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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avastin (bevacizumab) | Active Comparator | Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria |
|
| Ozurdex (dexamethasone) | Active Comparator | single dose at baseline and repeat dose when required according to defined re-treatment criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin (Bevacizumab) | Drug | Avastin (Bevacizumab) administered intravitreally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eyes that have central macular thickness <300 microns 6 months after switching | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in central macular thickness (CMT) as measured by OCT. | Mean change in central macular thickness (CMT) as measured by OCT. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in BCVA (best corrected visual acuity) | Proportion of eyes with a gain of 15 LogMAR letters or more
| 6 months |
Inclusion Criteria:
Eyes Previously Treated with bevacizumab:
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.
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.
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:
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.
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.
At screening, the dexamethasone treated eye must have DMO with retinal thickness > 300 microns in central 1mm subfield on Spectral domain OCT
Age >= 18 years
Diagnosis of diabetes mellitus
Best corrected visual acuity of 20-78 letters (approx 6/120 -6/7.5)
Previous macular laser treatment, or the investigator believes laser treatment is unlikely to be helpful
Intraocular pressure <22mmHg
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
Written informed consent has been obtained.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samantha FRASER-BELL | SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia | ||
| Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital) |
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| Ozurdex (dexamethasone) |
| Drug |
Ozurdex (dexamethasone) given intravitreally |
|
| Melbourne |
| Victoria |
| 3002 |
| Australia |
| Lions Eye Institute | Perth | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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