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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
2 tablets per day morning and evening before meals
University of Molise
Campobasso, Italy
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 6 months
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