Diabetic Macular Oedema: a prospective randomised trial of management with intravitreal bevacizumab (Avastin®) versus conventional laser therapy in diabetic macula oedema

Moorfields Eye Hospital NHS Foundation Trust (UK)0 sites80 target enrollmentJuly 16, 2007

ConditionsDiabetes mellitus Nutritional, Metabolic, Endocrine Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes mellitus
Sponsor: Moorfields Eye Hospital NHS Foundation Trust (UK)
Enrollment: 80
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 16, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Moorfields Eye Hospital NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

•1\. Patients of either sex aged 18 years or over
•2\. Diagnosis of diabetes mellitus (type one or type two). Any one of the following will be considered to be sufficient evidence that diabetes is present:
•2\.1\. Current regular use of insulin for the treatment of diabetes
•2\.2\. Current regular use of oral anti\-hyperglycaemic agents for the treatment of diabetes
•2\.3\. Documented diabetes by American Diabetes Association (ADA) and/or World Health Organisation (WHO) criteria
•3\. Best corrected visual acuity in the study eye between 35 and 69 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 metres (Snellen equivalent of 6/60 or better and less than 6/12\) within 14 days of randomisation
•4\. On clinical examimation, definite retinal thickening due to diabetic macular oedema involving the centre of the macula: Optical Coherence Tomography (OCT) central subfield greater than or equal to 270 microns within 14 days of randomisation
•5\. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
•6\. At least one prior macular laser therapy
•7\. Intraocular pressure less than 30 mmHg

Exclusion Criteria

•The following exclusions apply to the study eye only (i.e., they may be present for the non\-study eye):
•1\. Macular ischaemia (Foveal Avascular Zone \[FAZ] greater than 1000 um in diameter or severe perifoveal intercapillary loss in Intravenous Fluorescein Angiography \[IVFA])
•2\. Macular oedema is considered to be due to a cause other than diabetic macular oedema. An eye should not be considered eligible if:
•2\.1\. The macular oedema is considered to be related to cataract extraction, or
•2\.2\. Clinical examination and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular oedema
•3\. Co\-existent ocular disease:
•3\.1\. An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular oedema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non\-retinal conditions, such as amblyopia)
•3\.2\. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine\-Gass Syndrome, etc.)
•3\.3\. A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal)
•4\. History of treatment for Diabetic Macula Oedema (DMO) at any time in the past three months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti\-VEGF drugs, or any other treatment)