Comparison between injections into the eye ( drug Avastin) with 'pretend' injections in diabetic patients in whom no further treatment is currently available in clinic when they have developed swelling of the centre of the macular associated with lack of blood supply.

• Conditions: Therapeutic area: Diseases [C] - Eye Diseases [C11]; Ischaemic Diabetic Macular Oedema; MedDRA version: 14.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10012688Term: Diabetic retinal oedemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10012661Term: Diabetic eye diseaseSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10054372Term: Diabetic retinal edemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10038925Term: Retinopathy diabeticSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: HLTClassification code 10012657Term: Diabetic complications ophthalmicSystem Organ Class: 10014698 - Endocrine disorders

• Registration Number: EUCTR2011-003304-20-GB
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-17
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

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

Inclusion Criteria

General Inclusion Criteria
•Age >= 18 years and less than 75 years
•Diagnosis of diabetes mellitus (type 1 or type 2)
•Able and willing to provide informed consent
Study Eye Inclusion Criteria
The subject must have one eye meeting ALL of the inclusion criteria and NONE of the exclusion criteria listed below.
•Best corrected ETDRS visual acuity LogMAR (and approximate Snellen equivalent), between 0.47-1.30, 10 working days of randomization. (Equivalent to 6/18 – 3/60)
•On clinical exam, definite retinal thickening due to diabetic macular oedema involving the centre of the macula.
•OCT central subfield >=250 µm within 10 working days of randomization.
•In the opinion of the examining ophthalmologist laser treatment is ineffective or contraindicated because of the state of the Foveal avascular zone (reflecting at least moderate macular ischaemia) on fluorescein angiography. At the point when the ophthalmologist enters into the hospital medical notes that ths individual is not to have further laser treatment, the patient may be considered for inclusion into this study.
•Patients with an enlarged foveal avascular zone (FAZ) of diameter =1000 µm or a non-intact perifoveal capillary ring at the margin of the FAZ with FAZ 700-1000 µm in the transit phase of FFA will be defined as having macular ischaemia.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

General Exclusion Criteria
•Unstable cardiovascular disease or significant renal disease, (defined as a history of chronic renal failure requiring dialysis or kidney transplant).
•Known allergy to any component of any study drug.
•Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
•Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
•Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
•For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
•Any anti-VEGF treatment to either eye at any time.

Study Eye Exclusion Criteria
•Insufficient patient cooperation to allow adequate fundus photographs.
•Other causes of macular oedema
•Presence of an ocular disease that in the opinion of the investigator, is responsible for visual loss (e.g. sub-foveal atrophy, optic atrophy, dense subfoveal hard exudates.)
•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).
•History of major ocular surgery (including vitrectomy, cataract extraction) within prior 4 months.
•Insufficient Media clarity to allow adequate fundus photographs.
•History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
•History of panretinal photocoagulation (PRP) within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
•History of YAG capsulotomy performed within 2 months prior to randomization.
•Aphakia.
•Intraocular pressure >= 25 mmHg.

Study & Design

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