Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT02062034
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 2 diabetes mellitus
* Patients with non proliferative diabetic retinopathy
* Glycated hemoglobin \< 12.0%
* Signing of informed consent
Exclusion Criteria:
* Patients with clinically significant macular edema
* Patients with diabetic retinopathy advanced lesions that have required or require specific treatment (laser, vitrectomy)
* Pretreatment with argon laser or excimer laser Ophthalmology surgery
* Any other associated ocular pathology (glaucoma, cataracts, changing cornea dystrophy, macular degeneration)
* Pregnancy, lactation, inadequate use of contraception
* Antioxidant drug and/or supplements six months previous to enrollment
* Renal and/or hepatic failure
* Age under 30 or over 75 years
* Severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vasculopathy)
* Blood dyscrasias
* Have or have had cancer or other serious illness
* Neurodegenerative process
* Allergy to vitamins
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT02062034
Study Brief:
Protocol Section:
NCT02062034