Diabetes, Diabetic Macular Oedema, Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Keywords
diabetic macular oedema, diabetic macular edema, diabetic retinopathy, dexamethasone, Ozurdex, Avastin, bevacizumab, DME, DMO
Brief summary
The specific aim of the study is to test the following hypothesis: That switching between treatments from bevacizumab to Ozurdex or vice versa in eyes with diabetic macular oedema with no or incomplete response from one therapy is beneficial.
Detailed description
A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
Interventions
Avastin (Bevacizumab) administered intravitreally
Ozurdex (dexamethasone) given intravitreally
Sponsors
Allergan
University of Sydney
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eyes Previously Treated with bevacizumab: 1. Diabetic macular oedema affecting the fovea that has persisted despite ongoing, monthly intravitreal injections of bevacizumab over at least 6 months, the last being 2 to 3 months prior to the screening visit. 2. There must be an historical OCT available from 1-4 weeks after the last bevacizumab injection with retinal thickness \> 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to bevacizumab. 3. At screening, the bevacizumab treated eye must have DMO with retinal thickness \> 300 microns in the central 1mm subfield on Spectral domain OCT Eyes Previously Treated with dexamethasone: 4. Diabetic macular oedema affecting the fovea that has persisted despite two dexamethasone implants 5 or fewer months apart, the last being 5-8 months prior to the screening visit. 5. There must be an historical OCT available from 8-14 weeks after the last dexamethasone implant with retinal thickness \> 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to the dexamethasone implant. 6. At screening, the dexamethasone treated eye must have DMO with retinal thickness \> 300 microns in central 1mm subfield on Spectral domain OCT 7. Age \>= 18 years 8. Diagnosis of diabetes mellitus 9. Best corrected visual acuity of 20-78 letters (approx 6/120 -6/7.5) 10. Previous macular laser treatment, or the investigator believes laser treatment is unlikely to be helpful 11. Intraocular pressure \<22mmHg 12. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised 13. Written informed consent has been obtained.
Exclusion criteria
* Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar TA within the last 3 months, or anti vascular endothelial growth factor (VEGF) drugs: ranibizumab and aflibercept, within the last 2 months. * Cataract surgery within the last 3 months * Retinal laser treatment within the last 3 months * For eyes to be switched to Dexamethasone: Patient considered, at the judgement of the investigator, to be at-risk for syphilis, tuberculosis or other potentially infective chorioretinopathies. Patients considered at-risk may be assessed at the investigators discretion to reasonably exclude these conditions. Should these conditions be excluded, the patient may be considered for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of eyes that have central macular thickness <300 microns 6 months after switching | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in central macular thickness (CMT) as measured by OCT. | 6 months | Mean change in central macular thickness (CMT) as measured by OCT. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean change in BCVA (best corrected visual acuity) | 6 months | Proportion of eyes with a gain of 15 LogMAR letters or more * Proportion of eyes with a loss of less than 15 LogMAR letters * Proportion of eyes with gain of 5 LogMAR letters or more * Proportion of eyes with gain of 10 LogMAR letters or more |
Countries
Australia
Outcome results
None listed