Diabetic macular oedema MedDRA version: 9.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: BEVACIZUMABUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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: • 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) 3 Best corrected visual acuity in the study eye between ETDRS Snellen equivalent of 6/60 and 6/12 within 8 days of randomisation 4 On 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. 5 Clinically significant macular oedema for less than 2 years. 6 Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs. 7 At least one prior macular laser therapy. 8 Intraocular pressure less than 30 mmHg. 9 Written informed consent 10 Ability to return for study visits 11 Vision in fellow eye of 6/60 or better 12 Fellow 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
Exclusion criteria: The following exclusions apply to the study eye only (i.e., they may be present for the non study eye): 1 Macular ischaemia (FAZ > 1000?m in diameter or severe perifoveal intercapillary loss in IVFA). See appendix 6. 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 • 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). 4 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). 5 History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation. 6 Anticipated need for PRP in the 6 months following randomisation. 7 A 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. 8 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. 9 Note: subjects cannot receive another investigational drug while participating in the study. 10 Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation. 11 These drugs cannot be used during the study. 12 Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the study period including 3 months after study cessation. 13 Previous pars plana vitrectomy. 14 History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, et
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to study the efficacy and safety of intravitreal bevacizumab in improving visual acuity in diabetic patients with persistent (despite laser treatment) clinically significant macula oedema. Primary endpoint: Comparison of mean ETDRS BCVA at 12 months between the bevacizumab and laser arms.;Secondary Objective: Secondary endpoints:Comparison between the avastin and laser arms in 1. Mean macular thickness 2. proportion with gain of 15 ETDRS letters or more (improvement) 3. proportion with loss less than 15 ETDRS letters (stabilization) 4. Mean change in ETDRS acuity 5. Gain of 5 letters or more Safety Endpoints: Comparison between the avastin and laser arms in 1. mean change in ETDRS stage of intercapillary non perfusion 2. mean change in maximum diameter of foveal avascular zone 2. incidence and severity of ocular adverse events 3. incidence and severity of non ocular adverse events;Primary end point(s): Comparison of mean ETDRS BCVA at 12 months between the bevacizumab and laser arms | — |
Countries
United Kingdom
Outcome results
None listed