Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema

Summary

The specific aims of the study are to test the following hypotheses: * That there is a difference in change in visual acuity resulting from treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced macular oedema * That there is a difference in degree of resolution of macular oedema resulting from treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced macular oedema * That both intravitreal bevacizumab and dexamethasone implants have a manageable and acceptable safety profile in eyes with diabetic macular oedema

Timeline

Start

2010-10

Primary completion

2014-09

Completion

2014-09

Publications

• Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
• Mehta H, Fraser-Bell S, Nguyen V, Lim LL, Gillies MC. The Interval between Treatments of Bevacizumab and Dexamethasone Implants for Diabetic Macular Edema Increased over Time in the BEVORDEX Trial. Ophthalmol Retina. 2018 Mar;2(3):231-234. doi: 10.1016/j.oret.2017.06.010. Epub 2017 Aug 23.
• Mehta H, Fraser-Bell S, Nguyen V, Lim LL, Gillies MC. Short-term vision gains at 12 weeks correlate with long-term vision gains at 2 years: results from the BEVORDEX randomised clinical trial of bevacizumab versus dexamethasone implants for diabetic macular oedema. Br J Ophthalmol. 2018 Apr;102(4):479-482. doi: 10.1136/bjophthalmol-2017-310737. Epub 2017 Aug 4.
• Wickremasinghe SS, Fraser-Bell S, Alessandrello E, Mehta H, Gillies MC, Lim LL. Retinal vascular calibre changes after intravitreal bevacizumab or dexamethasone implant treatment for diabetic macular oedema. Br J Ophthalmol. 2017 Oct;101(10):1329-1333. doi: 10.1136/bjophthalmol-2016-309882. Epub 2017 Feb 22.
• Aroney C, Fraser-Bell S, Lamoureux EL, Gillies MC, Lim LL, Fenwick EK. Vision-Related Quality of Life Outcomes in the BEVORDEX Study: A Clinical Trial Comparing Ozurdex Sustained Release Dexamethasone Intravitreal Implant and Bevacizumab Treatment for Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5541-5546. doi: 10.1167/iovs.16-19729.
• Mehta H, Fraser-Bell S, Yeung A, Campain A, Lim LL, Quin GJ, McAllister IL, Keane PA, Gillies MC. Efficacy of dexamethasone versus bevacizumab on regression of hard exudates in diabetic maculopathy: data from the BEVORDEX randomised clinical trial. Br J Ophthalmol. 2016 Jul;100(7):1000-1004. doi: 10.1136/bjophthalmol-2015-307797. Epub 2015 Nov 4.
• Gillies MC, Lim LL, Campain A, Quin GJ, Salem W, Li J, Goodwin S, Aroney C, McAllister IL, Fraser-Bell S. A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX study. Ophthalmology. 2014 Dec;121(12):2473-81. doi: 10.1016/j.ophtha.2014.07.002. Epub 2014 Aug 22.

Drugs

Indications