RecruitingPhase 2ACTRN12611000888965

Avastin versus Triamcinolone for Diabetic Macular Edema at the time of Cataract Surgery

Randomised, double-masked, controlled trial of intravitreal Avastin (bevacizumab) versus Triesence (triamcinolone) at the time of cataract surgery on the visual outcomes for patients with diabetic macular oedema


Sponsor

Royal Victorian Eye and Ear Hospital

Enrollment

100 participants

Start Date

Feb 29, 2012

Study Type

Interventional

Conditions

Summary

This study will compare two medications (Avastin (bevacizumab) and Triesence (Triamcinolone) given at the time of cataract surgery for patients with, or at high risk of developing, diabetic macular oedema. Patients will be seen monthly and outcomes include visual acuity, centra macular thickenss, time to retreatment and assesment of adverse events.


Eligibility

Sex: Both males and femalesMin Age: 19 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two injections — bevacizumab (Avastin) and triamcinolone (Triesence) — given at the time of cataract surgery in people with diabetic macular edema (swelling at the center of the retina caused by diabetes). Both medications help reduce swelling and protect vision. Researchers want to find out which one works better and lasts longer after the cataract operation. You may be eligible if: - You are 19 years or older - You have diabetes and have significant macular swelling or microaneurysms near the center of your vision - You need cataract surgery in the affected eye You may NOT be eligible if: - You have glaucoma with vision field loss or poorly controlled eye pressure - Your eye pressure rose above 35 mmHg after previous steroid treatment - You have significant lack of blood supply to the macula - Your vision in the other eye is very poor (worse than 6/60) - You are allergic to either study medication - You are a woman of childbearing potential not using contraception, or you are breastfeeding - You have had an intravitreal injection of triamcinolone within 10 weeks or Avastin within 3 weeks 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

Arm 1: Avastin (bevacizumab) 1.25mg intravitreal injection, single dose administered immediately following cataract surgery

Arm 1: Avastin (bevacizumab) 1.25mg intravitreal injection, single dose administered immediately following cataract surgery


Locations(1)

Australia

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