- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01787669
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)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2000
- Sydney Eye Hospital
-
-
Victoria
-
Melbourne, Victoria, Australia, 3002
- Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital)
-
-
Western Australia
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Perth, Western Australia, Australia, 6009
- Lions Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Avastin (bevacizumab)
Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria
|
Avastin (Bevacizumab) administered intravitreally
|
ACTIVE_COMPARATOR: Ozurdex (dexamethasone)
single dose at baseline and repeat dose when required according to defined re-treatment criteria
|
Ozurdex (dexamethasone) given intravitreally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of eyes that have central macular thickness <300 microns 6 months after switching
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in central macular thickness (CMT) as measured by OCT.
Time Frame: 6 months
|
Mean change in central macular thickness (CMT) as measured by OCT.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in BCVA (best corrected visual acuity)
Time Frame: 6 months
|
Proportion of eyes with a gain of 15 LogMAR letters or more
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Samantha FRASER-BELL, SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Macular Degeneration
- Retinal Diseases
- Diabetic Retinopathy
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Bevacizumab
Other Study ID Numbers
- SwitchDMO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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