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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00370851
Enrollment
82
Registered
2006-09-01
Start date
2006-08-31
Completion date
2008-06-30
Last updated
2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Disease

Keywords

intravitreal Avastin, BRVO, Macular edema

Brief 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

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.

Interventions

Intravitreal injection of 125 mg Avastin

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuityAt 12 week
Macular thickness by OCTAt 12 week

Secondary

MeasureTime frame
Need for macular photocuagulationAt 12th week
Incidence of new vessel formationAt 12th week

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026