Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Nutritional Supplements Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema. Clinical Trial Phase II.

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Dietary Supplement: Oral treatment Alzer y Diamel
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>32 patients with mild or moderate diabetic macular edema. | Dietary Supplement: Oral treatment Alzer y Diamel<br>* 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.<br>|
| Placebo Comparator: Group II<br>32 patients with mild or moderate diabetic macular edema | Dietary Supplement: Placebo<br>* Placebo treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular retinal thickness | macular retinal measure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | visual acuity test | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional supplement, Diabetic Macular Edema, Diabetes, Alzer, Oxidative Stress, Diamel