Full Title of Study: Diabetic macular oedema: a prospective randomised trial of management with intravitreal bevacizumab (Avastin) versus conventional laser therapy

Moorfields Eye Hospital NHS Foundation Trust0 sitesMarch 28, 2007

DrugsAvastin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Moorfields Eye Hospital NHS Foundation Trust
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 28, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

•1Patients of either sex aged 18 years or over
•2Diagnosis of diabetes mellitus (type 1 or type 2\). Any one of the following will be considered to be sufficient evidence that diabetes is present:
•Current regular use of insulin for the treatment of diabetes
•Current regular use of oral anti\-hyperglycaemic agents for the treatment of diabetes
•Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions)
•3Best corrected visual acuity in the study eye between ETDRS Snellen equivalent of 6/60 and 6/12 within 8 days of randomisation
•4On clinical exam, definite retinal thickening due to diabetic macular oedema involving the centre of the macula.
•OCT central subfield \>\=270 microns within 8 days of randomisation.
•5Clinically significant macular oedema for less than 2 years.
•6Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.

Exclusion Criteria

•The following exclusions apply to the study eye only (i.e., they may be present for the non study eye):
•1Macular ischaemia (FAZ \> 1000?m in diameter or severe perifoveal intercapillary loss in IVFA). See appendix 6\.
•2Macular oedema is considered to be due to a cause other than diabetic macular oedema.
•An eye should not be considered eligible if: (1\) the macular oedema is considered to be related to cataract extraction or (2\) clinical exam 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.
•3Co\-existent ocular disease
•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).
•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.).
•A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
•4History of treatment for DMO at any time in the past 3 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti\-VEGF drugs, or any other treatment).
•5History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation.