Efficacy of a nutraceutical formulation based on maltodextrinated grape pomace extract in patients with diabetic retinopathy: a randomized, single-blind, placebo-controlled trial

Inventia Biotech-Healthcare Food Research Center s.r.l.0 个研究点目标入组 99 人开始时间: 2024年7月8日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•1. Confirmed diagnosis of mild and moderate non-proliferative diabetic retinopathy (DR) based on the International Clinical Diabetic Retinopathy (ICDR) and Diabetic Macular Edema Severity Scale
•2. Ocular treatment with intravitreal anti-VEGF injections
•3. Age over 18 years
•4. Focal edema identified by OCT scan measuring less than 400 µm

•1. Presence of other retinal diseases linked with macular edema
•2. Active or suspected ocular or periocular infection, active epithelial keratitis (dendritic keratitis), mycobacterial and fungal infections, advanced glaucoma, aphakic eye with rupture of the posterior capsule, eyes with anterior chamber intraocular lenses, scleral-fixated and iris-fixated intraocular lens and with rupture of the posterior capsule, recent ocular surgery (within the last 3 months), and ischemic maculopathy
•3. Severe hepatic, renal, and cardiovascular diseases, other chronic degenerative diseases such as cancer, pregnancy, suspicion of pregnancy, breastfeeding, birch pollen allergy, and the use of medications or supplements containing grape polyphenols.

发起方

Inventia Biotech-Healthcare Food Research Center s.r.l.