related Macular Degeneration

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dc.contributor.authorYehoshua, Zohar
dc.contributor.authorGarcia Filho, Carlos Alexandre de Amorim [UNIFESP]
dc.contributor.authorNunes, Renata Portella
dc.contributor.authorGregori, Giovanni
dc.contributor.authorPenha, Fernando M. [UNIFESP]
dc.contributor.authorMoshfeghi, Andrew A.
dc.contributor.authorZhang, Kang
dc.contributor.authorSadda, SriniVas
dc.contributor.authorFeuer, William
dc.contributor.authorRosenfeld, Philip J.
dc.contributor.institutionUniv Miami
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionUniv Calif San Diego
dc.contributor.institutionUniv So Calif
dc.date.accessioned2016-01-24T14:35:23Z
dc.date.available2016-01-24T14:35:23Z
dc.date.issued2014-03-01
dc.description.abstractPurpose: To evaluate the effect of eculizumab, a systemic inhibitor of complement component (C5), on the growth of geographic atrophy (GA) in patients with age-related macular degeneration (AMD).Design: Prospective, double-masked, randomized clinical trial.Participants: Patients with GA measuring from 1.25 to 18 mm(2) based on spectral-domain optical coherence tomography imaging.Methods: Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 6 months. in the eculizumab treatment arm, the first 10 patients received a low-dose regimen of 600 mg weekly for 4 weeks followed by 900 mg every 2 weeks until week 24, and the next 10 patients received a high-dose regimen of 900 mg weekly for 4 weeks followed by 1200 mg every 2 weeks until week 24. the placebo group was infused with saline. Patients were observed off treatment for an additional 26 weeks. Both normal-luminance and low-luminance visual acuities were measured throughout the study, and the low-luminance deficits were calculated as the difference between the letter scores.Main Outcome Measures: Change in area of GA at 26 weeks.Results: Thirty eyes of 30 patients were enrolled. Eighteen fellow eyes also met inclusion criteria and were analyzed as a secondary endpoint. for the 30 study eyes, mean square root of GA area measurements +/-standard deviation at baseline were 2.55+/-0.94 and 2.02+/-0.74 mm in the eculizumab and placebo groups, respectively (P = 0.13). At 26 weeks, GA enlarged by a mean of 0.19+/-0.12 and 0.18+/-0.15 mm in the eculizumab and placebo groups, respectively (P = 0.96). At 52 weeks of follow-up, GA enlarged by a mean of 0.37+/-0.22 mm in the eculizumab-treated eyes and by a mean of 0.37+/-0.21 mm in the placebo group (P = 0.93, 2 sample t test). None of the eyes converted to wet AMD. No drug-related adverse events were identified.Conclusions: Systemic complement inhibition with eculizumab was well tolerated through 6 months but did not decrease the growth rate ofGAsignificantly. However, there was a statistically significant correlation between the low-luminance deficit at baseline and the progression of GA over 6 months. (C) 2014 by the American Academy of Ophthalmology.en
dc.description.affiliationUniv Miami, Miller Sch Med, Bascom Palmer Eye Inst, Dept Ophthalmol, Miami, FL 33136 USA
dc.description.affiliationUniversidade Federal de São Paulo, UNIFESP, Dept Ophthalmol, São Paulo, Brazil
dc.description.affiliationUniv Calif San Diego, Inst Genom Med, La Jolla, CA 92093 USA
dc.description.affiliationUniv Calif San Diego, Shiley Eye Ctr, La Jolla, CA 92093 USA
dc.description.affiliationUniv So Calif, Keck Sch Med, Doheny Eye Inst, Los Angeles, CA 90033 USA
dc.description.affiliationUnifespUniversidade Federal de São Paulo, UNIFESP, Dept Ophthalmol, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipAlexion Pharmaceuticals
dc.description.sponsorshipMacula Vision Research Foundation
dc.description.sponsorshipCarl Zeiss Meditec, Inc., Dublin, California
dc.description.sponsorshipResearch to Prevent Blindness, Inc., New York, New York
dc.description.sponsorshipNational Eye Institute, National Institutes of Health, Bethesda, Maryland
dc.description.sponsorshipDepartment of Defense, Washington, DC
dc.description.sponsorshipJerome A. Yavitz Charitable Foundation
dc.description.sponsorshipEmma Clyde Hodge Memorial Foundation
dc.description.sponsorshipFlorman Family Foundation, Inc.
dc.description.sponsorshipGemcon Family Foundation
dc.description.sponsorshipIDNational Eye Institute, National Institutes of Health, Bethesda, Maryland: P30 EY014801
dc.description.sponsorshipIDDepartment of Defense, Washington, DC: W81XWH-09-10675
dc.format.extent693-701
dc.identifierhttp://dx.doi.org/10.1016/j.ophtha.2013.09.044
dc.identifier.citationOphthalmology. New York: Elsevier B.V., v. 121, n. 3, p. 693-701, 2014.
dc.identifier.doi10.1016/j.ophtha.2013.09.044
dc.identifier.issn0161-6420
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/37497
dc.identifier.wosWOS:000332401800019
dc.language.isoeng
dc.publisherElsevier B.V.
dc.relation.ispartofOphthalmology
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dc.titleSystemic Complement Inhibition with Eculizumab for Geographic Atrophy in Age-Related Macular Degenerationen
dc.typeinfo:eu-repo/semantics/article
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