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OpenTrials
Completed

NCT Number: NCT03533478

Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

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.

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Key information

Conditions

Diabetic Macular Edema Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Endocrinology

Vedado, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral treatment Alzer y Diamel

Dietary Supplement

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

Dietary Supplement

Placebo treatment

Primary outcomes

  1. Macular retinal thickness

    Time frame: 1 year

    macular retinal measure

Secondary outcomes

  1. Visual acuity

    Time frame: 1 year

    visual acuity test

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 23, 2018
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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