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

Show simple item record

dc.contributor.author Yehoshua, Zohar
dc.contributor.author Garcia Filho, Carlos Alexandre de Amorim [UNIFESP]
dc.contributor.author Nunes, Renata Portella
dc.contributor.author Gregori, Giovanni
dc.contributor.author Penha, Fernando M. [UNIFESP]
dc.contributor.author Moshfeghi, Andrew A.
dc.contributor.author Zhang, Kang
dc.contributor.author Sadda, SriniVas
dc.contributor.author Feuer, William
dc.contributor.author Rosenfeld, Philip J.
dc.date.accessioned 2016-01-24T14:35:23Z
dc.date.available 2016-01-24T14:35:23Z
dc.date.issued 2014-03-01
dc.identifier http://dx.doi.org/10.1016/j.ophtha.2013.09.044
dc.identifier.citation Ophthalmology. New York: Elsevier B.V., v. 121, n. 3, p. 693-701, 2014.
dc.identifier.issn 0161-6420
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/37497
dc.description.abstract Purpose: 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.sponsorship Alexion Pharmaceuticals
dc.description.sponsorship Macula Vision Research Foundation
dc.description.sponsorship Carl Zeiss Meditec, Inc., Dublin, California
dc.description.sponsorship Research to Prevent Blindness, Inc., New York, New York
dc.description.sponsorship National Eye Institute, National Institutes of Health, Bethesda, Maryland
dc.description.sponsorship Department of Defense, Washington, DC
dc.description.sponsorship Jerome A. Yavitz Charitable Foundation
dc.description.sponsorship Emma Clyde Hodge Memorial Foundation
dc.description.sponsorship Florman Family Foundation, Inc.
dc.description.sponsorship Gemcon Family Foundation
dc.format.extent 693-701
dc.language.iso eng
dc.publisher Elsevier B.V.
dc.relation.ispartof Ophthalmology
dc.rights Acesso restrito
dc.title Systemic Complement Inhibition with Eculizumab for Geographic Atrophy in Age-Related Macular Degeneration en
dc.type Artigo
dc.rights.license http://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dc.contributor.institution Univ Miami
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.contributor.institution Univ Calif San Diego
dc.contributor.institution Univ So Calif
dc.description.affiliation Univ Miami, Miller Sch Med, Bascom Palmer Eye Inst, Dept Ophthalmol, Miami, FL 33136 USA
dc.description.affiliation Universidade Federal de São Paulo, UNIFESP, Dept Ophthalmol, São Paulo, Brazil
dc.description.affiliation Univ Calif San Diego, Inst Genom Med, La Jolla, CA 92093 USA
dc.description.affiliation Univ Calif San Diego, Shiley Eye Ctr, La Jolla, CA 92093 USA
dc.description.affiliation Univ So Calif, Keck Sch Med, Doheny Eye Inst, Los Angeles, CA 90033 USA
dc.description.affiliationUnifesp Universidade Federal de São Paulo, UNIFESP, Dept Ophthalmol, São Paulo, Brazil
dc.description.sponsorshipID National Eye Institute, National Institutes of Health, Bethesda, Maryland: P30 EY014801
dc.description.sponsorshipID Department of Defense, Washington, DC: W81XWH-09-10675
dc.identifier.doi 10.1016/j.ophtha.2013.09.044
dc.description.source Web of Science
dc.identifier.wos WOS:000332401800019



File

File Size Format View

There are no files associated with this item.

This item appears in the following Collection(s)

Show simple item record

Search


Browse

Statistics

My Account