RecruitingPhase 3ACTRN12611000302954

Branch Retinal Vein Occlusion Treatment Trial

A 12 month, phase 3, single-centre, randomised trial to compare the the safety and efficacy of a 125mg/0.05ml Bevacizumab intravitreal injection to macular grid laser therapy in the treatment of macular edema following Branch Vein Retinal Occlusion (BRVO) .


Sponsor

Royal Adelaide Hospital

Enrollment

22 participants

Start Date

Dec 17, 2008

Study Type

Interventional

Conditions

Summary

The primary objective of this randomised controlled trial is to evaluate the efficacy of intravitreal Bevacizumab in the treatment of macular oedema following branch retinal vein occlusion (BRVO) and compare it with present day standard treatment, macular laser.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for a condition called branch retinal vein occlusion (BRVO), where a smaller vein in the retina becomes blocked, causing vision loss due to swelling. The two treatments being compared are an injection of Bevacizumab (a drug that reduces abnormal blood vessel growth) into the eye, versus laser treatment (the current standard approach). The goal is to find out which treatment improves vision better. You may be eligible if: - You are 18 years or older - You have been diagnosed with branch retinal vein occlusion for at least 3 months - Your best corrected vision is worse than 20/40 in the affected eye - You have significant retinal swelling on imaging - Your kidney function is adequate You may NOT be eligible if: - You have had certain previous eye surgeries including glaucoma surgery or corneal transplant - You have had laser treatment to the affected area in the past month - You have active eye inflammation or infection - You are pregnant or breastfeeding - You have uncontrolled glaucoma Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Bevacizumab is a recombinant humanised monoclonal antibody to vascular epithelial growth factor (VEGF) designed for IV administration and approved for treatment of colorectal cancer. It has recently

Bevacizumab is a recombinant humanised monoclonal antibody to vascular epithelial growth factor (VEGF) designed for IV administration and approved for treatment of colorectal cancer. It has recently emerged as a novel therapeutic strategy for retinal diseases, especially age-related macular degeneration, and, in retrospective short-term studies, has also proven to be effective in central retinal and branch retinal vein occlusion. None of the clinical and experimental studies published so far have found any drug-related toxic effects on any retinal structures. Patients will receive a minimum of 3 doses of Bevacizumab 1.25 mg via intravitreal injection to the eye at monthly intervals, then as required for up to 12 months.The procedure on each occasion will take 5 minutes.


Locations(1)

Australia

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ACTRN12611000302954