Ischaemic Diabetic Macular Oedema MedDRA version: 14.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10012688 Term: Diabetic retinal oedema System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10012661
Conditions
Interventions
Trade Name: Avastin
Product Name: bevacizumab
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: Bevacizumab
CAS Number: 216974-75-3
Concentration unit: mg/ml mi
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is it possible to improve visual function, prove safety and acceptability of the use of Avastin eye injections in patients with diabetic ischaemic macular oedema?;Secondary Objective: 1. Does Avastin therapy improve functional vision (based on self-reported quality of life measures)? 2. Are 6 weekly intravitreal injections acceptable (based on self-reported quality of life measures)? 3. Does Avastin therapy improve visual acuity (gain of 15 letters or more), contrast sensitivity, and reading speed, and improve relative change in macular thickness (as measured by OCT scan). 4. Is Avastin therapy in this group of patients safe? (Maintenance of foveal avascular zone, absence of toxicity on Electrophysiological tests / Humphrey 10-2 /autofluorescence/ GDx, maintenance of retinal sensitivity on microperimetry, maintenance of colour vision) 5. Is Avastin therapy in this group of patients cost-effective? (Measurement of EQ-5D scores). ;Primary end point(s): Stabilization of visual acuity (loss of less than 10 letters);Timepoint(s) of evaluation of this end point: Each subject will be followed up for 12 months. This end point will be evaluated at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Functional vision changes based on self reported quality of life measures. 2. Acceptability of 6 weekly intravitreal therapy. 3. Improvement of visual acuity (gain of 15 letters or more), contrast sensitvity and reading speed. 4. Relative change in macular thickness as measured by OCT scan. 5. Maintenance of foveal avascular zone, absence of toxicity on electrophysiology tests, autofluorecence, GDx, maintenance of retinal sensitivity on micoperimetry, maintenance of colour vision. 6. Cost-effectiveness: measurement of EQ-5D scores. ;Timepoint(s) of evaluation of this end point: Each subject will be followed up for 12 months. These secondary end points will be evaluated at 12 months | — |
Countries
United Kingdom
Outcome results
None listed