Status:
COMPLETED
Combined Antioxidant Therapy on Oxidative Stress in Aqueous and Vitreous Humor of Diabetic Retinopathy Patients
Lead Sponsor:
University of Guadalajara
Collaborating Sponsors:
Hospital Civil de Guadalajara
Conditions:
Diabetic Retinopathy
Oxidative Stress
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The present study aims to support previous research on the effects of antioxidant therapy on the outcome of diabetic retinopathy and local oxidative stress values. The researchers intend to evaluate 5...
Detailed Description
Diabetic retinopathy is a diabetes microvascular complication due to an insufficient oxygen supply to its endothelial cells in states of constant hyperglycemia. This entity is classified in two main c...
Eligibility Criteria
Inclusion
- Patients with type 2 with proliferative diabetic retinopathy
- Blood pressure under 160/100 mmHg
- HbA1c equal or lower than 9%
- LDL under 190mg/dl, triglycerides under 500mg/dl)
- Signed informed consent
- Patients scheduled for vitrectomy surgery, under the following indications:
- Severe vitreous hemorrhage lasting 1-3 months or longer, which does not go away spontaneously
- Rhegmatogenous or tensile retina detachment
- Epiretinal membrane that involves macula and that includes vitreomacular traction
Exclusion
- Vitreous hemorrhage for any cause other than Proliferative Diabetic Retinopathy complication
- Patients with vitrectomy surgery in the last 6 months
- Patients with laser surgery in the last 6 months
- Intravitreal application of antiangiogenic agents in the last 2 months
- Patients with other ocular pathologies such as age-related macular degeneration, glaucoma, endophthalmitis, conjunctivitis of any etiology, severe lacrimal film dysfunction syndrome, etc.
- Patients with concomitant systemic diseases such as: rheumatoid arthritis, sjogren's syndrome, upper respiratory tract infections, gastrointestinal infections, sepsis, any infectious process
- Patients with severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vascular disease)
- Oral antioxidant intake that exceeds the daily recommendations in the last 6 months.
- Consumption of pharmacological agents such as: immunomodulators, biological, anti-inflammatory, in the last 3 months
- Smokers
- Patients with neurodegenerative or carcinogen processes
- Patients who are currently participating in other clinical trials
Key Trial Info
Start Date :
March 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04071977
Start Date
March 25 2020
End Date
December 31 2021
Last Update
April 1 2022
Active Locations (1)
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1
Institute of Experimental and Clinical Therapeutics,
Guadalajara, Jalisco, Mexico, 44340