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- Title
RheoNet -- An International Apheresis Registry for Rheopheresis: Update 2004.
- Authors
Klingel, R.; Fassbender, C.; Göhlen, B.; Wong, D.; Siegel, I.; Erdtracht, B.
- Abstract
Objective: RheoNet-registry was established to record Rheopheresis safety and efficacy data. Registry outcome analysis reference controlled by results of clinical trials represents a direct transfer of evidence-based medicine into clinical practice. For AMD two controlled randomized clinical trials demonstrated that 8 to 10 Rheopheresis treatments given over 10-21 weeks promote sustained improvement of the natural course of the dry form of the disease. The US multicenter, double masked placebo controlled MIRA-1-trial is ongoing to evaluate safety and efficacy of Rheopheresis for the treatment of dry AMD with soft drusen. Methods: RheoNet-registry is regularly analysed for safety aspects of Rheopheresis in centers and clinics performing treatments. Efficacy for AMD can be evaluated by analysis of the clinical data provided by ophthalmologists, which are responsible for indication and follow-up examination. Results: In March 2004 in total 3,314 Rheopheresis treatments of 529 pts., including 365 pts. with AMD, 115 pts. with sudden deafness/tinnitus (SD/T), 9 with ischemic diabetic foot syndrome, and 12 with critical limb ischemia were recorded. Mean age of treated pts. was 66 years (73.5 years for AMD). In 5.49 of treatments (all diagnoses) adverse events were reported, but only in 1.84% needed intervention, temporary break or discontinuation of the treatment. 18% of pts. were 80 years or older, but did not exhibit increased incidence of adverse events. AMD in general has an increased risk of retinal hemorrhage. 2 cases of retinal bleeding were reported within an interval of 14 days after Rheopheresis, which both caused no irreversible visual impairment. Ophthalmological data of 165 eyes of 118 AMD patients could be analyzed for this registry update including 149 eyes (108 pts.) with dry AMD, VA > 0.1 and 16 eyes (10 pts.) with pigment epithelial detachment. Patients received in mean 8.7 Rheopheresis treatments. For eyes with dry AMD, mean change in ETDRS-VA after Rheopheresis compared to baseline was +0.9 lines. For the group with PED, ETDRS-line change was +0.3. Conclusions: Based on interdisciplinary cooperation and quality management Rheopheresis can be regarded as a safe ambulatory treatment for patients for patients with microcirculatory disorders such as AMD or SD/T. Current RheoNet update for the group of patients with dry AMD essentially resembling inclusion criteria of controlled clinical trials showed results which were in good accordance with study data.
- Subjects
HEMAPHERESIS; DRUG dosage; DRUG side effects; RETINAL diseases; RETINAL (Visual pigment); RETINAL degeneration
- Publication
Kidney & Blood Pressure Research, 2004, Vol 27, Issue 5/6, p286
- ISSN
1420-4096
- Publication type
Article