Long Term Improvement of Early AMD Treated With PhototropTM : Prospective Case Studies

Abstract

Purpose:: Age-related macular degeneration (AMD) is a progressive sight-threatening disease of the retina. Recently, a randomized, double-blind, placebo controlled clinical trial showed that a short term (12 months) treatment with a combination of omega 3 fatty acids, coenzyme Q10 and acetyl-L-carnitine (Phototrop^TM) initially improved andthen stabilized visual functions and fundus alterations in early AMD. The aim of this study was to demonstrate the long term effects of Phototrop^TM treatment on visual functioning, fundus alterations and on the quality of life in the early AMD population.

Methods:: 32 cases of early AMD treated with Phototrop^TM were selected from consecutive cases of outpatients as described in the previous clinical trial. The treatment period lasted from 13 months to 36 months (mean 26.5 months). Changes in visual functions were measured by visual acuity, foveal sensitivity, visual field mean defect (Central 10-2 visual field program), Amsler test. Furthermore fundus alterations (drusen covered area), fluorescein angiography and OCT images were evaluated. Changes in life quality were also recorded.

Results:: Visual functions in these cases showed an early improvement and then remained at the same levels, (visual acuity 90% of cases, visual field 83% of cases, foveal sensitivity 80% of cases, Amsler test 56% of cases). Drusen covered areas showed a slow reduction (90% of cases) and this tendency was observed even after 3 years (44% of cases). Decrease in late fluorescein staining was also observed (53% of cases). OCT showed more regular pigment epithelial layer (60% of cases). These changes were associated with significant improvement in the quality of life of patients (72% of cases), as well as a decrease of dry eye symptoms (87% of cases).

Conclusions:: These prospective case studies on the long term effects of Phototrop^TM treatment confirmed the previous clinical trial’s data on an initial improvement followed by stabilization of visual functions in early AMD. Surprisingly, fundus alterations may further improve after one year of treatment, as shown by three different objective methods. All of these findings give further support to the efficacy of the long term use of Phototrop^TM in early AMD patients, as early AMD may continue to improve even after 12 months of use.

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • nutritional factors