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Clinical Trials
November 2006

Ranibizumab Combined With Verteporfin Photodynamic Therapy in Neovascular Age-Related Macular DegenerationYear 1 Results of the FOCUS Study

Author Affiliations
 

ROY W.BECKMD, PhDAuthor Affiliations: Ophthalmic Consultants of Boston, Boston, Mass (Dr Heier); Retina Vitreous Associates Medical Group, Los Angeles, Calif (Dr Boyer); Midwest Eye Institute, Indianapolis, Ind (Dr Ciulla); Long Island Vitreoretinal Consultants, Great Neck, NY (Dr Ferrone); West Coast Retina Medical Group Inc, San Francisco, Calif (Dr Jumper); The New York Eye and Ear Infirmary, New York Medical College, Valhalla (Dr Gentile); and Genentech Inc, South San Francisco, Calif (Ms Kotlovker and Drs Chung and Kim).

Arch Ophthalmol. 2006;124(11):1532-1542. doi:10.1001/archopht.124.11.1532
Abstract

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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