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Bevacizumab for Central Retinal Vein Occlusion Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital
ClinicalTrials.gov Identifier:
NCT00906685
First received: May 20, 2009
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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

Primary Outcome Measures:
  • The proportion of patients gaining 15 ETDRS letters or more [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in foveal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cases of neovascular glaucoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT00906685     History of Changes
Other Study ID Numbers: ACRVO
Study First Received: May 20, 2009
Last Updated: November 21, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by 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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013