Back to resultsAlzer® and Diamel® to Prevent Severe Diabetes Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Oral treatment Alzer y Diamel
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Macular Edema focused on measuring Nutritional supplement, Diabetic Macular Edema, Diabetes, Alzer, Oxidative Stress, Diamel
Eligibility Criteria
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.
Sites / Locations
- National Institute of Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group I
Group II
Arm Description
32 patients with mild or moderate diabetic macular edema.
32 patients with mild or moderate diabetic macular edema
Outcomes
Primary Outcome Measures
Macular retinal thickness
macular retinal measure
Secondary Outcome Measures
Visual acuity
visual acuity test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03533478
Brief Title
Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema
Official Title
Efficacy of Nutritional Supplements Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema. Clinical Trial Phase II.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Nutritional supplement, Diabetic Macular Edema, Diabetes, Alzer, Oxidative Stress, Diamel
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
32 patients with mild or moderate diabetic macular edema.
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
32 patients with mild or moderate diabetic macular edema
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral treatment Alzer y Diamel
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
Macular retinal thickness
Description
macular retinal measure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visual acuity
Description
visual acuity test
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juana Elvira Maciques Rodríguez, Dr.
Organizational Affiliation
National Institute of Endocrinology, Cuba
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Endocrinology
City
Vedado
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema
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