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MIRA-1 - Multicenter Double Masked Placebo Controlled Trial of Rheopheresis in Dry AMD with Soft Drusen: Interim Analysis
1Klingel R., 2Sanders D., 3Pulido J.,
1Apherese Forschungsinstitut (Köln)
2Center for Clinical Research (Elmhurst)
3Department of Ophthalmology, University of Illinois (Chicago)
Purpose: Recently two controlled clinical trials demonstrated that 8 to 10 Rheopheresis treatments given over several months safely and effectively promote significant and sustained improvement in visual acuity and retinal function (Brunner et al., Retina 20:483-491, 2000; Swartz et al., IOVS 40: S319, 1999). Repetitive pulses of plasma protein elimination change the activity of promotors of the natural course of AMD development and progression. Goal of the Rheopheresis treatment is to restore and activate the functional reserve of the retina. Current knowledge of pathogenic mechanisms of the development and progression of AMD can be conclusively linked with the putative mechanism of action of Rheopheresis for AMD. Aim of this multicenter, double masked placebo controlled trial (MIRA-1) is to evaluate the safety and efficacy of Rheopheresis for the treatment of dry AMD with soft drusen.
Methods: 150 patients are to be randomized in a 2:1 ratio to receive 8 Rheopheresis or 8 placebo treatments over 10 weeks and followed for one year. Qualified patients have dry AMD with multiple large soft drusen, defined serum levels of targeted macromolecules and ETDRS-VAC 0.16-0.625.
Results: The interim analysis includes 43 subjects who have completed the 12 month follow up visit. In primary eyes the mean ETDRS-line difference at 12 months post baseline between treated and control group was 1.6 lines (p=0.0011, repeated measures analysis). The difference was significant throughout the first post-treatment year. 20% of eyes in the Rheopheresis vs. 9.1% in the placebo group had a ³ 2.5-line improvement in BCVA at 12 months post baseline. 4% of Rheopheresis vs. 18.2% of placebo eyes had a ³ 3-line loss in BCVA. Subgroup analysis indicated that eyes with baseline VAC worse than 0.5 derived the greatest treatment benefit at one year with mean difference of 3.0 ETDRS-lines compared to placebo (p=0.001). No severe treatment related adverse events occurred.
Conclusion: The Interim analysis of the MIRA-1 trial demonstrated statistically significant and clinically relevant effects of Rheopheresis on BCVAC when compared to placebo controls for the 12-month study interval.