Exploring the benefits of grape pomace supplements for diabetic eye health: new clinical trial results
- Conditions
- Improvement of ophthalmic outcomes in patients with diabetic retinopathyEye Diseases
- Registration Number
- ISRCTN15020073
- Lead Sponsor
- Inventia Biotech-Healthcare Food Research Center s.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 99
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Central Retinal Thickness (CRT) measured using optical coherence tomography (OCT), at baseline (T0) and six-months (T6)<br>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 Outcome Measures
Name Time Method