Parnaparin vs Aspirin in the Treatment of Retinal Vein Occlusion (PARVO)
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ClinicalTrials.gov Identifier: NCT00732927 |
Recruitment Status :
Terminated
(slow recruitment rate)
First Posted : August 12, 2008
Last Update Posted : August 12, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Retinal Vein Occlusion | Drug: parnaparin Drug: aspirin | Phase 3 |
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 |

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 |
- incidence of functional worsening of the eye with RVO [ Time Frame: 6 months ]
- proportion of cases requiring laser treatment [ Time Frame: 6 months ]
- incidence of recurrent RVO [ Time Frame: 6 months ]
- incidence of major and minor bleeding events [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732927
Italy | |
University Of Insubria | |
Varese, Italy, 21100 |
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 |
Responsible Party: | Walter Ageno, University of Insubria |
ClinicalTrials.gov Identifier: | NCT00732927 |
Other Study ID Numbers: |
FLU/OVR/001/2001 |
First Posted: | August 12, 2008 Key Record Dates |
Last Update Posted: | August 12, 2008 |
Last Verified: | August 2008 |
thrombosis, vein, retina |
Retinal Vein Occlusion Retinal Diseases Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Aspirin Parnaparin 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 |