First Author: F.Ali CANADA
Co Author(s): N. Armogan
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To investigate the efficacy and safety of HELP apheresis as a viable therapy for dry AMD. There are currently no approved therapies for dry AMD that have demonstrated improvements in visual acuity or retinal morphology. A pilot study of HELP for dry AMD demonstrated positive clinical results. HELP apheresis is CE and FDA approved for the treatment of familial hypercholesterolemia. HELP has demonstrated positive effects on inflammatory-related medical conditions including: ischaemic optic neuropathy, unilateral sudden hearing loss, and coronary artery disease. Given the relationship between in vivo inflammatory processes and AMD pathogenesis, HELP is a potential therapy for dry AMD.
All patients were recruited from, and all study-related treatments and assessments were performed at, the Canadian Centre for Advanced Eye Therapeutics in Mississauga, Ontario, Canada.
A prospective, non-randomized, open-label study including 37 eyes of 21 patients. Study protocol was IRB approved. HELP apheresis was performed using the Futura apheresis system developed by B. Braun Avitum AG, Germany. During the process, the patient is connected to the apheresis system via two small gauge venous cannulas. Plasma is separated from whole blood and passed through the heparin precipitation system. The precipitation system removes specific lipoprotein, complement, and inflammatory components from plasma. The plasma is recombined with whole blood and returned to the patient. No net loss of blood volume results, and no foreign blood products are used. Patients received 8 HELP apheresis treatment sessions over a period of 8-12 weeks in an outpatient retina clinic. Each session lasted between 1 and 2 hours. ETDRS visual acuity, colour fundus photography, fundus auto-fluorescence photography, and SD-OCT imaging were performed at baseline and at 6 and 12 months post-baseline. Imaging data was analyzed by the Fundus Photography Reading Centre, Wisconsin, USA, using quantitative image analysis software. All eyes had dry AMD with at least one soft drusen. Exclusion criteria included: wet AMD in either eye, and previous retinal laser, surgery, or intra-vitreal injection, or other retinal disease in study eye.
37 eyes were included in the study. Mean BCVA improved by 3.4 letters from baseline to month 6. Mean BCVA improved by 2.6 letters from baseline to month 12. Comparing baseline to month 6: BCVA improved in 78% of eyes, 43% gained 5 or more letters, 3% gained 15 or more letters, 14% had a loss in BCVA, 5% lost 5 or more letters, 0% lost 15 or more letters. Comparing baseline to month 12: BCVA improved in 68% of eyes, 38% gained 5 or more letters, 3% gained 15 or more letters, 24% had a loss in BCVA, 5% lost 5 or more letters, 0% lost 15 or more letters. Comparing baseline to month 12: Drusen volume decreased in 21% of eyes (range: -0.02 mm3 to -0.72 mm3). Total retinal volume decreased in 71% of eyes (range: -0.02 mm3 to -0.43 mm3). Mean central subfield retinal thickness decreased by 7.3µ with 84% of eyes demonstrating a reduction. Areas of abnormal auto-fluorescence decreased in 43% of eyes, and was unchanged in 18% of eyes. No serious adverse events, and no ocular adverse events related to the study procedures or therapy occurred.
HELP apheresis resulted in visual acuity improvement in dry AMD patients. SD-OCT and fundus auto-fluorescence photography also demonstrated positive, objective changes in retinal imaging parameters after HELP apheresis. The therapy demonstrated a very high safety profile. HELP therapy utilizes a CE and FDA approved device which likely alters the inflammatory pathogenesis of dry AMD, resulting in vision improvement and favourable changes in retinal morphology and function. HELP apheresis offers a safe and effective therapy for dry AMD.