Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis.
OBJECTIVE
To evaluate the safety and efficacy of Rheopheresis blood filtration to treat intermediate- to late-stage preangiogenic age-related macular degeneration (AMD) with soft drusen.


METHODS
Multicenter, prospective, randomized, double-masked, placebo-controlled clinical trial.


METHODS
First 43 randomized patients (28 Rheopheresis and 15 placebo-control patients) with available baseline and 3-month postbaseline best corrected visual acuity (BCVA) measurements and intermediate- to late-stage preangiogenic AMD with multiple large soft drusen and elevated serum levels of targeted macromolecules.


METHODS
Patients were randomly assigned to receive eight Rheopheresis or eight placebo procedures over 10 weeks.


METHODS
ETDRS BCVA measurements at baseline, 3, 6, 9, and 12 months postbaseline.


RESULTS
In primary eyes, the mean LogMAR line difference between Rheopheresis and placebo-control eyes was 1.6 lines at 12 months postbaseline; the difference was significant throughout the first posttreatment year (P = .0011, repeated measures analysis). Thirteen percent of Rheopheresis compared with 0% of placebo-control eyes had a > or = 3-line improvement in BCVA at 12 months postbaseline. Four percent of Rheopheresis compared with 18% of placebo-control eyes had a > or = 3-line loss in BCVA. The subgroup of patients whose primary eyes had baseline BCVA worse than 20/40 demonstrated a mean LogMAR difference between Rheopheresis and placebo-control eyes equaling 3.0 lines at 12 months postbaseline; the difference was significant throughout the first posttreatment year (P = .0014, repeated measures analysis). Sixteen percent of Rheopheresis compared with 0% of the placebo-control eyes had a > or = 3-line improvement in BCVA at 12 months postbaseline. Five percent of Rheopheresis compared with 29% of placebo-control eyes had a > or = 3-line loss in BCVA. Fifty-eight percent of Rheopheresis eyes improved to 20/40 or better, compared with 14% of placebo-control eyes. No serious treatment-related adverse events were observed.


CONCLUSIONS
Rheopheresis demonstrated statistically significant and clinically relevant effects on BCVA when compared with placebo controls for the 12-month study interval. Untreated patients with BCVA worse than 20/40 with intermediate- to late-stage preangiogenic AMD, soft drusen, and elevated blood factors were at risk for substantial visual loss. A sample size larger than 43 patients is important to provide a basis for widespread adoption of novel therapeutic options for AMD such as Rheopheresis. Therefore, enrollment to 150 patients is continuing.
Pulido
Jose S
JS
Department of Ophthalmology and Visual Sciences, UIC Eye Center, University of Illinois at Chicago, USA.
D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006440:Hemofiltration; D006801:Humans; D008268:Macular Degeneration / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010956:Plasmapheresis / Q000379:methods*; D011446:Prospective Studies; D015593:Retinal Drusen / Q000628:therapy; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity