Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

Phase 2

Completed

• Conditions: Diabetic Macular Edema

• Registration Number: NCT03533478
• Lead Sponsor: Catalysis SL

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-23
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Macular retinal thickness	1 year	macular retinal measure

Secondary Outcome Measures

Name	Time	Method
Visual acuity	1 year	visual acuity test

Trial Locations

Locations (1)

National Institute of Endocrinology; 🇨🇺 Vedado, Havana, Cuba

National Institute of Endocrinology

🇨🇺Vedado, Havana, Cuba