Improvement of ophthalmic outcomes in patients with diabetic retinopathy Eye Diseases
Conditions
Interventions
The intervention in this study consists of administering a nutraceutical formulation based on maltodextrinated grape pomace extract (MaGPE) to patients with diabetic retinopathy (DR). The MaGPE supple
Sponsors
Inventia Biotech-Healthcare Food Research Center s.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Central Retinal Thickness (CRT) measured using optical coherence tomography (OCT), at baseline (T0) and six-months (T6) 2. Best-Corrected Visual Acuity (BCVA) assessed using the 4 m logarithmic visual acuity chart with an Early Treatment Diabetic Retinopathy System (ETDRS) chart, at baseline (T0) and six-months (T6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline (T0) and after six months of treatment (T6): 1. Glucometabolic Parameters: 1.1. Fasting Plasma Glucose (FPG) measured using commercially available kits (Diacron International, Italy). Blood samples are collected from participants after an overnight fast 1.2. Fasting Plasma Insulin (FPI): FPI levels are determined using an enzyme-linked immunosorbent assay (ELISA) 1.3. The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is calculated using the formula: FPG (mg/dL) × FPI (µU/mL) / 405. 1.4. Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) are measured using commercial enzymatic kits 2. Oxidative Stress Markers: 2.1. Reactive Oxygen Metabolites (d-ROMs): The levels of d-ROMs are measured using an automated analyzer (Free Carpe Diem, Diacron International, Grosseto, Italy) with commercially available kits (Diacron International) 2.2. Oxidized Low-Density Lipoprotein (oxLDL): oxLDL levels are assessed using an automated analyzer (Free Carpe Diem, Diacron International, Grosseto, Italy) with commercially available kits (Diacron International) | — |
Countries
Italy
Contacts
Public ContactVincenzo Scorcia
Outcome results
None listed