Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

Catalysis SL

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Oral treatment Alzer y Diamel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03533478

ALZER-DIAMEL-EMD-2014

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Group I

Experimental group

Description:

32 patients with mild or moderate diabetic macular edema.

Treatment:

Dietary Supplement: Oral treatment Alzer y Diamel

Group II

Placebo Comparator group

Description:

32 patients with mild or moderate diabetic macular edema

Treatment:

Dietary Supplement: Placebo