A multicentre Phase III double-masked randomised controlled non-inferiority trial comparing the clinical and cost effectiveness of intravitreal therapy with ranibizumab (Lucentis) vs aflibercept (Eylea) vs bevacizumab (Avastin) for macular oedema due to central retinal vein occlusion

Moorfields Eye Hospital (UK)0 sites463 target enrollmentNovember 26, 2014

Overview

Registry

who.int

Start Date

November 26, 2014

End Date

November 30, 2018

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Moorfields Eye Hospital (UK)

•1\. Subjects of either sex aged \= 18 years
•2\. Clinical diagnosis of centre\-involving macular oedema (MO) due to CRVO
•3\. CRVO of \= 12 months duration
•4\. Best corrected visual acuity in the study eye \= 19 and \= 73 ETDRS letters (approximate Snellen VA 3/60 to VA 6/12\)
•5\. Best corrected visual acuity in the non\-study eye \= 14 ETDRS letters (approximate Snellen VA \= 2/60\).
•6\. SD\-OCT central subfield thickness (CST) \> 320µm (Spectralis) predominantly due to MO secondary to CRVO in the study eye. See appendix 1 for equivalent CST value for alternative SD\-OCT machines.
•7\. Media clarity, pupillary dilatation and subject cooperation sufficient for adequate fundus imaging of the study eye
•8\. In cases of bilateral CRVO, if both eyes are potentially eligible, unless the patient prefers otherwise the worst seeing eye will be recruited

•Current exclusion criteria as of 13/08/2018:
•The following apply to the study eye only and to the non\-study eye only where specifically stated:
•1\. Macular oedema considered to be due to a cause other than CRVO (e.g. diabetic macular oedema, Irvine\-Gass syndrome).
•2\. An ocular condition is present that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. vitreomacular traction)
•3\. Any previously documented diabetic retinopathy or diabetic macular oedema in the study eye at baseline clinical examination of the study eye.
•4\. Moderate or severe non proliferative diabetic retinopathy (NPDR) or quiescent, treated or active proliferative diabetic retinopathy (PDR) or macular oedema in the non\-study eye. Note: Mild NPDR only is permissible in the non\-study eye.
•5\. History of treatment for MO due to CRVO in the past 90 days with intravitreal or peribulbar corticosteroids or in the last 60 days with anti\-VEGF drugs or \>6 prior anti\-VEGF treatments in the previous 12 months.
•6\. Active iris or angle neovascularisation, neovascular glaucoma, untreated NVD, NVE and vitreous haemorrhage or treatment for these conditions in the last 1 month.
•7\. Uncontrolled glaucoma \[\>30mmHg], either untreated or on anti\-glaucoma medication at screening.
•8\. Any active periocular or intraocular infection or inflammation (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis).