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Bevacizumab for Central Retinal Vein Occlusion Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00906685
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital

Brief Summary:
Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Drug: bevacizumab Drug: Sham bevacizumab injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
Study Start Date : May 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: Intravitreal bevacizumab Drug: bevacizumab
Intravitreal injection of 1.25 mg bevacizumab

Sham Comparator: Sham injection Drug: Sham bevacizumab injection
Sham intravitreal injection

Primary Outcome Measures :
  1. The proportion of patients gaining 15 ETDRS letters or more [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in foveal thickness [ Time Frame: 6 months ]
  2. Cases of neovascular glaucoma [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CRVO with duration < 6 months
  • Visual acuity of 20/800 to 20/50

Exclusion Criteria:

  • CRVO with duration of > 6 months
  • previous treatment with anti-angiogenic drugs

Information from the National Library of Medicine

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 identifier (NCT number): NCT00906685

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St Eriks Eye Hospital
Stockholm, Sweden, 11282
Sponsors and Collaborators
Anders Kvanta
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Principal Investigator: Anders Kvanta, MD, PhD St Eriks Eye Hospital

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Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital Identifier: NCT00906685     History of Changes
Other Study ID Numbers: ACRVO
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Anders Kvanta, St. Erik Eye Hospital:
Macular edema

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors