drugset / Trial / NCT04071977

Combined Antioxidant Therapy on Oxidative Stress in Aqueous and Vitreous Humor of Diabetic Retinopathy Patients

NCT04071977

RandomizedParallel-groupDouble-blindTreatment

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 56 patients with proliferative diabetic retinopathy undergoing the vitrectomy procedure, who will be assigned to a placebo group or combination antioxidant therapy. Each group will receive the intervention for 2 months. This intervention consists of taking one tablet (placebo or antioxidant therapy) orally, once a day. At the beginning of the study, only blood samples will be collected to evaluate the state of oxidative and metabolic stress at a systemic level. After 2 months of intervention, blood samples will be taken again on the day of the intervention, adding the samples of aqueous and vitreous humor obtained during the vitrectomy. The results obtained between both groups and the different analysis matrices will be compared.

Timeline

Start
2020-03-25
Primary completion
2021-10-31
Completion
2021-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Astaxanthin Small molecule 4 mg Oral
Comparator Copper Unknown 1 mg Oral
Comparator Lutein Other / unclassified 10 mg Oral
Comparator Vitamin C Other / unclassified 180 mg Oral
Comparator Vitamin E Other / unclassified 30 mg Oral
Comparator Zeaxanthin Small molecule 1 mg Oral
Comparator Zinc Oxide Unknown 20 mg Oral