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
Royal Victorian Eye and Ear Hospital
100 participants
Feb 29, 2012
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
Inclusion Criteria2
- Clinically significant macular oedema involving the fovea of the study eye at baseline OR which has occured within 24 months of study entry OR microaneurysms within the foveal avascular zone which are not amenable to treatment with laser
- Cataract in the study eye which requires extraction in the opinion of the investigator
Exclusion Criteria11
- Glaucoma with visual field defects or uncontrolled glaucoma
- Past history of intraocular pressure rise >35mmHg following steroid treatment
- Significant macular ischemia
- Visual acuity of <6/60 in the fellow eye
- Known allergies to the study medications
- Systemic treatment with steroids >5mg prednisolone (or equivalent) daily
- Intercurrent severe systemic disease or ocular infection
- Women of childbearing potential not using adequate contraception or women who are breastfeeding
- Intravitreal triamcinolone within 10 weeks of study entry
- Intravitreal Avastin within 3 weeks of study entry
- Argon laser photocoagulation within 3 months prior to study entry
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Interventions
Arm 1: Avastin (bevacizumab) 1.25mg intravitreal injection, single dose administered immediately following cataract surgery
Locations(1)
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ACTRN12611000888965