Parnaparin vs Aspirin in the Treatment of Retinal Vein Occlusion - Full Text View

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:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Aspirin

U.S. FDA Resources

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 (Adult, Senior)
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

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 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 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

ClinicalTrials.gov processed this record on September 23, 2016

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