NCT03533478

Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral 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_SUPPLEMENT	Placebo	Placebo treatment

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-12-01
• Completion: 2018-12-30
• First posted: 2018-05-23
• Last updated: 2019-05-22

Locations

1 site across 1 country: Cuba