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

• Conditions: Diabetic macular oedema; Level: LLTClassification code 10057915Term: Diabetic Macular Oedema

• Registration Number: EUCTR2010-021722-35-GB
• Lead Sponsor: Moorfields Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-18
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

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

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
diabetes
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.
7. Ability to return for study visits.
8. Visual acuity in fellow eye = 2/60.
9. Fellow eye has no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 12 months.
10. Ability to give informed consent throughout the duration of the study.

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

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.
10. Proliferative diabetic retinopathy in the study eye.
11. A condition that, in the opinion of the investigator, would preclude participation in the study.
12. Haemoglobin A1c > 11.0 mmol
13. A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
14. Blood pressure >170/100 (i.e. systolic above 170 or diastolic above 110). If blood pressure is brought below 170/100 by anti-hypertensive treatment, subject can become eligible.
15. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation.
16. Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline. 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.
17. Participation 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. Note: subjects cannot receive another investigational drug while participating in the study.
18. Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation.
19. Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation.
20. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following randomisation.
21. Aphakia.
22. Uncontrol

Study & Design

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