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

• Conditions: Diabetic macular oedema; MedDRA version: 9.1Level: LLTClassification code 10057915Term: Diabetic macular oedema

• Registration Number: EUCTR2007-000847-89-GB
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
7At least one prior macular laser therapy.
8Intraocular pressure less than 30 mmHg.
9Written informed consent
10Ability to return for study visits
11Vision in fellow eye of 6/60 or better
12Fellow eye has no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 3 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
6Anticipated need for PRP in the 6 months following randomisation.
7A condition that, in the opinion of the investigator, would preclude participation in the study.
•Haemoglobin A1c > 11.0 mmol
•A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
•Blood pressure >180/110 (i.e. systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
•Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation.
•Major surgery within 28 days prior to randomisation or major surgery planned during the next 6 months. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
8Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry.
9Note: subjects cannot receive another investigational drug while participating in the study.
10Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation.
11These drugs cannot be used during the study.
12Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the study period including 3 months after study cessation.
13Previous pars plana vitrectomy.
14History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, et

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified