Diabetic Macular Edema
Conditions
Keywords
Nutritional supplement, Diabetic Macular Edema, Diabetes, Alzer, Oxidative Stress, Diamel
Brief summary
Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel combination in mild and moderate macular edema. Material and method: A randomized double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive Alzer + Diamel and another will receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and ophthalmological evaluation during the study.
Interventions
DIETARY_SUPPLEMENTOral treatment Alzer y Diamel
Alzer: Administration way: Oral Dosage: one 500 mg tablet 3 times a day (1500 mg daily) Frequency: after breakfast, lunch and dinner. Duration: one year. Diamel: Administration way: Oral Dosage: two 660mg capsules 3 times a day (3960 mg daily) Frequency: before breakfast, lunch and dinner. Duration: one year.
DIETARY_SUPPLEMENTPlacebo
Placebo treatment
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diabetics type 2 insulin treated. * Age between 18 and 65 years. * Glycosylated hemoglobin (HB A1c) \<8% at the beginning of the investigation. * Patients who express written voluntariness to enter the study with their signature of the informed consent document. * If woman of childbearing age, negative pregnancy test and use of barrier contraceptives.
Exclusion criteria
* Pregnancy and lactation. * Age over 65 years. * Macular edema with vitreous-retinal traction or other cause (renal, arterial hypertension, post-surgical). * Opacity of the refractive media that hinders the ophthalmological examination. * History of hypersensitivity to another similar product or one of its components. * Patients at potential risk of not compliance the study (those who will travel during the period of the investigation or distance in their residence, outside the city). * Subjects who are participating in another clinical trial Patients with cognitive disorders or a mental disorder that hinders their follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular retinal thickness | 1 year | macular retinal measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 1 year | visual acuity test |
Countries
Cuba
Outcome results
None listed