Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370851
First received: August 31, 2006
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE


Condition Intervention Phase
Retinal Disease
Drug: Avastin (Bevacizumab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: At 12 week ] [ Designated as safety issue: Yes ]
  • Macular thickness by OCT [ Time Frame: At 12 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Need for macular photocuagulation [ Time Frame: At 12th week ] [ Designated as safety issue: Yes ]
  • Incidence of new vessel formation [ Time Frame: At 12th week ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intravitreal injection of Avastin
Drug: Avastin (Bevacizumab)
Intravitreal injection of 125 mg Avastin
Sham Comparator: 2 Drug: Avastin (Bevacizumab)
Intravitreal injection of 125 mg Avastin

Detailed Description:

After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with acute BRVO with less than three month duration

Exclusion Criteria:

  • vision less than 20/320 and vison more than 20/50
  • duration more than 3 months
  • history of glaucoma and diabetic retinopathy
  • any media opacity that prevent funduscopy
  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: NCT00370851

Locations
Iran, Islamic Republic of
Siamak Moradian, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti Medical University
Investigators
Principal Investigator: Siamak Moradian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided by Shahid Beheshti Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00370851     History of Changes
Other Study ID Numbers: 8532
Study First Received: August 31, 2006
Last Updated: November 23, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
intravitreal Avastin
BRVO
Macular edema

Additional relevant MeSH terms:
Retinal Diseases
Eye 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 October 02, 2014