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Reference Controlled RheoNet Registry Analysis of Patients with Dry AMD and Soft Drusen Treated with Rheopheresis
1Fassbender C., 2van Hasselt K., 3Weickert C., 4Hofstetter H.-J., 5Engelmann K., 6Koch F., 1Klingel R.,
1Apherese Forschungsinstitut (Köln)
2Ophthalmologisches Zentrum (Köln)
3Ophthalmologisches Institut (Ingelheim)
4Ophthalmologisches Institut (Bad Kissingen)
5Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde (Hamburg)
6Johann-Wolfgang-Goethe-Universität, Klinik für Augenheilkunde, Netzhaut- und Glaskörperchirurgie (Frankfurt/Main)
Purpose: Recently the interim analysis of a multicenter randomized, placebo controlled, double masked US study (MIRA-1) demonstrated a significant treatment effect of Rheopheresis compared to placebo for patients with dry AMD and soft drusen at 12 months. Safety and efficacy of Rheopheresis for AMD was shown earlier in two controlled clinical trials (Brunner et al., Retina 20:483-491, 2000; Swartz et al., IOVS 40: S319, 1999). Goal of the Rheopheresis treatment is to restore or stabilize the functional reserve of the retina affected by AMD which is determined by the individual pattern of reversible and irreversible morphologic changes. The RheoNet, an international Rheopheresis registry, was established as instrument of quality management. Here we report on a current RheoNet registry analysis of selected patients.
Methods: 27 eyes with dry AMD and soft drusen of 18 Patients were analyzed after completion of the initial treatment series. The initial BCVAC was 0.1 - 0.8. In total 160 Rheopheresis treatments were performed in cooperation with 5 Rheopheresis competence centers*. BCVAC was assessed with ETDRS-charts at baseline and after the treatment series.
Results: Patients received in mean 8.8 treatments within 18.3 weeks. Rheopheresis was safe and well tolerated. Compared to baseline ETDRS BCVAC 37 % of eyes had a ³ 2-line, 44 % a 1-line improvement. 15 % of patients did not change in VAC, 4 % had a 1-line, 0 % a ³ 2-line loss. The mean change in VAC was 1.26 ETDRS-lines. In comparison, interim results of the MIRA-1 study revealed 3 months post baseline in 28.6 % of treated eyes an improvement of ³ 2-lines compared to only 6.7 % of the eyes in the placebo group. The mean line change was 1.2 at that time.
Conclusions: This reference controlled registry analysis is in good accordance with the results of 3 controlled clinical trials and demonstrates the potential of Rheopheresis as a novel treatment for patients with dry AMD and soft drusen.
*Medical directors: R. Blum, Bad Neustadt, B. Erdtracht, Köln, F. Himmelsbach, Ingelheim, P. Kurz u. Th. Tsobanelis, Frankfurt, W. Wahls, Hamburg.