DiabetesPhase 2SwitchDMONCT01787669
Trial of Switching Between Intravitreal Bevacizumab (Avastin®)& Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
A Phase 2 study testing Avastin (Bevacizumab) and Ozurdex (dexamethasone) in people with Diabetes and Diabetic Macular Oedema, run by University of Sydney at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Macular Oedema, Diabetic Macular Edema
- What is being tested?
- Avastin (Bevacizumab) and Ozurdex (dexamethasone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesAustralia
- Study dates
- Jun 2013to Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital)
Melbourne, Victoria, 3002
Lions Eye Institute
Perth, Western Australia, 6009
Sydney Eye Hospital
Sydney, New South Wales, 2000
About this study
Official title: A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
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.
Read the detailed description
A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
- Being tested
- Avastin (Bevacizumab), Ozurdex (dexamethasone)
- Keywords
- diabetic macular oedema, diabetic macular edema, diabetic retinopathy, dexamethasone, Ozurdex, Avastin, bevacizumab, DME, DMO
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin (Bevacizumab)Drug
Avastin (Bevacizumab) administered intravitreally
Ozurdex (dexamethasone)Drug
Ozurdex (dexamethasone) given intravitreally
| Study group | Role | What they receive |
|---|---|---|
| Avastin (bevacizumab) | Active comparator | Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria Receives: Drug: Avastin (Bevacizumab) |
| Ozurdex (dexamethasone) | Active comparator | single dose at baseline and repeat dose when required according to defined re-treatment criteria Receives: Drug: Ozurdex (dexamethasone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes that have central macular thickness <300 microns 6 months after switching
Measured: 6 months
Secondary outcomes (1)
Mean change in central macular thickness (CMT) as measured by OCT.
Mean change in central macular thickness (CMT) as measured by OCT.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Samantha FRASER-BELL, Principal investigator, SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787669
- Sponsor's protocol ID
- SwitchDMO
- Acronym
- SwitchDMO
- Status last verified
- Nov 2018
- First submitted
- 6 Feb 2013
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
- ClinicalTrials.gov ID
- NCT01787669
- Acronym / sponsor ID
- SwitchDMO / SwitchDMO
- Keywords
- diabetic macular oedema, diabetic macular edema, diabetic retinopathy, dexamethasone, Ozurdex, Avastin, bevacizumab, DME
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jun 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avastin (bevacizumab) | Active comparator | Drug: Avastin (Bevacizumab)Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria |
| Ozurdex (dexamethasone) | Active comparator | Drug: Ozurdex (dexamethasone)single dose at baseline and repeat dose when required according to defined re-treatment criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avastin (Bevacizumab)Avastin (Bevacizumab) administered intravitreally | Drug | Avastin (bevacizumab) |
| Ozurdex (dexamethasone)Ozurdex (dexamethasone) given intravitreally | Drug | Ozurdex (dexamethasone) |
Primary outcome
Proportion of eyes that have central macular thickness <300 microns 6 months after switching
Time frame: 6 months
1 secondary outcome
Mean change in central macular thickness (CMT) as measured by OCT.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha FRASER-BELL principal investigator
SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin (Bevacizumab) and Ozurdex (dexamethasone) in people with Diabetes and Diabetic Macular Oedema, run by University of Sydney at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eyes that have central macular thickness <300 microns 6 months after switching (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.