PARVO: Parnaparin vs Aspirin in the Treatment of Retinal Vein Occlusion

Sponsor

Università degli Studi dell'Insubria (Other)

Overall Status

Terminated

CT.gov ID

NCT00732927

Collaborator

Alfa Wassermann, Bologna, Italy (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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

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 :

Jul 1, 2002

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Sep 1, 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

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

incidence of functional worsening of the eye with RVO [6 months]

Secondary Outcome Measures

proportion of cases requiring laser treatment [6 months]
incidence of recurrent RVO [6 months]
incidence of major and minor bleeding events [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00732927

Other Study ID Numbers:

FLU/OVR/001/2001

First Posted:

Aug 12, 2008

Last Update Posted:

Aug 12, 2008

Last Verified:

Aug 1, 2008

Keywords provided by , ,

thrombosis, vein, retina

Additional relevant MeSH terms:

Retinal Vein Occlusion

Aspirin

Parnaparin

Study Results

No Results Posted as of Aug 12, 2008