Clinical Trials Logo
  1. Home
  2. Diabetic Retinopathy
  3. NCT04742829

Effects of a Therapy With INTRAVIT® Tablets in Patients With Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:
Evaluation of the Effect of a Therapy With INTRAVIT® Tablets on Retinal Edema, Retinal Sensitivity and Visual Acuity in the Course of Diabetic Retinopathy

Clinical Trial Summary

Evaluation of the effect of a therapy with INTRAVIT® tablets, on retinal edema considering also the central retinal sensitivity (Microperimetry) and the visual acuity in course of diabetic retinopathy.

Clinical Trial Description

Retinal edema is an abnormal accumulation of fluids in the retina, is a complication of certain eye diseases such as diabetic retinopathy, exudative macular degeneration, surgical or para - surgical practices and trauma. The main factors involved in the formation of retinal edema are due to structural alterations of blood vessels, formation of neovessels and phlogistic phenomena. INTRAVIT® is a product based on extracts of Artemisia, Turmeric, Pineapple and Black Pepper, formulated in a targeted way to support the treatment of retinal edema and treatments with intravitreal injections. Artemisia (artemisinin and its derivatives) has proven to be able to counteract the activity of VEGF, VEGFR, metal protein (MM2 and MMP9) and integrins αvβ3, all factors involved in the angiogenetic process. Turmeric (curcumin) has been shown to be able to counteract the phlogistic processes in various districts in addition to acting on the reduction of angiogenesis. The Pineapple (Bromelain) for its proteolytic activity has been able to favor the resorption of the edema and the reduction of the phlogistic phenomena. Black pepper (piperine) has proven to be able to counteract the phlogistic processes and encourage the bioavailability of some natural extracts such as curcumin. The purpose of the study is to evaluate the effect of a therapy with INTRAVIT® tablets, on retinal edema considering also the central retinal sensitivity (Microperimetry) and visual acuity in the course of diabetic retinopathy. Diabetic patients with mild non-proliferant diabetic retinopathy (at an early stage) with macular edema will be enlisted. 40 patients, of which 20 will be treated with INTRAVIT® tablets (2 tablets per day morning and evening before meals), and 20 who will not take any medical therapy to overlap with the activity described for INTRAVIT® (control group). Patients covered by the inclusion criteria will undergo, before the start of treatment, a full eye examination and OCT (optical coherence tomography) for the measurement of foveal thickness. Based on the preordered randomization scheme they will be assigned to Group 1 or Group 2 (control group). Patients will undergo a first examination at the time of recruitment (T0), and subsequent visits (T1-T2) will fall to 3 and 6 months.The data collection sheet will report all adverse effects potentially attributable to the administration of the food supplement INTRAVIT® tablets. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04742829
Study type Interventional
Source University of Molise
Contact
Status Active, not recruiting
Phase N/A
Start date October 1, 2020
Completion date March 8, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT03660384 - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy N/A
Completed NCT04905459 - ARDA Software for the Detection of mtmDR
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT05022615 - Comparing 3 Imaging Systems
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT03702374 - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04009980 - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus. N/A
Completed NCT02924311 - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting NCT06257082 - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities N/A
Not yet recruiting NCT05452993 - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography N/A
Withdrawn NCT02812030 - Aflibercept for Retinopathy in the Real World N/A
Completed NCT02391558 - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography N/A
Active, not recruiting NCT02353923 - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy N/A
Active, not recruiting NCT02330042 - OCT Biomarkers for Diabetic Retinopathy
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A