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

This study has been terminated.
(slow recruitment rate)
Sponsor:
Collaborator:
Alfa Wassermann, Bologna, Italy
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00732927
First received: August 7, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • incidence of functional worsening of the eye with RVO [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732927

Locations
Italy
University Of Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Alfa Wassermann, Bologna, Italy
Investigators
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
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 18, 2014