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R.G. Klingel, D. Wong, C. Fassbender, A. Heibges, B. Erdtracht, International Rheopheresis Centers; Rheopheresis for Dry Age–Related Macular Degeneration (AMD) – RheoNet–Registry Update 2005/06 . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2179.
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Rheopheresis is a method of therapeutic apheresis to treat microcirculatory disorders. 2 controlled randomized clinical trials demonstrated that 8–10 treatments over 10–21 weeks result in sustained improvement of the natural course of dry AMD. Final results of the MIRA–1–multicenter trial on safety and efficacy of Rheopheresis for dry AMD with soft drusen are in preparation. Rheopheresis has been approved by medical device regulations in Germany and Canada, and is available for high–risk AMD patients, who otherwise don’t have alternative therapeutic options. RheoNet–registry was established for quality management of Rheopheresis including an independent data safety and monitoring board.
RheoNet is regularly analysed for safety aspects based on reports of treatment centers, and efficacy for AMD based on data provided by ophthalmologists responsible for indication and follow–up examination. Reports of adverse events (AE) or vascular access problems are classified by clinical relevance (class I: all reports, class II: all reports of class I followed by an intervention, class III: all reports of class II, which necessitated termination of treatment. Serious adverse events (SAE) are part of class III.
In November 2005 in total 5554 Rheopheresis treatments of 867 pts., including 606 pts. with AMD, and 261 pts. with other microcirculatory disorders were recorded. Mean age of treated AMD pts. was 75 yrs.. In 6.8% of treatments of AMD pts. AE were reported, but only in 0.56% were followed by termination of the treatment (i.e. class III). No SAE occurred. 23% of pts. were 80 yrs. or older, but did not exhibit increased incidence of AE. Transient hypotension was the most frequently reported AE but was class III in only 0.31%. Problems with the peripheral vascular access only in 0.86% did'nt allow complete treatment. Ophthalmological data of 291 eyes of 201 AMD pts. could be analyzed for this registry update. Pts. received in mean 8.3 Rheopheresis treatments. For eyes with dry AMD, mean change in ETDRS–BCVA after Rheopheresis compared to baseline was +0.8 lines. Partner eyes might have been late stages with wet AMD, but did not exhibit bleeding complications.
Rheopheresis is a safe ambulatory treatment for elderly patients with AMD. Results of current RheoNet analysis are in good accord with MIRA–1 interim results at 12 months (0.7 line gain in the Rheopheresis group vs. 0.9 line loss in the control group).
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