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D.T. Wong, I. Siegel, S. Jain, K. Wong; PERC Study: An Open–Label Trial For Rheopheresis in Dry AMD Patients . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3543.
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The multicenter, double masked, placebo (sham–apheresis) controlled MIRA–1 study required patients to have documented significantly elevated macromolecules (Fibrinogen, IgA and total cholesterol); however evidence is mounting that patients having reduced acuity (20/32 to 20/125 ETDRS) and intermediate to large macular drusen, have similar outcomes following Rheopheresis even without testing for elevated macromolecules. This study is to determine if outcomes are similar without the inclusion requirement of elevated macromolecules.
PERC (Prospective Evaluation of Rheopheresis in Canada) is an open–label, 12 month trial including 30 eyes of patients seen at 3 month intervals with documented evidence of Dry AMD. This study did not require an inclusion criteria of elevated macromolecules. Tests including ETDRS BCVA, fundus evaluation, fluorescein angiography, digital color photography, OCT and Contrast Sensitivity were performed.
The BCVA change in vision results in PERC (30 eyes) with 6 month follow–up were compared to the same follow–up period in the MIRA–1 Interim Analysis published data (28 eyes). 40% and 48% of eyes respectively gained 1 line or more of vision; those gaining 2 or more lines were 20% and 28% respectively. Percent of patients entering the study with 20/50 or worse improving to 20/40 was 55% in PERC compared to 58% in MIRA. Patients that lost greater than or equal to 2 lines was 0% in PERC compared to 8% in the MIRA–1 trial. Vision was maintained or improved in 93% of PERC eyes compared to 92% in the MIRA–1 group.
For appropiate patients with dry AMD and without specific elevated macromolecules, Rheopheresis treated patients in the PERC study showed similar visual results as those from the interim analysis of the MIRA–1 study.
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