| Verteporfin plus Ranibizumab for Choroidal Neovascularization in Age-related Macular Degeneration: Twelve-month MONT BLANC Study Results. | |
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MedLine Citation:
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PMID: 22424834 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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PURPOSE: To compare the efficacy and safety of same-day verteporfin photodynamic therapy (PDT) and intravitreal ranibizumab combination treatment versus ranibizumab monotherapy in neovascular age-related macular degeneration. DESIGN: Prospective, multicenter, double-masked, randomized, active-controlled trial. PARTICIPANTS: We included 255 patients with all types of active subfoveal choroidal neovascularization. METHODS: Patients were randomized 1:1 to as-needed (pro re nata; PRN) combination (standard-fluence verteporfin 6 mg/m(2) PDT and ranibizumab 0.5 mg) or PRN ranibizumab monotherapy (sham infusion [5% dextrose] PDT and ranibizumab 0.5 mg). Patients received 3 consecutive monthly injections followed by PRN retreatments based on protocol-specific retreatment criteria. MAIN OUTCOME MEASURES: Mean change in best-corrected visual acuity (BCVA) from baseline to month 12, and the proportion of patients with treatment-free interval ≥3 months at any timepoint after month 2. RESULTS: The mean change in BCVA at month 12 was +2.5 and +4.4 letters in the combination and monotherapy groups, respectively (P = 0.0048; difference: -1.9 letters [95% confidence interval, -5.76 to 1.86], for having achieved noninferiority with a margin of 7 letters). The proportion of patients with a treatment-free interval of ≥3 months at any timepoint after month 2 was high, but did not show a clinically relevant difference between the treatment groups. Secondary efficacy endpoints included the mean number of ranibizumab retreatments after month 2 (1.9 and 2.2 with combination and monotherapy, respectively [P = 0.1373]). The time to first ranibizumab retreatment after month 2 was delayed by 34 days (about 1 monthly visit) with combination (month 6) versus monotherapy (month 5). At month 12, mean ± standard error central retinal thickness decreased by 115.3±9.04 μm in the combination group and 107.7±11.02 μm in the monotherapy group. The mean number of verteporfin/sham PDT treatments was comparable in the 2 groups (combination, 1.7; monotherapy, 1.9). The safety profiles of the 2 groups were comparable, with a low incidence of ocular serious adverse events. CONCLUSIONS: The combination PRN treatment regimen with verteporfin PDT and ranibizumab was effective in achieving BCVA gain comparable with ranibizumab monotherapy; however, the study did not show benefits with respect to reducing the number of ranibizumab retreatment over 12 months. The combination therapy was well tolerated. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosures may be found after the references. |
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Authors:
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Michael Larsen; Ursula Schmidt-Erfurth; Paolo Lanzetta; Sebastian Wolf; Christian Simader; Erika Tokaji; Stefan Pilz; Annemarie Weisberger; |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-3-16 |
Journal Detail:
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Title: Ophthalmology Volume: - ISSN: 1549-4713 ISO Abbreviation: - Publication Date: 2012 Mar |
Date Detail:
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Created Date: 2012-3-19 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7802443 Medline TA: Ophthalmology Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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