The efficacy and safety of adjuvant supplementation with green tea extract on diabetic macular edema, a double blind randomized clinical trial

Evaluation of the effect of GTE supplementation on patients with DME treated with anti-vascular endothelial growth factor (VEGF) or corticosteroids.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients.

Postchy clinic, the daily supplement of green tea extract and placebo is randomly given to patients, researchers, patients and clinical caregivers are the ones who are blinded.

Conditions of entry: type 2 diabetes; age between 30 and 65 years old; patients diagnosed with Diabetic Macular Edema (DME); receive standard treatment; central macular thickness (CMT) greater than 350 μm; willing and capable of providing written informed consent. Exit conditions: monocular; Glaucoma; epiretinal or vitreomacular membrane tension in fundus examination or OCT; significant cataract; vitreous hemorrhage; previous vitrectomy; previous history of cataract surgery; high myopia; systemic or intravitreal injection of immunosuppressive drugs and corticosteroids; liver or kidney failure; pregnant or lactating women; known sensitivity to green tea extract (GTE) or any of the excipients in GTE tablets; currently taking any medication or herbal supplement that may interfere with the study intervention; inability or unwillingness to comply with study procedures and follow-up program.

Participants were randomly assigned to receive a daily green tea extract (GTE) supplement or a placebo pill for 24 weeks.

Improving visual acuity and reducing the thickness of the macula

Randomization is first by creating a random sequence in simple randomization dividing people into control and intervention groups from the table of random numbers.

Both participants and researchers, including those responsible for administering the intervention and assessing outcomes, will be blinded to the treatment allocations. Identical-appearing capsules containing either the green tea extract or a placebo will be used to prevent differentiation. Allocation concealment will be achieved through the use of a computerized randomization process managed by an independent third party, ensuring that neither the participants nor the investigators can predict the group assignments. Additionally, outcome assessors and data analysts will remain blinded to the treatment groups to maintain the integrity of the study results. Regular monitoring and verification procedures will be employed to ensure adherence to blinding protocols throughout the trial.