First Author: T.Hergeldzhieva Fileva SWITZERLAND
Co Author(s): A. Scarpatetti
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To present our experience with Ocufolin™ as a supplement therapy in patients with age-related macular degeneration (AMD).
Eye Clinic Dr. A. v. Scarpatetti, Teufen, Switzerland
We retrospectively reviewed the clinical records of all consecutive patients with Ocufolin™ supplement therapy between August 2015 and September 2016. A thorough ocular, medical and family history were obtained in all cases. The clinical evaluation included best-corrected visual acuity (BCVA), biomicroscopy, measurement of intraocular pressure, and dilated ophthalmoscopy. colour fundus photography and Spectral Domain optical coherence tomography were useful to document the disease and to monitor its progression. Genetic testing for the methylenetetrahydrofolate reductase (MTHFR) C677T and A1298T gene mutations were also performed in majority of patients. Ocufolin™ contains the active metabolite of folic acid (L-methylfolate) and other vitamins, which reduce homocysteine levels and protect retinal, choroidal, and macular tissues from oxidative stress caused by high levels of homocysteine as well as minerals and carotenoids known from the ARED-studies. Ocufolin™ was given in a dosage of 1 capsule orally per day to all patients. Surgical procedures (intravitreal injections, cataract surgery etc.) were also done depending on indications. The follow up examinations were performed at the first and third month, and in three months intervals thereafter.
Between August 2015 and September 2016 Ocufolin™ supplement therapy was prescribed to 42 patients. AMD was the reason for therapy in 35 patients (83%). Eighteen female (51.4%) and 17 male (48.6%) patients with an average age of 79.2 years (range 58-98) were included in this retrospective study. Twenty three patients (65.7%) had dry AMD, 6 patients (17.2%) had neovascular AMD, and 6 patients (17.2%) had both forms of AMD. The mean BCVA at the baseline and the last follow up visit was 0.81 LogMAR (interval 0.0 - +1.5) and 0.76 LogMAR (interval 0.0 - +1.5) respectively. Genetic testing was performed in 26 patients (74.3%) with AMD and in 20 cases (57%) mutations were diagnosed suggesting reduction of the function of MTHFR enzyme and higher homocysteine blood levels respectively. Twelve patients (34.3%) needed surgical interventions- intravitreal injections (9 patients, 25.7%), FALCS (2 patients, 5.7%), and PPV with silicone oil tamponade (1 patient, 2.9%). None of the patients reported ocular or systemic serious adverse events. The average period of observation was 9 months (interval 3-19 months). Reasons for discontinuation of supplement therapy were mainly financial issues since the Ocufolin™ is not reimbursed by the health insuarence.
Despite retrospective design, relatively short follow up period and limited number of patients in our study our observations show that Ocufolin™ is well tolerated as a supplement therapy in individuals with AMD. Futher studies are needed to confirm its effect in preservation and stabilization of vision during the course of AMD.