The aim of this phase 2 controlled placebo study is to assess the effectiveness of Sulodexide
in the treatment of non proliferative (background) retinopathy in patients with Type 1 and
Type 2 Diabetes Mellitus.
This is a multicentre, double-blind, randomised study involving patients affected by non
proliferative (background) diabetic mild to moderate retinopathy.
This study will involve 130 patients (65 for each group). At baseline visit (T0), the
Investigator will grade the ocular lesions due to diabetic retinopathy according to color
fundus photographs and the fluorescein angiography examination. He will subsequently send the
negatives of photographs and the images -or negatives when available- of fluorescein
angiography to an off-site Assessor -unaware of the Investigator assessment- nominated to
confirm the quality of the images and the grade of the lesions. After positive assessment of
the Investigator, at T0 the eligible patient will be blindly allocated to one of the 2
treatment groups according to a computer-generated randomisation list provided by the
Sponsor.
The following treatments will be administered for 360 days:
A (SULODEXIDE GROUP): 50 mg a day by oral route;
B (PLACEBO GROUP): Sulodexide placebo at the same schedule and for the same lengths of time
as group A.
Before breaking the randomisation code at the end of the study, an independent off site
assessor will evaluate the photographs according to the Airlie House Classification and
following modification by Early treatment Diabetic Retinopathy Study (ETDRS) and fluorescein
angiography according to ETDRS.