Efficacy of Alzer^®and Diamel, Nutritional Supplements, in the Prevention of Severe Diabetic Macular Edema

Introduction: Macular edema is the main cause of low vision in diabetic patients. Laser photocoagulation continues to be the treatment of choice in conjunction with the use of steroids and anti-angiogenics, but these treatments include possible ocular complications. The nutritional supplement Alzer (whose primary active ingredient is Ginkgo biloba, a powerful antioxidant that acts on vascular factors and oxidative damage, which are two of the mechanisms implicated in the pathogenesis of diabetic macular edema), which has been used on other non-diabetic macular conditions, along with the Diamel nutritional supplement has been shown to be effective on glycemic control and could represent a treatment alternative for mild to moderate macular edema by reducing the thickness of the macular retina and preventing the progression of other more advanced clinical presentations that are harder to treat. Objective: Identify the effect of Alzer along with Diamel in reduction of the thickness of the macular retina among patients with mild to moderate diabetic macular edema. Materials and Methods: A phase II double-blind clinical trial was conducted in 64 patients with non-severe diabetic macular edema over the course of non-proliferative diabetic retinopathy, who attended the ophthalmology service of the Institute of Endocrinology of Havana from January 2016 to December 2016. The treatment was randomly assigned to two groups: one received Alzer plus Diamel (n = 32) and the other group received Alzer placebo + Diamel placebo (n = 32). All patients were given an initial clinical evaluation, blood testing and ophthalmological evaluation at the start of treatment and after one year of follow-up. Results: There was a clinical improvement in the macular thickness upon the conclusion of the study in the patients treated with Alzer and Diamel. This decrease in thickness was statistically significant in the left eye. There was no decrease in visual acuity one year after treatment. Adverse events were mild and uncommon. Conclusions: Severe macular edema did not evolve in the Alzer and Diamel group. The clinical, but not statistically significant, success obtained in the experimental group proves the protocol hypothesis regarding the efficacy of the product being researched. The positive results in this small sample lead to the suggestion of performing larger-scale studies (Phase III). The clinical trial was registered in Clinical Trials.gov Identifier: NCT03533478.