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

• ClinicalTrials.gov Identifier: NCT00732927
• Recruitment Status: Terminated
• First Posted: August 12, 2008
• Last Update Posted: August 12, 2008
• Sponsor: Università degli Studi dell'Insubria
• Collaborator: Alfa Wassermann, Bologna, Italy
• Information provided by: Università degli Studi dell'Insubria

Study Description

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

Study Design

• 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

Arms and Interventions

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; aspirin	Drug: aspirin; tablets, 100 mg for 3 months

Outcome Measures

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 ]

Eligibility Criteria

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ageno W, Cattaneo R, Manfredi E, Chelazzi P, Venco L, Ghirarduzzi A, Cimino L, Filippucci E, Ricci AL, Romanelli D, Incorvaia C, D'Angelo S, Campana F, Molfino F, Scannapieco G, Rubbi F, Imberti D. Parnaparin versus aspirin in the treatment of retinal vein occlusion. A randomized, double blind, controlled study. Thromb Res. 2010 Feb;125(2):137-41. doi: 10.1016/j.thromres.2009.05.007. Epub 2009 May 27.

• Responsible Party: Walter Ageno, University of Insubria
• ClinicalTrials.gov Identifier: NCT00732927
• Other Study ID Numbers: FLU/OVR/001/2001
• First Posted: August 12, 2008
• 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:

Retinal Vein Occlusion; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Aspirin; Parnaparin; Heparin, Low-Molecular-Weight; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; 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; Antipyretics; Anticoagulants