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

Retinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370851
• Other study ID #: 8532
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2006
• Last updated: November 23, 2009
• Start date: August 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2009
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Drug:
• Avastin (Bevacizumab)
Intravitreal injection of 125 mg Avastin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Siamak Moradian, MD	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity		At 12 week	Yes
Primary	Macular thickness by OCT		At 12 week	Yes
Secondary	Need for macular photocuagulation		At 12th week	Yes
Secondary	Incidence of new vessel formation		At 12th week	Yes