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Bevacizumab for Central Retinal Vein Occlusion Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906685
First Posted: May 21, 2009
Last Update Posted: November 22, 2011
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.
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital
  Purpose
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 Intervention Phase
Central Retinal Vein Occlusion Drug: bevacizumab Drug: Sham bevacizumab injection Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Anders Kvanta, St. Erik Eye Hospital:

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

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

Enrollment: 60
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravitreal bevacizumab Drug: bevacizumab
Intravitreal injection of 1.25 mg bevacizumab
Sham Comparator: Sham injection Drug: Sham bevacizumab injection
Sham intravitreal injection

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00906685


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

Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT00906685     History of Changes
Other Study ID Numbers: ACRVO
First Submitted: May 20, 2009
First Posted: May 21, 2009
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Anders Kvanta, St. Erik Eye Hospital:
CRVO
anti-VEGF
Macular edema

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