Diabetic Retinopathy Sulodexide Study

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajou University School of Medicine
• Treatments: Glucuronyl glucosamine glycan sulfate

Criteria

Inclusion Criteria:

• Patients with Type 1 or Type 2 Diabetes Mellitus

• Diabetes under good control with drugs for at least 6 months (Glycosylated hemoglobin <9% )

• Patients with 300um ≤ the thickness of retina by optical coherence tomography

• Patients with visual acuity test ≥0.4 (20/50)

• Non-proliferative (background) retinopathy assessed by fundus photography and fluorescein angiography according to Airlie House Classification and ETDRS

• Patients with non-proliferative (background) retinopathy attested by the presence of Hard exudates within grade 2 and 5

• Patients with at leat one of the following lesions: Vascular leakages, Microaneurysms, Haemorrhages, Intraretinal microvascular abnormalities (IRMA)

• Patients with controlled Arterial Blood Pressure since the last 6 months (Diastolic Blood Pressure ≤90mmHg and Systolic Blood Pressure ≤130 mmHg) with or without medication

• Patients capable of conforming to the study protocol

• Patients who have given their free and informed consent

• The ability and willingness to comply with all study procedures

Exclusion Criteria:

• Diabetic Retinopathy which is being treated with laser therapy or should be treated with laser therapy before the end of the study

• Concomitant retinal disease due to causes other than diabetic microangiopathy

• Concomitant antihypertensive treatment, unless administered at stable dosage at least 6 months before the start of the study

• Concomitant Angiotensin-converting enzyme inhibitor / Angiotensin II receptor blocker therapy, unless administered at stable dosage for at least 6 months prior to the start of the study

• Concomitant Warfarin therapy

• Patients with laser therapy or intravitreal injection(avastin,steroid) within 3 months from enrolment

• Concomitant treatment with hemorrheological, vasoactive drugs and antithrombotics except acetylsalicylic acid at stable dosage

• Patients with severe liver impairment (Child-Pugh classification C)

• Patients with severe renal insufficiency (creatinine >2.2 mg/dl)

• Patients with severe cardiac insufficiency (New York Heart Association classes 3 - 4)

• Patients with clinical history of diathesis and haemorrhagic disease

• Individual hypersensitivity toward the product, heparin, low molecular weight heparin or heparin-like products

• Intended or ascertained pregnancy or lactation

• Participation to a trial within the past 6 months

• Surgery or trauma within the past 6 months

• Planned surgical intervention within 6 months from enrolment

• Patients unable to conform to the study protocol