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Diabetic Retinopathy Sulodexide Study

NCT01295775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2012-11-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

sulodexide

A (SULODEXIDE GROUP): 50 mg a day by oral route (1+1 capsules/day) for 360 days B (PLACEBO GROUP): Sulodexide placebo at the same schedule dosage and for the same lengths of time as group A.

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Ha Kyoung Kim, MD · Department of Ophthalmology, Kangnam Sacred Heart Hospital, College of Medicine, Hallym University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01295775 on ClinicalTrials.gov