Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2009-02-28
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Diabetic retinopathy is mainly a vascular disease, primarily affecting the capillaries. The first ultrastructural and microscopic changes reported are retinal capillary basement membrane thickening and pericyte degeneration, both of which compromise the integrity of the capillary wall, followed by pericyte loss.
The glycosaminoglycans (GAGs) of the basal membrane are progressively substituted by collagen, leading to a modification in vascular permeability due to the altered anionic charge. These changes lead to the clinical appearance of vascular leakage from retinal capillaries followed by microaneurysms. The lack of integrity of the vessel wall leads to haemorrhages, and to microthrombosis, which are responsible for the first ischemic lesions. If the vascular leakage lasts for a long time, the lipidic fraction of leaked plasma deposits in the retina forming hard exudates.
The substitution of GAGs by collagen leads to a basal membrane thickening also in the kidney. As in the retina, the modification of permeability occurs in the renal glomeruli and induces the selective loss of proteins (albuminuria).
Recent papers show a specific modification in GAGs metabolism occurring in diabetic patients that could be the common pathogenetic mechanism of vascular diabetic failure. Therefore, diabetic retinopathy and diabetic nephropathy may be regarded as the result of the alteration of a common underlying molecular mechanism whose expression is the depletion of GAGs from the basement membrane in both retinal and glomerular capillaries. In agreement with the previous statement, the Wisconsin Epidemiologic Study of Diabetic Retinopathy concluded that microalbuminuria is associated cross-sectionally with the presence of retinopathy in diabetic patients.
The progress of the clinical symptoms of the disease despite glycaemic therapy points to address the research towards new drugs able to slow or reverse the vessel micro-abnormalities responsible for the microangiopathy typical of diabetic retinopathy. Furthermore, the similarities of the vessel lesions between diabetic retinopathy and diabetic nephropathy suggest that new molecules effective in one of the two conditions should be effective in the other pathology as well.
Sulodexide (fast moving heparin fraction 80% and dermatan sulfate 20%) is a GAG with a high trophism for vessel wall. Clinical studies showed its efficacy in decreasing both microalbuminuria and macroalbuminuria in diabetic patients, suggesting that it could be able to slowdown the nephropathy progression, actually by partially restoring the glomerular GAGs content.
Preliminary observations regarding the use of Sulodexide in patients suffering from diabetic retinopathy show significant reduction in hard exudates, thus indirectly pointing out a benefit of this GAG at the retinal capillary level.
Based on the above mentioned physiopathological considerations and experimental findings, the investigators deem appropriate to evaluate the effects of Sulodexide on the diabetic retinopathy by the present multicentre, double-blind, placebo-controlled clinical trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sulodexide group
50 mg of sulodexide a day will be administered by oral route (1+1 capsule/day) for 360 days
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.
Placebo group
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ajou University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ji Hun Song
Assistant professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ha Kyoung Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Kangnam Sacred Heart Hospital, College of Medicine, Hallym University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kangnam Sacred Heart Hospital, Colloge of Medicine, Hallym University
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DRESS_Korea
Identifier Type: -
Identifier Source: org_study_id