Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533478
• Other study ID #: ALZER-DIAMEL-EMD-2014
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2015
• Est. completion date: December 30, 2018

Study information

• Verified date: May 2018
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.
• Placebo
Placebo treatment

Locations

Country	Name	City	State
Cuba	National Institute of Endocrinology	Vedado	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular retinal thickness	macular retinal measure	1 year
Secondary	Visual acuity	visual acuity test	1 year