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E. Reichel, M. Farah, J. P. Duprat, M. Avila, G. Y. Fujii, J. Rossi, A. Santos, B. Woodward, M. Yaqub, J. Nau; A Study to Evaluate the Safety and Feasibility of Radiotherapy and Bevacizumab (Avastin) for the Treatment of Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2007;48(13):3657.
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To evaluate the safety and efficacy of strontium-90 delivered concomitantly with bevacizumab (Avastin) injection for the treatment of subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
In this prospective clinical trial, 27 patients with subfoveal CNV were treated with a radiation dose of 24 Gy using the Epi-Rad90TM Ophthalmic System and two injections of bevacizumab (1.25 mg). Patients were randomized to two cohorts. Cohort A received bevacizumab ten days (+/- 4 days) prior to surgery and one month after surgery. Cohort B received bevacizumab at the time of surgery and one month after surgery. Safety and efficacy parameters were evaluated by measuring ETDRS best-corrected visual acuity, ocular examination, fluorescein angiography, and optical coherence tomography.
To date there have been no serious adverse events (SAE) associated with the use of the Epi-Rad90TM Ophthalmic System in this population. One week after treatment, mean visual acuity improved by +6.7 ETDRS letters in the study group. Six month data on ETDRS best-corrected visual acuity, fluorescein angiography, and OCT results will be presented.
Focal radiotherapy delivered concomitantly with anti-VEGF agents may provide a safe and effective alternative for patients with neovascular AMD. A large randomized prospective study is needed to fully determine the safety and efficacy of focal radiotherapy delivered concomitantly with anti-VEGF agents for the treatment of subfoveal CNV secondary to AMD.
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