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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Dietary Supplement: INTRAVIT ®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes type I and type II patients; Between 20 and 70 years of age; Age of diabetes not less than 5 years and not more than 15; Mild non-proliferating diabetic retinopathy, limited to the presence of some microaneurysms; Patients in diabetic compensation; Visual acuity 5/10 natural or correct; Patients even if hypertensive, with or without anti-hypertensive therapy in place, provided they are compensated; Patients with good visualization of the ocular fundus. Exclusion Criteria: Patients with concurrent eye diseases outside diabetic retinopathy; Patients with less than natural or correct 5/10 visual acuity; Patients treated with other vasoprotective and antioxidant preparations or having taken them in the last month; Patients with significant systemic or metabolic diseases, except diabetes; Patients with unbalanced Diabetes disorder; Patients undergoing laser treatment or eye surgery (e.g. cataract); Patients who take or should take, during the observation period, preparations for direct or indirect activity on the retina of the type that can be superimposed on INTRAVIT ®.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Observational study, open, controlled between homogeneous groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP 1<br>Patients treated with INTRAVIT® tablets | Dietary Supplement: INTRAVIT ®<br>* 2 tablets per day morning and evening before meals<br>|
| No Intervention: GROUP 2<br>patients who will not take any medical therapy to overlap with the activity described for INTRAVIT® tablets. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with signs of improvement/worsening of diabetic retinopathy | report presence/absence of signs with Yes/NO relative to: microaneurysms, haemorrhages, soft exudates, hard exudates, venous beading, IRMA, new vessels on optical discs, new vessels outside the optical discs, cystoid edema, capillary occlusions, degenerative alterations and vein size. | 6 months | 
| number of participants in a certain stage of diabetic retinopathy according to the ETDRS modified AAO 2003 | careful evaluation of funduscopic signs (e.g exudates, neovases, micronaneurysms) to be able to stadiate patients | 6 months | 
| number of patients with improved/worsened visual acuity | visual acuity measurement with ETDRS boards. The number of letters seen by the patient at each check-up visit will be noted. | 6 months | 
| number of patients with improved/worsened macular edema | Foveal thickness (measured with Optical Coherence Tomography) at each check-up visit will be noted. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with improved/worsened blood parameters related to diabetes | blood sugar (mg/dl) using a rapid glucose test at each check-up visit will be noted and glycated hemoglobin (%) will be assesed with venous blood sampling at the beginning of the study and at 3 and 6 months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy, macula edema, microperimetry, curcumin, artemisin, piperine, bromelain