PURPOSE: To present an initial evaluation of the final data from the Multicenter Investigation of Rheopheresisfor age-related macular degeneration (AMD) (MIRA-1) trial. This was a 12-month randomized, prospective, multicenter, double-masked, placebo-controlled, Food and Drug Administration approved clinical trial designed to compare rheopheresis treatment with placebo-control treatment. METHODS:Patients that had nonexudative age-related macular degeneration (AMD) and certain hemorheologic abnormalities were randomized to either rheopheresis or sham treatment in a 2:1 fashion. Best-corrected visual acuity was determined before and at 3, 6, 9, and 12 months following treatment. Adverse events were also recorded. RESULTS: A total of 216 patients were randomized. Of these, 18 were not included in the vision or adverse events evaluation because they did not complete one treatment. This decreased the number of patients that were evaluated for adverse events to 198 patients. In this group, there were 27 serious adverse events, but only 1.8 % of treatments were suspended because of adverse events. At 12 months, there were 104 treated patients and 63 placebo patients that had follow-up. The treated patients had a logMAR vision improvement of 0.02 +/- 0.213, and the placebo patients had a vision improvement of 0.02 +/- 0.20. This was not statistically significant (P = .977). The repeated measure P value for the entire time interval was not significant (P = .69). There appeared to be patients entered into the study that did not meet inclusion criteria. Excluding 37% of the treated patients and 29% of the placebo data from the analysis, there appeared to be statistically significant improvement in the treated patients compared to the control patients at 1 year with a P value of .001 (repeated measures P value = .01). CONCLUSIONS: At best this was a flawed study in that 37% of the treated cases did not meet inclusion criteria, and at worst there was no evidence of effect. Even though the number of serious adverse events is small, because this study did not show an effect in the intent-to-treat group, rheopheresis should not be performed for AMD outside of an approved randomized controlled trial.
RCT Entities:
PURPOSE: To present an initial evaluation of the final data from the Multicenter Investigation of Rheopheresis for age-related macular degeneration (AMD) (MIRA-1) trial. This was a 12-month randomized, prospective, multicenter, double-masked, placebo-controlled, Food and Drug Administration approved clinical trial designed to compare rheopheresis treatment with placebo-control treatment. METHODS:Patients that had nonexudative age-related macular degeneration (AMD) and certain hemorheologic abnormalities were randomized to either rheopheresis or sham treatment in a 2:1 fashion. Best-corrected visual acuity was determined before and at 3, 6, 9, and 12 months following treatment. Adverse events were also recorded. RESULTS: A total of 216 patients were randomized. Of these, 18 were not included in the vision or adverse events evaluation because they did not complete one treatment. This decreased the number of patients that were evaluated for adverse events to 198 patients. In this group, there were 27 serious adverse events, but only 1.8 % of treatments were suspended because of adverse events. At 12 months, there were 104 treated patients and 63 placebo patients that had follow-up. The treated patients had a logMAR vision improvement of 0.02 +/- 0.213, and the placebo patients had a vision improvement of 0.02 +/- 0.20. This was not statistically significant (P = .977). The repeated measure P value for the entire time interval was not significant (P = .69). There appeared to be patients entered into the study that did not meet inclusion criteria. Excluding 37% of the treated patients and 29% of the placebo data from the analysis, there appeared to be statistically significant improvement in the treated patients compared to the control patients at 1 year with a P value of .001 (repeated measures P value = .01). CONCLUSIONS: At best this was a flawed study in that 37% of the treated cases did not meet inclusion criteria, and at worst there was no evidence of effect. Even though the number of serious adverse events is small, because this study did not show an effect in the intent-to-treat group, rheopheresis should not be performed for AMD outside of an approved randomized controlled trial.
Authors: Michael Janusz Koss; Peter Kurz; Theoharis Tsobanelis; Walter Lehmacher; Cordula Fassbender; Reinhard Klingel; Frank H J Koch Journal: Graefes Arch Clin Exp Ophthalmol Date: 2009-07-23 Impact factor: 3.117
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 Studnička; Eva Rencová; Milan Bláha; Pavel Rozsíval; Miriam Lánská; Vladimír Bláha; Jan Němčanský; Hana Langrová Journal: J Ophthalmol Date: 2013-12-18 Impact factor: 1.909