NCT03533478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2018

Enrollment Period

3.8 years

First QC Date

May 11, 2018

Last Update Submit

May 21, 2019

Conditions

Diabetic Macular Edema

Keywords

Nutritional supplementDiabetic Macular EdemaDiabetesAlzerOxidative StressDiamel

Outcome Measures

Primary Outcomes (1)

  • Macular retinal thickness

    macular retinal measure

    1 year

Secondary Outcomes (1)

  • Visual acuity

    1 year

Study Arms (2)

Group I

EXPERIMENTAL

32 patients with mild or moderate diabetic macular edema.

Dietary Supplement: Oral treatment Alzer y Diamel

Group II

PLACEBO COMPARATOR

32 patients with mild or moderate diabetic macular edema

Dietary Supplement: Placebo

Interventions

Oral treatment Alzer y DiamelDIETARY_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.

Group I
PlaceboDIETARY_SUPPLEMENT

Placebo treatment

Group II

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Endocrinology

Vedado, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Juana Elvira Maciques Rodríguez, Dr.

    National Institute of Endocrinology, Cuba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

March 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 30, 2018

Last Updated

May 22, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CU(1)