Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Dietary Supplement: Oral treatment Alzer y Diamel; Dietary Supplement: Placebo

• 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

Arm && Interventions

Group	Intervention	Description
Group I	Oral treatment Alzer y Diamel	32 patients with mild or moderate diabetic macular edema.
Group II	Placebo	32 patients with mild or moderate diabetic macular edema

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