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Trial registered on ANZCTR


Registration number
ACTRN12615000118505
Ethics application status
Approved
Date submitted
28/01/2015
Date registered
10/02/2015
Date last updated
30/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Is it possible to use long acting steroid preparations such as the dexamethasone intravitreal implant Ozurdex to prevent a deterioration in vision in patients with diabetes undergoing cataract surgery in central Australia.
Scientific title
Intra-operative administration of dexamethasone intravitreal implants (Ozurdex) versus intravitreal Bevacizumab during cataract surgery for improving visual outcomes in the management of diabetic maculopathy in Central Australia.
Secondary ID [1] 285997 0
Nil known
Universal Trial Number (UTN)
U1111-1166-2630
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic retinopathy 293955 0
Diabetic macular edema 293956 0
Cataract 293957 0
Condition category
Condition code
Eye 294253 294253 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 294254 294254 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.7mg intravitreal dexamethasone implant (Ozurdex) administered during cataract surgery. Followup will be offered monthly, with Ozurdex retreatment up to 4 monthly as clinically indicated. The overall intervention period for this trial will be 12 months. The implant does not need to be removed (it dissolves over time).
Intervention code [1] 290975 0
Treatment: Drugs
Comparator / control treatment
1.25mg/0.5ml intravitreal Bevacizumab administered during cataract surgery. Followup will be offered monthly, with Bevacizumab retreatment up to monthly as clinically indicated. The overall intervention period for this trial will be 12 months.
Control group
Active

Outcomes
Primary outcome [1] 294052 0
Best corrected visual acuity measured with a "Rolling E chart".
Timepoint [1] 294052 0
6 months and 1 year
Secondary outcome [1] 312427 0
Change in central retinal thickness using Optical Coherence tomography (OCT)
Timepoint [1] 312427 0
6 months and 1 year
Secondary outcome [2] 312428 0
Number of intravitreal injections required post-operatively
Timepoint [2] 312428 0
1 year
Secondary outcome [3] 312429 0
Laser treatment required post-operatively (Yes/no)
Timepoint [3] 312429 0
1 year
Secondary outcome [4] 312430 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 required. Development of cataract will not be of concern in this study as the implant will be administered at the time of, and subsequent to cataract surgery.
Timepoint [4] 312430 0
1 year

Eligibility
Key inclusion criteria
- Adult patients treated by the Central Australian & Barkly Integrated Eye Health Service, who fit either of the following 2 treatment groups:
A. Patients with active DME (defined as macular involving DR, with retinal thickening as assessed on clinical examination), or
B. Patients with diabetic retinopathy without active DME
- Participants must have significant lens opacity (more than grade 3 for any type of cataract) and scheduled to undergo cataract surgery at the time of enrolment into the study.
- Participants must have reduced vision (BCVA impaired to at least the level of (6/9)) in the eye included for the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior intervention in the affected eye, including intravitreal anti-VEGF injections within the last 6 weeks, laser within the last 3 months, or Intravitreal triamcinolone within the last 6 months of time of surgery.
- History of open-angle glaucoma or steroid induced IOP elevation that required IOP-lowering treatment, or, IOP greater than or equal to 25.
- Eyes with concurrent ocular pathology other than DME causing visual loss.
- Patients under the age of 18.

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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / 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)
NT,SA
Recruitment hospital [1] 3347 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [2] 3348 0
Flinders Medical Centre - Bedford Park

Funding & Sponsors
Funding source category [1] 290589 0
Commercial sector/Industry
Name [1] 290589 0
ALLERGAN AUSTRALIA PTY. LTD
Address [1] 290589 0
Level 4
810 Pacific Highway
Gordon, NSW 2072
Australia
Country [1] 290589 0
Australia
Primary sponsor type
Hospital
Name
Alice Springs Hospital
Address
Gap Rd
Alice Springs
NT 0870
Country
Australia
Secondary sponsor category [1] 289280 0
None
Name [1] 289280 0
Address [1] 289280 0
Country [1] 289280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292227 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 292227 0
Centre for Remote Health
PO BOX 4066
Alice Springs
NT 0871
Ethics committee country [1] 292227 0
Australia
Date submitted for ethics approval [1] 292227 0
31/01/2015
Approval date [1] 292227 0
15/04/2015
Ethics approval number [1] 292227 0
HREC-15-286
Ethics committee name [2] 294186 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [2] 294186 0
Flinders Medical Centre
The Flats G5 - Rm 3 and 4
Flinders drive,
Bedford park
SA 5042
Ethics committee country [2] 294186 0
Australia
Date submitted for ethics approval [2] 294186 0
29/05/2015
Approval date [2] 294186 0
06/08/2015
Ethics approval number [2] 294186 0
253.15

Summary
Brief summary
Diabetic macular edema (DME) is the most common cause of visual loss in people with diabetes. Regular injections with the anti-VEGF agent Bevacizumab remain the current standard of care for DME involving the fovea, but this regimen is impractical in central Australia. Limiting injections to 4 monthly with Ozurdex may be as effective as the currently used Bevacizumab injections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54194 0
Dr Stewart Lake
Address 54194 0
Department of Ophthalmology, Flinders University
GPO Box 2100,
Adelaide, SA, 5001
Country 54194 0
Australia
Phone 54194 0
+61 08 8204 4899
Fax 54194 0
Email 54194 0
stewart.lake@health.sa.gov.au
Contact person for public queries
Name 54195 0
Dr Georgia Kaidonis
Address 54195 0
Department of Ophthalmology, Flinders University
GPO Box 2100,
Adelaide, SA, 5001
Country 54195 0
Australia
Phone 54195 0
+61 08 8204 6985
Fax 54195 0
Email 54195 0
georgia.kaidonis@flinders.edu.au
Contact person for scientific queries
Name 54196 0
Dr Georgia Kaidonis
Address 54196 0
Department of Ophthalmology, Flinders University
GPO Box 2100,
Adelaide, SA, 5001
Country 54196 0
Australia
Phone 54196 0
+61 08 8204 6985
Fax 54196 0
Email 54196 0
georgia.kaidonis@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
No Results