Diabetic Retinopathy Sulodexide Study

NCT01295775 | Completed Phase 2 DMC

• 1 other identifier: DRESS_Korea
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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

Diabetic Retinopathy

Keywords

diabetic retinopathy; sulodexide; hard exudates; microaneurysms; hemorrhages; intraretinal microvascular abnormalities

Outcome Measures

Primary Outcomes (1)

• Hard exudates

  The lesion will be evaluated by fundus photography and fluorescein angiography, graded according to Modefied Airlie House Classification and ETDRS.

  T12: 360 +/- 7 days from T0

Secondary Outcomes (4)

• microaneurysms

  T12: 360 +/- 7 days from T0

• Vascular leakage

  T12: 360 +/- 7 days from T0

• Haemorrhages

  T12: 360 +/- 7 days from T0

• Intraretinal microvascular abnormalities (IRMA)

  T12: 360 +/- 7 days from T0

Study Arms (2)

Sulodexide group

ACTIVE COMPARATOR

50 mg of sulodexide a day will be administered by oral route (1+1 capsule/day) for 360 days

Drug: sulodexide

Placebo group

PLACEBO COMPARATOR

Sulodexide placebo will be administered at the same schedule (1+1 capsule/day) and for the same lengths of time (for 360 days) as Sulodexide group

Drug: sulodexide

Interventions

sulodexide DRUG

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.

Also known as: vessel due F

Placebo group; Sulodexide group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Kangnam Sacred Heart Hospital, Colloge of Medicine, Hallym University

Seoul, 150-071, South Korea

Location

Related Publications (1)

• Song JH, Chin HS, Kwon OW, Lim SJ, Kim HK; DRESS Research Group. Effect of sulodexide in patients with non-proliferative diabetic retinopathy: diabetic retinopathy sulodexide study (DRESS). Graefes Arch Clin Exp Ophthalmol. 2015 Jun;253(6):829-37. doi: 10.1007/s00417-014-2746-8. Epub 2014 Aug 12.

  PMID: 25112845 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Microaneurysm; Hemorrhage

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Aneurysm; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ha Kyoung Kim, MD

  Department of Ophthalmology, Kangnam Sacred Heart Hospital, College of Medicine, Hallym University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: February 15, 2011
• Study Start: February 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

KR (1)