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Parnaparin vs Aspirin in the Treatment of Retinal Vein Occlusion (PARVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00732927
Recruitment Status : Terminated (slow recruitment rate)
First Posted : August 12, 2008
Last Update Posted : August 12, 2008
Alfa Wassermann, Bologna, Italy
Information provided by:
Università degli Studi dell'Insubria

Brief Summary:
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 or disease Intervention/treatment Phase
Retinal Vein Occlusion Drug: parnaparin Drug: aspirin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parnaparin Versus Aspirin in the Treatment of Retinal Vein Occlusion. A Randomized, Double Blind, Controlled Study
Study Start Date : July 2002
Actual Primary Completion Date : July 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Aspirin

Arm Intervention/treatment
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
Drug: aspirin
tablets, 100 mg for 3 months

Primary Outcome Measures :
  1. incidence of functional worsening of the eye with RVO [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. proportion of cases requiring laser treatment [ Time Frame: 6 months ]
  2. incidence of recurrent RVO [ Time Frame: 6 months ]
  3. incidence of major and minor bleeding events [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00732927

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University Of Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Alfa Wassermann, Bologna, Italy
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Walter Ageno, University of Insubria Identifier: NCT00732927    
Other Study ID Numbers: FLU/OVR/001/2001
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: August 12, 2008
Last Verified: August 2008
Keywords provided by Università degli Studi dell'Insubria:
thrombosis, vein, retina
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors