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Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

NCT03533478 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-05-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Juana Elvira Maciques Rodríguez, Dr. · National Institute of Endocrinology, Cuba

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2018-12-01
Completion
2018-12-30

Countries

  • Cuba

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533478 on ClinicalTrials.gov