Parnaparin vs Aspirin in the Treatment of Retinal Vein Occlusion (PARVO)
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Parnaparin Versus Aspirin in the Treatment of Retinal Vein Occlusion. A Randomized, Double Blind, Controlled Study |
- incidence of functional worsening of the eye with RVO [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- proportion of cases requiring laser treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- incidence of recurrent RVO [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- incidence of major and minor bleeding events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Experimental: 1
parnaparin, low molecular weight heparin
|
Drug: parnaparin
vials, 6.400 IU sc twice daily for 7 days, then once daily for a total of 3 months
|
|
Active Comparator: 2
aspirin
|
Drug: aspirin
tablets, 100 mg for 3 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18 and 85 years
- A body weight of greater than 50 Kg
- A requirement that no more than 15 days had passed between symptomatic presentation, confirmation of RVO and entry into the study.
Exclusion Criteria:
- Modification of the optic media transparency that could compromise the evaluation of fluorescein angiography, such as cataract or corneal degeneration
- History of major ocular surgery (with the exclusion of cataract extraction)
- Previous RVO
- Other ocular conditions that, in the opinion of the investigator, could have affected macular edema or altered visual acuity during the course of the study - Contraindications to the study drugs (e.g. major bleeding or neurosurgical procedures in the previous 3 months, serum creatinine levels of greater than 2.0 mg/dL, severe liver insufficiency, platelet count < 100,000 mm3, known active peptic gastric ulcer)
- Active malignancy
- Pregnancy
- Inability to attend for follow up or anticipated non-compliance
- Ongoing treatment with aspirin or anticoagulant drugs at the time of RVO diagnosis
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00732927
| Italy | |
| University Of Insubria | |
| Varese, Italy, 21100 | |
| Study Director: | Davide Imberti, MD | Ospedale di Piacenza | |
| Study Director: | Roberto Cattaneo, MD | Ospedale di Gallarate | |
| Study Chair: | Walter Ageno, MD | Università degli Studi dell'Insubria |
More Information
No publications provided by Università degli Studi dell'Insubria
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Walter Ageno, University of Insubria |
| ClinicalTrials.gov Identifier: | NCT00732927 History of Changes |
| Other Study ID Numbers: | FLU/OVR/001/2001 |
| Study First Received: | August 7, 2008 |
| Last Updated: | August 7, 2008 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Università degli Studi dell'Insubria:
|
thrombosis, vein, retina |
Additional relevant MeSH terms:
|
Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases |
Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis |
ClinicalTrials.gov processed this record on March 03, 2015