Document Detail


The SECURE study: long-term safety of ranibizumab 0.5 mg in neovascular age-related macular degeneration.
MedLine Citation:
PMID:  23021093     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration (nAMD).
DESIGN: Twenty-four-month, open-label, multicenter, phase IV extension study.
PARTICIPANTS: Two hundred thirty-four patients previously treated with ranibizumab for 12 months in the EXCITE/SUSTAIN study.
METHODS: Ranibizumab 0.5 mg administered at the investigator's discretion as per the European summary of product characteristics 2007 (SmPC, i.e., ranibizumab was administered if a patient experienced a best-corrected visual acuity [BCVA] loss of >5 Early Treatment Diabetic Retinopathy Study letters measured against the highest visual acuity [VA] value obtained in SECURE or previous studies [EXCITE and SUSTAIN], attributable to the presence or progression of active nAMD in the investigator's opinion).
MAIN OUTCOME MEASURES: Incidence of ocular or nonocular adverse events (AEs) and serious AEs, mean change in BCVA from baseline over time, and the number of injections.
RESULTS: Of 234 enrolled patients, 210 (89.7%) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months. Approximately 42% of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8%; 1 event related to study drug), cataract (11.5%; 1 event related to treatment procedure), and increased intraocular pressure (6.4%; 1 event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6% of patients; none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0% each). Arterial thromboembolic events were reported in 5.6% of the patients. Five (2.1%) deaths occurred during the study, none related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline.
CONCLUSIONS: The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the European ranibizumab SmPC at the investigator's discretion was well tolerated over 2 years. No new safety signals were identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study baseline, which may be the result of disease progression or possible undertreatment.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
Authors:
Rufino Silva; Ruth Axer-Siegel; Bora Eldem; Robyn Guymer; Bernd Kirchhof; Andras Papp; Andras Seres; Margarita Gekkieva; Annette Nieweg; Stefan Pilz;
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Publication Detail:
Type:  Clinical Trial, Phase IV; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-09-25
Journal Detail:
Title:  Ophthalmology     Volume:  120     ISSN:  1549-4713     ISO Abbreviation:  Ophthalmology     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-03     Completed Date:  2013-03-07     Revised Date:  2013-10-16    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  130-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Ophthalmology, Coimbra University Hospital, Faculty of Medicine, University of Coimbra, and Association for Innovation and Biomedical Research on Light and Image (AIBILI), Coimbra, Portugal. rufino.silva@oftalmologia.co.pt
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00504959
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MeSH Terms
Descriptor/Qualifier:
Aged
Angiogenesis Inhibitors / administration & dosage,  adverse effects*
Antibodies, Monoclonal, Humanized / administration & dosage,  adverse effects*
Cataract / chemically induced
Double-Blind Method
Female
Follow-Up Studies
Humans
Intraocular Pressure / drug effects
Intravitreal Injections
Male
Ocular Hypertension / chemically induced
Prospective Studies
Retinal Hemorrhage / chemically induced
Visual Acuity / drug effects,  physiology
Wet Macular Degeneration / drug therapy*,  physiopathology
Chemical
Reg. No./Substance:
0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal, Humanized; 0/ranibizumab
Investigator
Investigator/Affiliation:
Anita Leys / ; Jean-Marie Rakic / ; Laurence Postelmans / ; Robyn Guymer / ; Andras Papp / ; Andrea Facsko / ; Andras Seres / ; Rufino Silva / ; F Falcão Reis / ; R O Schlingemann / ; C P Hoyng / ; Ricardo Casaroli / ; Carlos Mateo / ; Amparo Navea Tejerina / ; Enrique Cervera / ; Jose Ruiz Moreno / ; Juan Donate Lopez / ; Francisco Gomez Ulla / ; Felix Armada / ; Yit-Chuijn Yang / ; Clare Bailey / ; Andrew Lotery / ; Jon Gibson / ; Peter Wiedemann / ; Karl-Ulrich Bartz-Schmidt / ; Katrin Engelmann / ; Frank Holz / ; Anselm Kampik / ; Ulrich Kellner / ; Bernd Kirchhof / ; Klaus Lemmen / ; Stefan Mennel / ; Andreas Mohr / ; Johann Roider / ; Rainer Guthoff / ; Michael Foerster / ; Joseph Moisseiev / ; Michaela Goldstein / ; Ruth Axer-Siegel / ; Bora Eldem / ; Emin Ozmert /
Comments/Corrections
Comment In:
Ophthalmology. 2013 Sep;120(9):e68-9   [PMID:  24001549 ]
Ophthalmology. 2013 Sep;120(9):e69   [PMID:  24001550 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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