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| |  Triple Therapy for Age-Related Macular Degeneration Benefits Some, Not All Patients: Presented at ARVO By Cameron Johnston FT. LAUDERDALE, Fla -- May 13, 2009 -- Patients with choroidal neovascularisation secondary to age-related macular degeneration (AMD) who are treated with bevacizumab plus photodynamic therapy (PDT) and triamcinolone require fewer treatments over the course of a year than patients who receive bevacizumab alone, researchers stated here at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting. However, the combination therapy does not appear to result in any improvement in visual outcomes compared with monotherapy. Choroidal neovascularisation is a multifactorial process, and therefore requires treatments that address each facet of the disease, explained Tom Sheidow MD, Schulich School of Medicine and Dentistry, University of Western Ontario, and Ivey Eye Institute of Ophthalmology, London, Ontario, on May 4. While anti-vascular endothelial growth factor inhibitor (VEGF) drugs prevent the formation of new blood vessels in the retina, they do nothing to remove blood vessels that have already formed. PDT, on the other hand, eradicates existing neovascularisation but causes inflammation and the release of VEGF, thereby contributing to new blood vessel growth. This requires treatment with an anti-inflammatory agent such as triamcinolone. The study involved 3 groups of patients. Thirty-five were treated with bevacizumab 1.25 mg at baseline, then as needed for another 48 weeks; 33 were treated with bevacizumab plus PDT as needed; and 35 received bevacizumab plus PDT, plus intravitreal triamcinolone, as needed. All patients were evaluated at 6-week intervals. The decision to offer any form of additional treatment was based on whether or not there was retinal thickening, as seen on optical coherence tomography (OCT), or increased neovascularisation as shown on fluorescein angiography. The primary endpoint of the study was to determine whether patients who received the double or triple therapy combinations would require fewer treatments throughout the year, compared with patients who received monotherapy with bevacizumab, as needed. Patients who received triple therapy required a mean of 3.18 treatments per year, while those receiving bevacizumab plus PDT required 3.39 treatments, and those receiving bevacizumab monotherapy required 4.57 treatments. The mean length of time between treatments was 75 days for patients treated with bevacizumab alone, 102 days for patients receiving double therapy, and 98 days for those receiving triple therapy. These results were statistically significant. Of the patients in the double therapy arm, 40% required only 2 injections over 48 weeks, compared with 30% of patients in the triple-therapy group. While approximately one-quarter of patients in each arm experienced a gain in visual acuity of >=1.5 ETDRS (Early Treatment Diabetic Retinopathy Study) letters, the between-group differences were not statistically significant. Dr. Sheidow commented that double or triple therapy might not have the same benefit for everyone, and that improvements seen in visual acuity are highly variable. However, these are useful treatment options that may make it possible for many patients to have fewer treatments each year. Patient convenience and cost are 2 important factors that have to be considered when offering these treatments to many patients, he said. [Presentation title: Combination Therapy in Neovascular Age-Related Macular Degeneration (amd): A Three-Armed, Randomized, Prospective Clinical Trial of Low Fluence Photodynamic Therapy (rpdt) With Adjunctive Avastin and Triamcinolone Acetonide (Kenalog)(Triple Therapy) Versus Rpdt With Adjunctive Avastin (Double Therapy) versus Monotherapy With Avastin. Abstract 1922-A612]
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