Diabetic macula oedema: A prospective randomised study comparing the detailed functional and anatomical changes of repeated pan anti-VEGF therapy with ranibizumab versus conventional macular laser therapy. - Diabetic macular oedema & ranibizumab; detailed functional analysis

Moorfields Eye Hospital0 sitesAugust 18, 2010

DrugsLucentis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Moorfields Eye Hospital
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 18, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Moorfields Eye Hospital

Eligibility Criteria

Inclusion Criteria

•1\.Patients of either sex aged 18 years or over.
•2\.Diagnosis of diabetes mellitus (type 1 or type 2\). Any one of the following will be considered to be sufficient evidence that diabetes is present:
•i. Current regular use of insulin for the treatment of diabetes
•ii. Current regular use of oral anti\-hyperglycaemic agents for the treatment of
•iii. Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for
•Diagnosis of Diabetes)
•3\.Best corrected visual acuity in the study eye between 55 and 79 ETDRS letters at 1 metre (Snellen equivalent \= 6/24 and \= 6/9\) within 14 days of randomisation.
•4\. On clinical exam, retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield \= 300 microns within 14 days of randomisation.
•5\. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
•6\. Intraocular pressure less than 30 mmHg.

Exclusion Criteria

•1\. Macular ischaemia (FAZ \> 1000?m in diameter or severe perifoveal intercapillary loss on 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: (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.
•3\. Co\-existent ocular disease.
•4\. 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).
•5\. 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.).
•6\.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 6/12 or worse if eye was otherwise normal).
•7\.History 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).
•8\.History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation.
•9\. Anticipated need for PRP in the 6 months following randomisation.