30868
document
Preliminary analysis of the final multicenter investigation of rheopheresis for age related macular degeneration ( AMD ) trial ( MIRA-1 ) results . 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 .
30869
Intervention_Pharmacological
rheopheresis
30870
Intervention_Pharmacological
Rheopheresis
30871
Intervention_Control
placebo-controlled
30872
Intervention_Pharmacological
rheopheresis
30873
Intervention_Control
placebo-control
30874
Intervention_Pharmacological
rheopheresis
30875
Intervention_Pharmacological
sham treatment
30876
Intervention_Control
placebo
30877
Intervention_Control
placebo
30878
Intervention_Pharmacological
rheopheresis
30879
Outcome_Physical
vision
30880
Outcome_Adverse-effects
adverse events
30881
Outcome_Physical
logMAR vision improvement
30882
Outcome_Physical
vision improvement
30883
Participant_Condition
age related macular degeneration ( AMD )
30884
Participant_Condition
Patients that had nonexudative age-related macular degeneration ( AMD ) and certain hemorheologic abnormalities
30885
Participant_Condition
A total of 216 patients