Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000091909
Ethics application status
Approved
Date submitted
1/06/2010
Date registered
25/01/2011
Date last updated
25/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase 2, twelve month, randomized, controlled trial of combined
treatment for exudative age related macular degeneration with variable
dosing Ranibizumab (Lucentis) and Sub-Tenon Triamcinolone (Kenacort-A 40).
Scientific title
The effect of variable dosing Ranibizumab (Lucentis) and Sub-Tenon Triamcinolone (Kenacort-A 40) on visual acuity and number of intravitreal injections in patients with exudative age related macular degeneration.
Secondary ID [1] 251918 0
None
Universal Trial Number (UTN)
Trial acronym
TART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
exudative age related macular degeneration 257500 0
Condition category
Condition code
Eye 257655 257655 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
treatment regimen of variable-dosing ranibizumab and regular subtenons triamcinalone (STTA)
The treatment adminstered is Ranibizumab (Lucentis) intravitreal injection, 0.5 mg/0.5 ml administered monthly for 3 months then monthly as required judged by the medical officer for up to 12 months.
Subtenons Triamcinalone injection(Kenacort-A 40) 40 mg/1 ml will be administered immediately after the first dose of Ranibizumab,then not more than 4 monthly as required there after, for up to 12 months as judged by the medical officer.
Intervention code [1] 256594 0
Treatment: Drugs
Comparator / control treatment
All patients will be treated with intravitreal Ranibizumab injection (Lucentis) 0.5mg/0.05ml each month for 3 months.
At baseline all subjects will be randomised to receive subtenons triamcinalone 40mg/1ml or a sham subtenons injection of normal saline at time of diagnosis, immediately following Ranibizumab injection,on a 4 monthly as required, basis thereafter.
Control group
Placebo

Outcomes
Primary outcome [1] 258563 0
One primary outcome measures are visual acuity at 12 months assessed by using Log Mar for best corrected visual accuity
Timepoint [1] 258563 0
Initial baseline measurement followed by monthly follow up assessments for a twelve month period in total.
Primary outcome [2] 258564 0
number of intravitreal injections required assessed in medical records and trial source notes
Timepoint [2] 258564 0
Monthly follow up for a twelve month period in total.
Secondary outcome [1] 264422 0
Nil
Timepoint [1] 264422 0
Nil

Eligibility
Key inclusion criteria
Age 50 years or older.
Active primary or recurrent subfoveal choroidal neovascularization secondary to Age Related Macular Degeneration (ARMD).
Occular Coherence Tomography(OCT) central retinal thickness greater than 300 microns.
Best-corrected visual acuity (BCVA) of 20/40 to 20/400 (Snellen equivalent) in the study eye.
Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute)
In patients with bilateral presentation of exudative ARMD the eye of most recent onset will be enrolled.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous subfoveal focal laser photocoagulation in the study eye.
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding day 0 (day of first injection).
Subfoveal fibrosis or atrophy in the study eye.
History of vitrectomy surgery in the study eye.
Aphakia or absence of the posterior capsule in the study eye.
History of idiopathic or autoimmune-associated uveitis (intraocular inflammation) in either eye.
Pregnancy. Sexually active pre-menopausal women will be required to have a serum Beta-Human chorionic gonadotropin (Beta-HCG) pregnancy test prior to each injection.
Uncontrolled glaucoma (defined as intraocular pressure >25 mmHg despite treatment with antiglaucoma medication).
Loss of vision due to other causes,
Systemic treatment with greater than or equal to 5 mg prednisolone (or equivalent) daily.
Intercurrent severe systemic disease.
Any condition affecting follow-up or documentation.
Active ocular, periocular or systemic infection.
Idiopathic thrombocytopaenic purpura.
Hypersensitivity to either Ranibizumab or Triamcinalone.
Known severe steroid responder.
Presence of a scleral buckle from previous retinal detachment surgery

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)
Patients with newly diagnosed exudative ARMD will be recruited at time of diagnosis by the treating ophthalmologist at the Royal Adelaide Hospital, Flinders Medical Centre, The Queen Elizabeth Hospital and Lyell McEwin Hospital.
Subjects will be randomized in order of review and consent.The randomization numbers are concealed in opaque, numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization occurs off site via a computer program. This is done by non-clinical administrator. The numbers are then concealed in opaque envelopes and numbered 1 to 44.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257088 0
Hospital
Name [1] 257088 0
Royal Adelaide Hospital
Country [1] 257088 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Ophthalmology Network
Lev 8, EW
North Tce
ADELAIDE SA 5000
Country
Australia
Secondary sponsor category [1] 256345 0
Charities/Societies/Foundations
Name [1] 256345 0
The Eye Foundation
Address [1] 256345 0
94-98 Chalmers Street , Surry Hills, NSW 2010
Country [1] 256345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259114 0
Royal Adelaide Hospital
Ethics committee address [1] 259114 0
Lev 3 Hanson Institute
Institute Medical and Vetinary Services (IMVS)
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Ethics committee country [1] 259114 0
Australia
Date submitted for ethics approval [1] 259114 0
Approval date [1] 259114 0
04/11/2009
Ethics approval number [1] 259114 0
091021

Summary
Brief summary
The purpose of this study is to evaluate a treatment regimen of variable-dosing ranibizumab and regular subtenons triamcinalone (STTA) for exudative age related macular degeneration. Our aim is to reduce the number of intravitreal injections required with the same or better visual outcome as currently accepted treatment regimens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31247 0
Address 31247 0
Country 31247 0
Phone 31247 0
Fax 31247 0
Email 31247 0
Contact person for public queries
Name 14494 0
Kylie Dansie
Address 14494 0
South Australian Institute of Ophthalmology
Royal Adelaide Hospital
Lev 8 EW
North Tce ADELAIDE SA 5000
Country 14494 0
Australia
Phone 14494 0
+61 8 8222 2732
Fax 14494 0
+61 8 8222 2741
Email 14494 0
[email protected]
Contact person for scientific queries
Name 5422 0
Tim Gray
Address 5422 0
South Australian Institute of Ophthalmology
Royal Adelaide Hospital
Lev 8 EW
North Tce ADELAIDE SA 5000
Country 5422 0
Australia
Phone 5422 0
+61 (0)412500961
Fax 5422 0
+61 8 8222 2741
Email 5422 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.