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RL Davis; Interim Safety Analysis of a Multicenter Randomized Prospective Double Masked Placebo Controlled Trial of Apheresis in Pre-Angiogenic Age-Related Macular Degeneration (AMD) . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2536.
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Purpose: This trial evaluates the safety and efficacy of Rheopheresis blood filtration in subjects with Dry AMD. Methods: At this analysis, 43 subjects had been randomized to Rheopheresis (28) or Placebo (15) groups and had completed the 12-month follow up visit. Subjects received 343 double-masked treatments. Vascular access was obtained via bilateral antecubital venipuncture. Safety was evaluated by documenting evidence of adverse events. For each event the: dates of onset and resolution, severity, whether it was treatment-related, non-treatment-related, serious or non-serious, action or treatment required and the outcomes were recorded. Interim statistical analysis: Fischer's Exact Test compared incidence of total events in the study groups. Results: 40 adverse events (Rheopheresis - 23, Placebo - 17), both treatment-related, 5, and non-treatment-related, 35, were recorded. 17% (38 of 223) of Rheopheresis procedures encountered difficulties with venous access. Safety outcomes included episodes of parasthesisas, hypotension, nausea, edema, and others. Treatment-related adverse events were observed in 2.2% (5 of 223) of Rheopheresis procedures and in 0% (0 of120) of Placebo treatments (p=0.11). None (0 of 5) were serious. The 5 non-serious events included: hypotension (2), edema (2) and nausea (1). The incidence of non-treatment-related events was significantly greater (p=0.03) in Placebo subjects (17 in 120, 14.2%) compared to Rheopheresis subjects (18 in 223, 8.0%). The rates of serious non-treatment-related events for the 2 groups were similar (2.2% and 1.6% respectively, p=0.11). 2 distant deaths (suicide, Leukemia) occurred in the Rheopheresis group. Both occurred between the 9 and 12-month post-baseline interval. No deaths occurred in the Placebo group. No long-term treatment-related side effects, or adverse events were reported. Conclusion: This 12-month interval interim analysis demonstrates that Rheopheresis as a treatment for select patients with pre-angiogenic AMD appears to be safe and well tolerated. Adverse event rates are low were typically non-serious and self-limited. Peripheral venous access in elderly patients remains the most frequent technical challenge. These early results should stimulate further research into the use of Rheopheresis for subjects with AMD.
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