Evidence map›Paper›PMID 24289920›Full record

Trial reportOphthalmology2014

Systemic complement inhibition with eculizumab for geographic atrophy in age-related macular degeneration: the COMPLETE study.

Zohar Yehoshua, Carlos Alexandre de Amorim Garcia Filho, Renata Portella Nunes, Giovanni Gregori, Fernando M Penha, Andrew A Moshfeghi, Kang Zhang, Srinivas Sadda, William Feuer, Philip J Rosenfeld

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Ophthalmology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00935883 (Eculizumab for the Treatment of Non-Exudative Age-Related Macular Degeneration), which is not on this map. Cited by 149 papers.

0numbers the graph read from it
0cells of the map it votes in
149citing papers in PubMed
18.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00935883 phase2completednot on this map

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

TypeinterventionalSponsorPhilip J. Rosenfeld, MD, PhDRan2009 to 2013Enrolled60ConditionsAge-Related Macular DegenerationArmsEculizumab, Saline
3 · Its place in the literature

Who cites it

149 citing papers in PubMed, 292 citations in OpenAlex.

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89 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Zohar YehoshuaDepartment of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Carlos Alexandre de Amorim Garcia FilhoDepartment of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Ophthalmology, Federal University of Säo Paulo, UNIFESP, São Paulo, Brazil.
Renata Portella NunesDepartment of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Giovanni GregoriDepartment of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Fernando M PenhaDepartment of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Ophthalmology, Federal University of Säo Paulo, UNIFESP, São Paulo, Brazil.
Andrew A MoshfeghiDepartment of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Kang ZhangInstitute for Genomic Medicine and Shiley Eye Center, University of California, San Diego, La Jolla, California.
Srinivas SaddaDoheny Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.
William FeuerDepartment of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Philip J RosenfeldDepartment of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: prosenfeld@med.miami.edu.
University of Miami · USUniversidade Federal de São Paulo · BRUniversity of California, San Diego · USUniversity of Southern California · US

Funding

Shared Equipment ModuleP30EY014801 · NEI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI Victor L Perez · 2004 to 2026
$12.2M
NEI NIH HHS P30 EY014801
6 · The paper itself

Abstract

purposeTo 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).

designProspective, double-masked, randomized clinical trial.

participantsPatients with GA measuring from 1.25 to 18 mm(2) based on spectral-domain optical coherence tomography imaging.

methodsPatients 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 measuresChange in area of GA at 26 weeks.

resultsThirty 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.

conclusionsSystemic complement inhibition with eculizumab was well tolerated through 6 months but did not decrease the growth rate of GA significantly. However, there was a statistically significant correlation between the low-luminance deficit at baseline and the progression of GA over 6 months.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, HumanizedComplement C5C-Reactive ProteinCreatinineDisease ProgressionDouble-Blind MethodEye ProteinsFemaleFluorescein AngiographyGeographic AtrophyHumansInfusions, IntravenousMalePolymorphism, Single NucleotideAntibodies, Monoclonal, HumanizedComplement C5C-Reactive ProteinCreatinineeculizumabEye Proteins

Identifiers

PMID24289920
PMCPMC4015213
OpenAlexW62535517

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.