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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Dietary supplement: Oral treatment Alzer y Diamel; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Cuba
  • Havana
    • Vedado, Havana, Cuba, 10400
      • National Institute of Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; 32 patients with mild or moderate diabetic macular edema.	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 Comparator: Group II; 32 patients with mild or moderate diabetic macular edema	Dietary supplement: Placebo; Placebo treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular retinal thickness	macular retinal measure	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	visual acuity test	1 year

Collaborators and Investigators

• Sponsor: Catalysis SL
• Investigators: Principal Investigator: Juana Elvira Maciques Rodríguez, Dr., National Institute of Endocrinology, Cuba

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; Oxidative Stress; Diabetic Macular Edema; Nutritional supplement; Diamel; Alzer
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: ALZER-DIAMEL-EMD-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No