Parnaparin vs Aspirin in the Treatment of Retinal Vein Occlusion

Retinal Vein Occlusion Clinical Trial

— PARVO  

Official title:

Parnaparin Versus Aspirin in the Treatment of Retinal Vein Occlusion. A Randomized, Double Blind, Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00732927
• Other study ID #: FLU/OVR/001/2001
• Status: Terminated
• Phase: Phase 3
• First received: August 7, 2008
• Last updated: August 7, 2008
• Start date: July 2002
• Est. completion date: September 2007

Study information

• Verified date: August 2008
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: September 2007
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Drug:
• parnaparin
vials, 6.400 IU sc twice daily for 7 days, then once daily for a total of 3 months
• aspirin
tablets, 100 mg for 3 months

Locations

Country	Name	City	State
Italy	University Of Insubria	Varese

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria	Alfa Wassermann, Bologna, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of functional worsening of the eye with RVO		6 months	No
Secondary	proportion of cases requiring laser treatment		6 months	No
Secondary	incidence of recurrent RVO		6 months	No
Secondary	incidence of major and minor bleeding events		3 months	Yes