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R.P. Gallemore, D.S. Boyer, E.L. Thomas, R.L. Novack, T.G. Chu; Adverse Events Associated with Rheophoresis for Treatment of Age-related Macular Degeneration (AMD) . Invest. Ophthalmol. Vis. Sci. 2003;44(13):1802.
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Purpose: To report the rates of adverse events associated with rheophoresis for treatment of dry AMD. Methods: As part of a FDA-approved, multicenter, randomized, controlled clinical trial, select patients with dry AMD (>10 soft drusen within 3000 um of the foveal center ) were randomized to the Rheophoresis Treatment group or the Placebo-Control group. Treatment related adverse events were reported on forms and tabulated at the study center. Results: A total of 40 adverse events, both treatment-related (5) and non-treatment-related (35), were recorded during 343 treatments and over the 12-month post-baseline interval for the 43 patients subject to the analysis [Rheopheresis (REO) n = 23; Placebo-Control (PC) n = 17]. The most common problem encountered in the trial population involved the establishment and maintenance of adequate peripheral venous access in the Rheopheresis group (17%, 38 of 223 procedures). The incidence of non-treatment-related adverse events was significantly lower in the Rheopheresis Treatment group (8.1%, 18 of 223) compared to the Placebo-Control group (14.2%, 17 of 120) (p = 0.03). The incidence of serious non-treatment-related events for Rheopheresis Treatment group (5 of 223, 2.2%) and the Placebo-Control group (2 of 120, 1.6%) were similar (p = 0.30). Treatment related adverse events were observed in 2.2% (5 of 223) of Rheopheresis procedures and in 0% (0 of120) of Placebo-Control treatments (p = 0.11). None of the 5 Rheopheresis-related events were serious and none were unanticipated. All 5 non-serious Rheopheresis-related events were associated with either transient or self-limited changes in intra-treatment blood pressure (hypotension, 2), fluid shifts (edema, 2) or vagal response (nausea, 1). No treatment-related hospitalizations or long-term treatment-related side effects or adverse events have been reported during this study. Conclusions: Rheophoresis was not assiciated with serious adverse tretament events in the present study. were observed in this study. The non-serious events were self limited and related in part to the to increased age of the patient populations. Establishing and maintaining venous access over a 2 to 4 hour extracorporeal procedure in elderly patients remains the most frequently encountered technical challenge. Rheophoresis is an acceptably safe modality of treatment.
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