Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000063910
Ethics application status
Approved
Date submitted
2/06/2010
Date registered
18/01/2011
Date last updated
18/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II, 12 month, randomized, sham-controlled trial of ranibizumab (Lucentis) combined with grid laser compared
with laser alone for the treatment of recalcitrant, diabetic
macular oedema.
Scientific title
The effect of Ranibizumab (Lucentis) combined with grid laser compared with laser alone on vision in patients with recalcitrant, diabetic macular oedema
Secondary ID [1] 253438 0
Nil
Universal Trial Number (UTN)
Trial acronym
DMO Rescue Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 257507 0
Diabetic Retinopathy 258863 0
Condition category
Condition code
Eye 257667 257667 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 259000 259000 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ranibizumab (Lucentis) combined with grid laser compared
with laser alone for the treatment of recalcitrant, diabetic
macular oedema.
Ranibizumab(Lucentis)will be administered via intravitreal injection on at least 3 occasions. There will possibly be as many as 9 injections in a 12 month period.
Injection dose is 0.05 ml/1.25 mg once/day.The initial 3 injections will be given at 1 month intervals and subsequent injections will be given at the discretion of the attending medical officer at 6 week intervals.The injection procedure will take approximately 5 minutes.
Intervention code [1] 257790 0
Treatment: Drugs
Intervention code [2] 257882 0
Treatment: Devices
Comparator / control treatment
Type of Laser is Alcon Ophthalas 532 with 100 micrometre spot size,80-150MW power,0.1 second duration.Each laser session duration is 15 minutes.
Grid laser will be administered once at week 2 of the study for all participants.In the treatment group discretionary focal laser will be administered at week 14 and 32.
The sham group will receive as needed grid laser at week 14 and 32.The sham group will receive placebo injection procedure by having pressure applied on the eye to simulate an injection (sham injection). Injection site is then tamponaded with sterile cotton bud for 5 seconds.
Control group
Active

Outcomes
Primary outcome [1] 258571 0
Primary objective: Improve the vision of patients with diabetic macular oedema (DMO) affecting the centre of the fovea that has persisted despite laser treatment.Outcomes will be assessed via Best Corrected Visual Acuity testing(BCVA),Central Retinal Thickness,Intraocular pressure and eye examination from medical officer.
Timepoint [1] 258571 0
Following first visit at baseline, there are 2 weekly visits until week 10, another visit scheduled for week 14 then 6 weekly visits until the completion and review of DMO for a 12 month period.
Secondary outcome [1] 264434 0
Secondary objective: Reduce retinal thickness as measured by OCT (optical coherence tomography).
Timepoint [1] 264434 0
OCT will be performed at first visit at baseline, then 2 weekly until week 10, week 14, then 6 weekly until the completion and review of DMO for a 12 month period.

Eligibility
Key inclusion criteria
I. Age 18 years or older.
I. Diabetic macula oedema involving the fovea.
II. OCT central retinal thickness greater than 250 microns or paracentral macular thickness greater than 300um.
III. Best-corrected visual acuity (BCVA) of 0.3 to 1.90 logMAR (6/12-6/477 Snellen equivalent) in the study eye.
IV. At least one full grid or 2 focal laser treatments to DMO no sooner than 4 months prior to randomisation.
V. Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
I. Macular ischaemia on Fundus Fluroscein Angiogram(FFA)
II. Untreated retinal or iris neovascularization.
III. Subfoveal fibrosis or atrophy in the study eye.
IV. History of vitrectomy surgery in the study eye.
V. History of idiopathic or autoimmune-associated uveitis in either eye.
VI. Pregnancy, breastfeeding or inadequate birth control in premenopausal females. All patients of child-bearing potential will be required to have a urinary pregnancy test at the screening visit and if sexually active, prior to each intravitreal ranibizumab injection.
VII. Loss of vision due to other causes,
VIII. Intercurrent severe systemic disease.
IX. Any condition affecting follow-up or documentation.
X. Active ocular, periocular or systemic infection.
XI. Idiopathic thrombocytopaenic purpura.
XII. Hypersensitivity to ranibizumab.
XIII. Previous treatment with anti-vascular endothelial growth factor(VEGF) agents within 6 weeks of enrolment.
XIV. Triamcinolone intravitreal or subtenon injection within 4 months prior to randomisation.
XV. Past known history of stroke or myocardial infarction.

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 recalcitrant diabetic macular oedema involving the centre of the fovea will be recruited by the treating ophthalmologist at the Royal Adelaide Hospital, The Queen Elizabeth Hospital and Lyell McEwin Hospital. 40 patients in total will be recruited and randomised. 20 will receive ranibizumab, 20 will be in the sham arm.Treatment will be concealed in numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomized in number sequence according to date of review and consent. Treatment will be consealed in the number opque envelopes. These treatments will be randomized off site by an administrator using a computer randomized program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/04/2010
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] 257097 0
Commercial sector/Industry
Name [1] 257097 0
Novartis
Country [1] 257097 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Novartis Pharmaceuticals Australia Pty Ltd
54 Waterloo Rd
North Ryde
NSW 2113
Country
Australia
Secondary sponsor category [1] 256354 0
None
Name [1] 256354 0
Address [1] 256354 0
Country [1] 256354 0
Other collaborator category [1] 1313 0
Hospital
Name [1] 1313 0
Royal Adelaide Hospital
Address [1] 1313 0
Ophthalmology Network
Lev 8 East Wing
North Tce
ADELAIDE SA 5000
Country [1] 1313 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259130 0
Royal Adelaide Ethics Committee
Ethics committee address [1] 259130 0
Hanson Institute Level 3
Institute of Medical and Vetinary Science(IMVS)
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Ethics committee country [1] 259130 0
Australia
Date submitted for ethics approval [1] 259130 0
Approval date [1] 259130 0
07/12/2009
Ethics approval number [1] 259130 0
090930

Summary
Brief summary
Objectives:
Primary objective: Improve the vision of patients with diabetic macular oedema (DMO) affecting the centre of the fovea that has persisted despite laser treatment.

Secondary objective: Reduce retinal thickness as measured by OCT (optical coherence tomography).


Strategic goal:
Primary Objective:
1. To determine if combined treatment with ranibizumab and grid laser for recalcitrant diabetic maculopathy is more effective in improving visual acuity than grid laser alone.

Secondary Objectives:
1. To design a treatment protocol that requires less visits and intravitreal injections than similar studies currently in progress. This would be more acceptable to patients and clinicians.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31252 0
Address 31252 0
Country 31252 0
Phone 31252 0
Fax 31252 0
Email 31252 0
Contact person for public queries
Name 14499 0
Kylie Dansie
Address 14499 0
South Australian Institute of Ophthalmology
Lev 8 East Wing
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country 14499 0
Australia
Phone 14499 0
+61 8 8222 2732
Fax 14499 0
+61 8 8222 2741
Email 14499 0
kylie.dansie@health.sa.gov.au
Contact person for scientific queries
Name 5427 0
Mr Grant Raymond
Address 5427 0
South Australian Institute of Ophthalmology
Lev 8 East Wing
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country 5427 0
Australia
Phone 5427 0
+61(0)412667906
Fax 5427 0
+61(0)8 8222 2741
Email 5427 0
graymond@internode.on.net

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
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