PURPOSE: To evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders. METHODS: The dry AMD treatment with Rheopheresis trial (ART) was a randomised, controlled clinical study. Patients with the diagnosis of AMD in both eyes, with the study eye presenting dry AMD and soft drusen (the fellow eye had advanced AMD) were randomly assigned in a 1:1 ratio to receive ten Rheopheresis treatments within 17 weeks or to remain untreated. The primary outcome was change in best-corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups. RESULTS:Forty-three eyes of 43 patients (22 treatment and 21 control group) were analysed. The mean baseline BCVA in study eyes was 0.58 in the treatment group and 0.66 in the control group (n.s. p = 0.19). At the primary efficacy endpoint 7.5 months post baseline, there was a statistically significant mean difference of 0.95 ETDRS lines (p = 0.01) between the Rheopheresis and control groups. Nine percent of eyes in the group treated with Rheopheresis gained 2 or more ETDRS lines, as compared with 0% of eyes with no treatment. None of the treated patients had a loss in visual acuity in their study eyes, as compared with 24% of patients without treatment who lost 1 ETDRS line or more; 19% lost 2 ETDRS lines or more. Rheopheresis treatment was safe and well-tolerated. CONCLUSION: The results of ART provide further evidence that Rheopheresis is a safe and effective therapeutic option for high-risk patients with dry AMD and no therapeutic alternative. A series of Rheopheresis treatments can improve the natural course of AMD for selected patients.
RCT Entities:
PURPOSE: To evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders. METHODS: The dry AMD treatment with Rheopheresis trial (ART) was a randomised, controlled clinical study. Patients with the diagnosis of AMD in both eyes, with the study eye presenting dry AMD and soft drusen (the fellow eye had advanced AMD) were randomly assigned in a 1:1 ratio to receive ten Rheopheresis treatments within 17 weeks or to remain untreated. The primary outcome was change in best-corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups. RESULTS: Forty-three eyes of 43 patients (22 treatment and 21 control group) were analysed. The mean baseline BCVA in study eyes was 0.58 in the treatment group and 0.66 in the control group (n.s. p = 0.19). At the primary efficacy endpoint 7.5 months post baseline, there was a statistically significant mean difference of 0.95 ETDRS lines (p = 0.01) between the Rheopheresis and control groups. Nine percent of eyes in the group treated with Rheopheresis gained 2 or more ETDRS lines, as compared with 0% of eyes with no treatment. None of the treated patients had a loss in visual acuity in their study eyes, as compared with 24% of patients without treatment who lost 1 ETDRS line or more; 19% lost 2 ETDRS lines or more. Rheopheresis treatment was safe and well-tolerated. CONCLUSION: The results of ART provide further evidence that Rheopheresis is a safe and effective therapeutic option for high-risk patients with dry AMD and no therapeutic alternative. A series of Rheopheresis treatments can improve the natural course of AMD for selected patients.
Authors: Tien Y Wong; Tien Wong; Usha Chakravarthy; Ronald Klein; Paul Mitchell; Gergana Zlateva; Ronald Buggage; Kyle Fahrbach; Corey Probst; Isabella Sledge Journal: Ophthalmology Date: 2007-08-06 Impact factor: 12.079
Authors: C C Klaver; J J Assink; R van Leeuwen; R C Wolfs; J R Vingerling; T Stijnen; A Hofman; P T de Jong Journal: Invest Ophthalmol Vis Sci Date: 2001-09 Impact factor: 4.799
Authors: Eva Rencová; Milan Bláha; Jan Studnička; Vladimír Bláha; Miriam Lánská; Ondřej Renc; Alexander Stepanov; Věra Kratochvílová; Hana Langrová Journal: J Ophthalmol Date: 2015-08-17 Impact factor: 1.909
Authors: Jan-Gerd Rademacher; Björn Tampe; Angela Borisch; Rosa Marie Buschfort; Andrea von Figura; Thomas Asendorf; Peter Korsten Journal: Front Med (Lausanne) Date: 2022-04-14
Authors: Milan Košťál; Milan Bláha; Eva Rencová; Miriam Lánská; Pavel Rozsíval; Vera Kratochvilová; Hana Langrová Journal: Biomed Res Int Date: 2014-03-06 Impact factor: 3.411