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Sponsors and Collaborators: |
Università degli Studi dell'Insubria Alfa Wassermann, Bologna, Italy |
Information provided by: | Università degli Studi dell'Insubria |
ClinicalTrials.gov Identifier: | NCT00732927 |
Retinal vein occlusion (RVO) is the second commonest retinal disease after diabetic retinopathy, and is a common cause of unilateral visual loss. There are two aims in the management of RVO: the identification of modifiable risk factors and their medical management and the recognition and management of sight-threatening complications. The management of the disease includes laser therapy and the control of systemic associated diseases. Many other treatments have been proposed but there is no evidence on their efficacy in modulating the outcome of branch or central RVO. There are currently no adequate clinical trials that have evaluated the efficacy and safety of antithrombotic agents in this setting. Antiplatelet agents are frequently used in clinical practice. Anticoagulant drugs, either heparins or coumarins, are also used in this setting as they represent the first line therapy for the treatment of venous thromboembolism. Aim of this randomized controlled study is to to compare the efficacy and safety of aspirin and of a low molecular weight heparin, parnaparin, in the treatment of RVO. Study treatment is administered for 3 months. Primary end-point of the study is the incidence of functional worsening of the eye with RVO at 6 months. Secondary efficacy outcomes are the following: proportion of cases requiring laser treatment because of the extension of the ischemic lesion and/or the presence of neovascularisation and/or macular oedema, incidence of recurrent RVO objectively documented by fluorescein angiography. Safety outcomes are defined by the incidence of major and minor bleeding events.
Condition | Intervention | Phase |
Retinal Vein Occlusion |
Drug: parnaparin Drug: aspirin |
Phase III |
MedlinePlus related topics: | Retinal Disorders |
ChemIDplus related topics: | Tretinoin Acetylsalicylic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Parnaparin Versus Aspirin in the Treatment of Retinal Vein Occlusion. A Randomized, Double Blind, Controlled Study |
Enrollment: | 67 |
Study Start Date: | July 2002 |
Study Completion Date: | September 2007 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
parnaparin, low molecular weight heparin
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Drug: parnaparin
vials, 6.400 IU sc twice daily for 7 days, then once daily for a total of 3 months
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2: Active Comparator
aspirin
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Drug: aspirin
tablets, 100 mg for 3 months
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |||||
University Of Insubria | |||||
Varese, Italy, 21100 |
Università degli Studi dell'Insubria |
Alfa Wassermann, Bologna, Italy |
Study Director: | Davide Imberti, MD | Ospedale di Piacenza |
Study Director: | Roberto Cattaneo, MD | Ospedale di Gallarate |
Study Chair: | Walter Ageno, MD | University of Insubria |
Responsible Party: | University of Insubria ( Walter Ageno ) |
Study ID Numbers: | FLU/OVR/001/2001 |
First Received: | August 7, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00732927 |
Health Authority: | Italy: Ethics Committee |
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