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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01298076




Registration number
NCT01298076
Ethics application status
Date submitted
31/08/2010
Date registered
17/02/2011
Date last updated
3/06/2015

Titles & IDs
Public title
Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
Scientific title
A Multicentre Randomised Clinical Trial of Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
Secondary ID [1] 0 0
2009-01024
Secondary ID [2] 0 0
NHMRC project 632667
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Retinopathy 0 0
Macular Edema 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 - bevacizumab
Treatment: Drugs - dexamethasone

Active Comparator: AVASTIN - intravitreal bevacizumab

Active Comparator: OZURDEX - intravitreal dexamethasone


Treatment: Drugs: bevacizumab
Anti-VEGF drug for intravitreal injection

Treatment: Drugs: dexamethasone
Slow-release steroid formulation for intravitreal injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual acuity gain - The comparison of the proportion of eyes gaining 10 letters of visual acuity between the bevacizumab (Avastin®) and dexamethasone (Ozurdex™) implant arms after 104 weeks.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Visual acuity change - Change in visual acuity compared with the pre-injection level
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
OCT change - Change in retinal thickness demonstrated on optical coherence tomography(OCT)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Laser requirement - Number of laser treatments required for the treatment of macular oedema
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Patient satisfaction - Patient satisfaction with treatment
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Safety - Mean change in maximum diameter of foveal avascular zone
Incidence and severity of ocular adverse events
Incidence and severity of non ocular adverse events
Timepoint [5] 0 0
2 years

Eligibility
Key inclusion criteria
- Age >= 18 years

- Diagnosis of diabetes mellitus types 1 or 2

- Diabetic macular oedema affecting the fovea in one or both eyes (phakic or
pseudophakic) for which laser treatment is unlikely to be helpful in the opinion of
the centre chief investigator

- Best corrected visual acuity of 17-72 letters (6/12 -6/120)

- Retinal thickness > 250 micron in central 1mm subfield on Stratus (time domain) OCT
and 300 on Spectral domain OCT

- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known allergy to Ozurdex, Avastin or agents used in the study

- Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing
potential and not using reliable means of contraception

- Glaucoma which is uncontrolled or is controlled but with more than one medication or
with only one medication and with glaucomatous field defects

- Loss of vision due to other causes (e.g. age related macular degeneration, myopic
macular degeneration, retinal vein occlusion)

- Macular oedema due to other causes

- An ocular condition that would prevent visual acuity improvement despite resolution of
oedema (such as foveal atrophy or substantial premacular fibrosis)

- Treatment with IVTA within the last 6 months or peribulbar TA within the last 3 months
or bevacizumab within the last 2 months.

- Cataract surgery within the last 6 months

- Retinal laser treatment within the last 3 months

- History of herpes virus infection in study eye

- Media opacity including cataract that already precludes adequate macular photography
and laser treatment, or cataract that is likely to require surgery within 2 years

- Known allergies to dexamethasone or bevacizumab

- Patient is already receiving systemic steroid treatment > 5mg prednisolone daily or
equivalent)

- Intercurrent severe disease such as septicemia, any condition which would affect
follow-up or photographic documentation (e.g. geographical, psycho-social)

- History of chronic renal failure requiring dialysis or renal transplant

- Blood pressure >180/110

- Patient has a condition or is in a situation that in the investigator's opinion may
put the patient at significant risk, may confound the study results, or may interfere
significantly with the patient's participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Save Sight Institute - Sydney
Recruitment hospital [2] 0 0
South West Retina - Sydney
Recruitment hospital [3] 0 0
Centre for Eye Research Australia - Melbourne
Recruitment hospital [4] 0 0
Lions Eye Institute - Perth
Recruitment postcode(s) [1] 0 0
2001 - Sydney
Recruitment postcode(s) [2] 0 0
2170 - Sydney
Recruitment postcode(s) [3] 0 0
3002 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The specific aims of the study are to test the following hypotheses:

- That there is a difference in change in visual acuity resulting from treatment with
intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced
macular oedema

- That there is a difference in degree of resolution of macular oedema resulting from
treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with
advanced macular oedema

- That both intravitreal bevacizumab and dexamethasone implants have a manageable and
acceptable safety profile in eyes with diabetic macular oedema
Trial website
https://clinicaltrials.gov/show/NCT01298076
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark C Gillies, Professor
Address 0 0
University of Sydney
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
Other publications