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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Retinal Disease

Treatments: Drug: Avastin (Bevacizumab)

Study type: Interventional

Funder types: Other

Identifiers

NCT00370851

8532

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

1

Experimental group

Description:

Intravitreal injection of Avastin

Treatment:

Drug: Avastin (Bevacizumab)

2

Sham Comparator group

Treatment:

Drug: Avastin (Bevacizumab)