Diabetic Macular Edema
Conditions
Interventions
Diamel Group (Experimental): The Diamel will be administered one vial (30 ml) ® oral solution once a day, in the morning, for 12 months.
Placebo Group (Experimental): The placebo will be administered
Sponsors
Catalysis Laboratories, SL.
Eligibility
Sex/Gender
All
Age
20 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Type 1 or 2 diabetic patients with diabetic macular edema that does not affect the center of the macula, treated or not with laser. 2. Patients between the ages of 20 and 69 years. 3. Patients with glycosylated hemoglobin (HbA1c) < 9.0% at baseline. 4. Patients who voluntarily give their written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant and/or breastfeeding patients. 2. Patients with diabetic macular edema affecting the center of the macula. 3. Patients with diabetic macular edema with vitreoretinal traction. 4. Patients with refractive media opacity that makes ophthalmologic examination difficult (example: patients with cataracts or less than one year after surgery). 5. Patients with a known history of hypersensitivity to another similar product or to one of the components of the test product formulation. 6. Patients undergoing treatment with any other nutritional supplement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular thickness (It is measured in microns. It will be evaluated taking into account the response categories Satisfactory (50% decrease with respect to the baseline value), Unsatisfactory (Decrease less than 50% with respect to the baseline value or no decrease or increase in thickness macular)). Measurement time: At baseline and, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual acuity (It is measured in decimal units. The increase with respect to the baseline value will be evaluated. It will be considered satisfactory (Improvement of 0.2 tenths or more with respect to the baseline value) or unsatisfactory (Improvement of less than 0.2 tenths with respect to the baseline value, no improvement or worsening of visual acuity)). Measurement time: At baseline, at 6 months and 12 months 2. Glycemic control (It will be evaluated through the values that show the glycated hemoglobin (HbA1c) taking into account the following scale: good (if the values are less than 7.0%), acceptable (if the values are from 7.0 to 7.9%), or poor (if the values are equal to or greater than 8.0%)). Measurement time: At baseline, 3 months, 6 months, 9 months and 12 months 3. Metabolic control (Values of glycated hemoglobin, glycemia, cholesterol, triglycerides, creatinine and uric acid according to the units in which it is measured). Measurement time: At baseline, 3 months, 6 months, and 12 months. | — |
Countries
Cuba
Contacts
Public ContactArilia Garcia Lopez
National Coordinating Center for Clinical Trials
Outcome results
None listed