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RP Danis, LJ McCarthy, A Harris, TA Ciulla, L Kageman, LM Pratt; Interim Results of a Multicenter Double Masked Placebo Controlled Trial of Apheresis in Pre-angiogenic Age-related Macular Degeneration (ARMD) . Invest. Ophthalmol. Vis. Sci. 2002;43(13):1210.
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Purpose: This multicenter phase III clinical trial evaluates the safety and efficacy of apheresis (RheopheresisTM), an extracorporeal blood filtration procedure, in subjects with pre-angiogenic ARMD. Methods:150 subjects are to be randomized into apheresis treatment or placebo control in a 2:1 ratio and followed clinically for one year among up to 12 centers. Qualified subjects have an area of soft drusen ≥ 31,000 um2, elevated blood levels of certain hemorheologic factors and ETDRS visual acuity between 20/32 and 20/125 inclusive. To date, 43 subjects have completed the 12-month follow up visit. Interim analysis includes three groups: all of the study eyes (n=43), all of the qualifying eyes that met entry criteria (study eyes and fellow eyes, n=54), and all eyes of all subjects (n=85). Statistical analysis compared treated and control groups using repeated measures ANOVA of best corrected ETDRS visual acuity acquired at 3, 6, 9, and 12 month post baseline visits. Results:The three groups of eyes demonstrate a significant treatment effect at 12 months. The mean difference between treated and control groups is 1.6 ETDRS lines in the primary group (p=0.001), 1.5 in the all qualifying eyes group (p=0.005), and 1.7 in the all eyes group (p=0.003). Subgroup analysis indicates that subjects with baseline acuity worse than 20/40 derived the greatest benefit at one year (mean difference 3.0 lines in study eyes at 12 months, p=0.001). In primary study eye group 20% of subjects have a ≷= 2.5 line improvement in acuity, compared to only 9% in the placebo control group . Adverse events from the apheresis treatment were self-limited and typical for extracorporeal therapies. Conclusion:The apheresis procedure produced significant vision benefits at one year in pre-angiogenic AMD patients. The mechanism of action remains under investigation, but may involve hemorheologic/blood flow effects in the choriocapillaris and/or removal of specific pathologic macromolecules from the plasma. These encouraging early results should stimulate further research into the basis for this treatment effect and may lead to new treatment strategies.
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