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Trial registered on ANZCTR


Registration number
ACTRN12618000202268
Ethics application status
Approved
Date submitted
22/11/2017
Date registered
7/02/2018
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the effectiveness and safety of two treatments (OZURDEX® intravitreal implant versus Avastin®) for diabetic eye disease in adult Indigenous patients living in Western Australia.
Scientific title
A randomised active-controlled non-inferiority trial of OZURDEX® intravitreal implant versus Avastin® intravitreal injection in Indigenous patients with or at risk of diabetic macular oedema, at the time of or following cataract surgery. (The OASIS Study)
Secondary ID [1] 293341 0
Nil known
Universal Trial Number (UTN)
U1111-1204-9415
Trial acronym
OASIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 305436 0
Condition category
Condition code
Eye 304713 304713 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 304714 304714 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.7mg intravitreal dexamethasone implant (Ozurdex) administered by a consultant ophthalmologist, or an ophthalmology fellow under consultant supervision, in operating theatres at the time of cataract surgery for phakic participants. The injection will be performed after implantation of the intraocular lens for patients undergoing cataract surgery. The case duration is expected to be approximately 20 minutes in most cases.

For pseudophakic participants, injections will be performed in outpatient treatment facilities by the same clinical staff as above. The treatment duration is expected to be 5 minutes for most pseudophakic participants.

Followup will be offered monthly with retreatment as clinically indicated. The overall intervention period for this trial will be 12 months.
Intervention code [1] 299595 0
Treatment: Drugs
Comparator / control treatment
1.25mg/0.05ml intravitreal Bevacizumab (Avastin) administered in operating theatres at the time of cataract surgery for phakic participants, and in outpatient treatment facilities for pseudophakic participants. Followup will be offered monthly with retreatment as clinically indicated. The overall intervention period for this trial will be 12 months.
Control group
Active

Outcomes
Primary outcome [1] 303921 0
Mean change in Best Corrected Visual Acuity (BCVA).
Timepoint [1] 303921 0
6 Months, 12 Months
Secondary outcome [1] 340465 0
Mean change in Central Retinal Thickness (CRT) as measured by Optical Coherence Tomography (OCT).
Timepoint [1] 340465 0
6 Months, 12 Months
Secondary outcome [2] 340466 0
Number of intravitreal injections given (by review of medical records, for injections assigned for the purposes of this study).
Timepoint [2] 340466 0
6 Months, 12 Months
Secondary outcome [3] 340467 0
Number of participants requiring laser treatment (by review of medical records for the study eye).
Timepoint [3] 340467 0
6 Months, 12 Months
Secondary outcome [4] 340468 0
Adverse events. Known adverse effects specific to this drug include increased intra-ocular pressure (IOP) and posterior subcapsular cataract formation. IOP will be measured at each visit and treated as clinically indicated..
Timepoint [4] 340468 0
12 Months

Eligibility
Key inclusion criteria
• Self-identifying Indigenous Australian.
• Adult aged 18 years and over.
• Diagnosis of diabetes mellitus (type 1 or 2).
• Best-corrected visual acuity (BCVA) of at best 6/9 to in the study eye.
• Pseudophakic – OR – phakic with significant lens opacity and scheduled to undergo
cataract surgery at the time of enrolment.
• Presence of any grade of diabetic retinopathy with:
A. Active DMO (phakic or pseudophakic patients): Centre-involving/threatening
DMO, as defined by clinical examination and OCT scan findings.
B. At risk of DMO (phakic patients only): Assessed as being at risk of post-operative
DMO based on clinical examination, OCT scan findings and investigator discretion.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Intervention in the study eye including:
- Intravitreal anti-VEGF injections within the last 6 weeks;
- Macular laser within the last 4 months;
- Intravitreal triamcinolone or triescence within the last 6 months; of time of first trial
treatment.
• History of open-angle glaucoma or steroid induced IOP elevation that required IOP-
lowering treatment or, IOP =25 (Goldmann applanation) on 2 consecutive clinic visits.
• Eyes with concurrent ocular pathology other than DMO causing visual loss.
• Women who are breastfeeding, confirmed as pregnant or planning on becoming
pregnant in the next 6-12 months.
• Participants for whom Ozurdex or Avastin treatment are contraindicated as per
Product Information:
- Active or suspected ocular/periocular infections including most viral diseases of
the cornea and conjunctiva, active epithelia herpes simplex keratitis (dendritic
keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
- Aphakic eyes with rupture of the posterior lens capsule.
- Eyes with anterior chamber intraocular lens and rupture of the posterior lens
capsule.
- Known angina, myocardial infarction, TIA or CVA in last 3 months.
- Known hypersensitivity to any components of these products

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 receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
WA

Funding & Sponsors
Funding source category [1] 297963 0
Commercial sector/Industry
Name [1] 297963 0
ALLERGAN AUSTRALIA PTY LTD
Address [1] 297963 0
Level 4
810 Pacific Highway
Gordon, NSW 2072
Australia
Country [1] 297963 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
LIONS EYE INSTITUTE LTD
Address
2 Verdun St
Nedlands, WA 6009
Australia
Country
Australia
Secondary sponsor category [1] 297027 0
None
Name [1] 297027 0
Address [1] 297027 0
Country [1] 297027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299005 0
The Western Australian Aboriginal Health Ethics Committee (WAAHEC)
Ethics committee address [1] 299005 0
Ethics committee country [1] 299005 0
Australia
Date submitted for ethics approval [1] 299005 0
18/10/2015
Approval date [1] 299005 0
19/05/2017
Ethics approval number [1] 299005 0
677

Summary
Brief summary
DMO is the most common cause of visual loss in people with diabetes. Regular injections with bevacizumab (Avastin), given as frequently as every month, remain the current standard of care for centre-involving DMO, but this regimen is impractical for many Indigenous patients. Limiting injections to 3-6 monthly with Ozurdex may be as effective as the currently used Avastin injections.

The specific aim of the study is therefore to test the following hypothesis:
1. Ozurdex® is a safe and non-inferior treatment to Avastin® when administered during or following cataract surgery in Indigenous patients with/at risk of DMO.
2. Ozurdex ® requires fewer injections when compared with Avastin® in Indigenous patients with/at risk of DMO.
Trial website
Trial related presentations / publications
Public notes
Conditional Approval from WAAHEC was granted on 24/11/2015, with Final Approval granted on 19/05/2017. The small number of participants enrolled within this time period were subsequently disqualified and withdrawn from the trial, Participant enrolment recommenced July 2017.

Contacts
Principal investigator
Name 78970 0
Dr Hessom Razavi
Address 78970 0
Lions Eye Institute
Retinal Pod
2 Verdun St
Nedlands WA 6009
Country 78970 0
Australia
Phone 78970 0
+61 8 6382 0544
Fax 78970 0
+61 8 9381 0700
Email 78970 0
hessomrazavi@lei.org.au
Contact person for public queries
Name 78971 0
Ms Sarah Oldfield
Address 78971 0
Lions Outback Vision
2 Verdun Street
Nedlands WA 6009
Country 78971 0
Australia
Phone 78971 0
+61 8 9381 0802
Fax 78971 0
+61 8 9381 0700
Email 78971 0
SarahOldfield@lei.org.au
Contact person for scientific queries
Name 78972 0
Dr Hessom Razavi
Address 78972 0
Lions Outback Vision
2 Verdun Street
Nedlands WA 6009
Country 78972 0
Australia
Phone 78972 0
+61 8 6382 0544
Fax 78972 0
+61 8 9381 0700
Email 78972 0
HessomRazavi@lei.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect individual patient confidentiality.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
Not applicable