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    
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.
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.
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.
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MeSH Terms
Angiogenesis Inhibitors / administration & dosage,  adverse effects*
Antibodies, Monoclonal, Humanized / administration & dosage,  adverse effects*
Cataract / chemically induced
Double-Blind Method
Follow-Up Studies
Intraocular Pressure / drug effects
Intravitreal Injections
Ocular Hypertension / chemically induced
Prospective Studies
Retinal Hemorrhage / chemically induced
Visual Acuity / drug effects,  physiology
Wet Macular Degeneration / drug therapy*,  physiopathology
Reg. No./Substance:
0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal, Humanized; 0/ranibizumab
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 /
Comment In:
Ophthalmology. 2013 Sep;120(9):e68-9   [PMID:  24001549 ]
Ophthalmology. 2013 Sep;120(9):e69   [PMID:  24001550 ]

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