Status:
UNKNOWN
Effects of a Therapy With INTRAVIT® Tablets in Patients With Diabetic Retinopathy
Lead Sponsor:
University of Molise
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief 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...
Detailed 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 p...
Eligibility Criteria
Inclusion
- 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
- 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 ®.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04742829
Start Date
October 1 2020
End Date
March 8 2021
Last Update
February 8 2021
Active Locations (1)
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1
University of Molise
Campobasso, Italy