RecruitingPhase 2ACTRN12611000300976

Bevacizumab intravitreal injection in the treatment of patients with Central Retinal Vein Occlusion.

A 12 month, phase 2, single-centre, masked, randomised, sham-controlled trial to assess the safety and efficacy of a 1.25mg/0.05ml Bevacizumab intravitreal injection in the treatment of patients with Central Retinal Vein Occlusion (CRVO).


Sponsor

Royal Adelaide Hospital

Enrollment

22 participants

Start Date

Feb 23, 2009

Study Type

Interventional

Conditions

Summary

The primary objective of this randomized controlled trial is to evaluate the efficacy of intravitreal Bevacizumab in the treatment of macular oedema following central retinal vein occlusion.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether an injection of a drug called Bevacizumab into the eye can help treat a condition called central retinal vein occlusion (CRVO). CRVO happens when a major vein in the retina (the back of the eye) becomes blocked, causing swelling and vision loss. Bevacizumab works by blocking a protein that causes abnormal blood vessel growth and swelling. This trial compares the injection treatment to a placebo (sham) treatment to see if it improves vision. You may be eligible if: - You are 18 years or older - You have swelling in the centre of the retina (macula) caused by central retinal vein occlusion - Your vision in the affected eye is between 20/40 and 20/320 (moderate to severe vision loss) You may NOT be eligible if: - You have diabetic macular oedema - You are pregnant or breastfeeding - You have uncontrolled high blood pressure or unstable heart disease - You have had certain recent eye surgeries or active eye infections - You have uncontrolled glaucoma Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The patient will receive an intravitreal injection at baseline, week 4 and week 8. Repeat injections will be decided on an as needed basis The dosage for Bevacizumab is 1.25mg/0.05ml administered

The patient will receive an intravitreal injection at baseline, week 4 and week 8. Repeat injections will be decided on an as needed basis The dosage for Bevacizumab is 1.25mg/0.05ml administered via a intravitreal injection into the eye.The procedure will take 5 minutes in total.


Locations(1)

Australia

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ACTRN12611000300976