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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01787669




Registration number
NCT01787669
Ethics application status
Date submitted
6/02/2013
Date registered
8/02/2013
Date last updated
13/11/2018

Titles & IDs
Public title
Trial of Switching Between Intravitreal Bevacizumab (Avastin®)& Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
Scientific title
A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
Secondary ID [1] 0 0
SwitchDMO
Universal Trial Number (UTN)
Trial acronym
SwitchDMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetic Macular Oedema 0 0
Diabetic Macular Edema 0 0
Diabetic Retinopathy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avastin (Bevacizumab)
Treatment: Drugs - Ozurdex (dexamethasone)

Active comparator: Avastin (bevacizumab) - Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria

Active comparator: Ozurdex (dexamethasone) - single dose at baseline and repeat dose when required according to defined re-treatment criteria


Treatment: Drugs: Avastin (Bevacizumab)
Avastin (Bevacizumab) administered intravitreally

Treatment: Drugs: Ozurdex (dexamethasone)
Ozurdex (dexamethasone) given intravitreally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of eyes that have central macular thickness <300 microns 6 months after switching
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Mean change in central macular thickness (CMT) as measured by OCT.
Timepoint [1] 0 0
6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital) - Melbourne
Recruitment hospital [3] 0 0
Lions Eye Institute - Perth
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Allergan
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01787669
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Samantha FRASER-BELL
Address 0 0
SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01787669