| Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration: year 1 results of the FOCUS Study. | |
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MedLine Citation:
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PMID: 17101999 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To investigate the safety and efficacy of intravitreal ranibizumab treatment combined with verteporfin photodynamic therapy (PDT) in patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration. METHODS: In this 2-year, phase I/II, multicenter, randomized, single-masked, controlled study, patients received monthly ranibizumab (0.5 mg) (n = 106) or sham (n = 56) injections. The PDT was performed 7 days before initial ranibizumab or sham treatment and then quarterly as needed. MAIN OUTCOMES MEASURES: Proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months (primary efficacy outcome) and the incidence and severity of adverse events. RESULTS: At 12 months, 90.5% of the ranibizumab-treated patients and 67.9% of the control patients had lost fewer than 15 letters (P<.001). The most frequent ranibizumab-associated serious ocular adverse events were intraocular inflammation (11.4%) and endophthalmitis (1.9%; 4.8% if including presumed cases). On average, patients with serious inflammation had better visual acuity outcomes at 12 months than did controls. Key serious nonocular adverse events included myocardial infarctions in the PDT-alone group (3.6%) and cerebrovascular accidents in the ranibizumab-treated group (3.8%). CONCLUSION/APPLICATION TO CLINICAL PRACTICE: Ranibizumab + PDT was more efficacious than PDT alone for treating neovascular age-related macular degeneration. Although ranibizumab treatment increased the risk of serious intraocular inflammation, affected patients, on average, still experienced visual acuity benefit. |
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Authors:
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Jeffrey S Heier; David S Boyer; Thomas A Ciulla; Philip J Ferrone; J Michael Jumper; Ronald C Gentile; Debbi Kotlovker; Carol Y Chung; Robert Y Kim; |
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Publication Detail:
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Type: Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Archives of ophthalmology Volume: 124 ISSN: 0003-9950 ISO Abbreviation: Arch. Ophthalmol. Publication Date: 2006 Nov |
Date Detail:
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Created Date: 2006-11-14 Completed Date: 2006-12-04 Revised Date: 2007-01-22 |
Medline Journal Info:
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Nlm Unique ID: 7706534 Medline TA: Arch Ophthalmol Country: United States |
Other Details:
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Languages: eng Pagination: 1532-42 Citation Subset: AIM; IM |
Affiliation:
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Ophthalmic Consultants of Boston, Boston, MA 02114, USA. jsheier@eyeboston.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Angiogenesis Inhibitors / adverse effects, therapeutic use* Antibodies, Monoclonal / adverse effects, therapeutic use* Choroidal Neovascularization / drug therapy*, etiology Drug Therapy, Combination Female Humans Macular Degeneration / complications, drug therapy* Male Middle Aged Photochemotherapy* Photosensitizing Agents / adverse effects, therapeutic use* Porphyrins / adverse effects, therapeutic use* Prospective Studies Single-Blind Method Treatment Outcome Visual Acuity / physiology |
| Chemical | |
Reg. No./Substance:
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0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal; 0/Photosensitizing Agents; 0/Porphyrins; 0/ranibizumab; 129497-78-5/verteporfin |
| Comments/Corrections | |
Erratum In:
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Arch Ophthalmol. 2007 Jan;125(1):138 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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