Trial of Switching Between Intravitreal Bevacizumab (Avastin®)& Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
SwitchDMO
A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
1 other identifier
interventional
19
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes
Started Jun 2013
Longer than P75 for phase_2 diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2013
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 13, 2018
November 1, 2018
3.6 years
February 6, 2013
November 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of eyes that have central macular thickness <300 microns 6 months after switching
6 months
Secondary Outcomes (1)
Mean change in central macular thickness (CMT) as measured by OCT.
6 months
Other Outcomes (1)
Mean change in BCVA (best corrected visual acuity)
6 months
Study Arms (2)
Avastin (bevacizumab)
ACTIVE COMPARATORIntravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria
Ozurdex (dexamethasone)
ACTIVE COMPARATORsingle dose at baseline and repeat dose when required according to defined re-treatment criteria
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sydneylead
- Allergancollaborator
Study Sites (3)
Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital)
Melbourne, Victoria, 3002, Australia
Lions Eye Institute
Perth, Western Australia, 6009, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samantha FRASER-BELL
SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2013
First Posted
February 8, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2017
Study Completion
October 1, 2017
Last Updated
November 13, 2018
Record last verified: 2018-11