Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000262404
Ethics application status
Approved
Date submitted
10/05/2007
Date registered
16/05/2007
Date last updated
9/01/2020
Date data sharing statement initially provided
9/01/2020
Date results information initially provided
9/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy and Safety of Treatment with Intravitreal Ranibizumab in Patients with Branch Retinal Vein Occlusion.
Scientific title
The Efficacy and Safety of Treatment with Intravitreal Ranibizumab in Patients with Branch Retinal Vein Occlusion.
Secondary ID [1] 286105 0
Nil
Universal Trial Number (UTN)
Trial acronym
L-BRVO Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macula oedema secondary to Branch Retinal Vein Occlusion. 1801 0
Condition category
Condition code
Eye 1888 1888 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have macula oedema secondary to Branch Retinal Vein Occlusion (BRVO), patients who meet all the eligibilty criteria and who sign a Patient Information and Consent Form, will be randomsied to receive 0.5mg Ranibizumab (Lucentis) or placebo as an intravitreal injection into the study eye monthly for 6 months. After 6 months, patients will be evaluated and may receive further intravitreal injections, if they are required (up to 6 injections). All patients will be evaluated by a masked investigator at 3 and 6 months for laser grid treatment, this is the standard treatment for this condition.
Intervention code [1] 1744 0
Treatment: Drugs
Comparator / control treatment
Patients assigned to received placebo injections will have their study eye prepared for an intravitreal injection, but an empty syringe hub will be placed on the eye. Nothing will be injected into the eye.
Control group
Placebo

Outcomes
Primary outcome [1] 2685 0
The primary objective will be the proportion of eyes showing an improvement in visual acuity by 10 letters on the LogMar chart for the treatment versus the sham group
Timepoint [1] 2685 0
Assessed at baseline and at 52 weeks.
Secondary outcome [1] 4543 0
The secondary outcome will be the change in baseline OCT (Optical Coherence Tomography) central macular thickness between the treatment versus the sham group.
Timepoint [1] 4543 0
At 52 weeks.

Eligibility
Key inclusion criteria
1. Macular oedema in the study eye with the following characteristics:a. Due to BRVO.b. Involving the centre of the fovea.c. Duration 6 week to 9 months prior to baseline visit.d. Visual acuity reduction attributable to the oedema where the macula is non-ischaemic (<50% ischaemic injury to the perifoveolae vascular zone).2. Best corrected visual acuity (BCVA) score as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at baseline between 20 letters and 68 letters (approximately 20/50 to 20/400 Snellen visual acuity). 3. Central macular oedema as measured by OCT at baseline to exceed 250 um. 4. Clear ocular media and adequate pupillary dilation.5. Written informed consent.6. Ability to return for all study visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding.2. Known sensitivity to study drug(s) or class of study drug(s).3. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required). 4. Use of any other investigational agent in the last 30 days.5. Any other ocular condition in the study eye that would prevent improvement in visual acuity, e.g., macular ischaemia, underlying macular degeneration, epi-retinal membrane.6. Neovascularisation of the iris, disc or retina.7. Previous treatment with intravitreal corticosteriods, intravitreal anti-VEGF agents or macular grid laser in previous 3 months.8. Aphakia or presence of anterior chamber lens in the study eye.9. Significant media opacities such as cataract.10. Previous pars plana vitrectomy.11. History of retinal detachment or surgery for retinal detachment.12. Any condition which would preclude a patient's ability to comply with the study requirements or to be available for the duration of the study.13. BRVOs that have more than 10-disc diamteres of capillary non perfusion.14. Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, sclertitis, endoophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye.15. Presence of a retinal pigment epithelial tear involving the macula in the study eye.16. Any evidence of significant AMD in the study eye.17. Extra capsular extraction of cataract with phacoemulsification within 3 months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis etc).18. Contra indication to pupil dilation in either eye.

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 that are referred to the study centres will be evaluated by the site investigator to determine eligibility for the study. If the patient meets the study criteria, then the study will be explained to the patient, and the patient will be given a Patient Information and Consent Form to read and bring to the screening visit. At the screening visit, all questions about the study will be answered and the Patient Information Consent Form is signed. The screening procedures and tests are performed. Each patient will be randomised to receive the study treatment (0.5mg Ranibizumab) or placebo using a series of serially numbered, opaque envelopes containing as assignment to treatment or placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment assignments are compiled using a list of computer generated pseudo-random numbers in permuted blocks of variable size. Patients are randomised for treatment in one eye only. Sealed envelopes containing the randomisation are sent to each site from the co-ordinating centre. The envelopes contain the patient number and are opened sequentially.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Those blinded in the study include: 1. The patients. 2. The Visual Acuity Examiners who collect the data for the primary outcome objectives of the study. 3. The masked investigators who assess the patients at Weeks 13 and 25 to determine whether grid laser treatment is required.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/05/2007
Actual
26/07/2007
Date of last participant enrolment
Anticipated
Actual
13/01/2011
Date of last data collection
Anticipated
Actual
8/02/2012
Sample size
Target
40
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2036 0
Commercial sector/Industry
Name [1] 2036 0
Novartis Pharmaceuticals Australia Pty Ltd
Country [1] 2036 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Ian McAllister
Address
Lions Eye Institute
2 Verdun St
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 1844 0
None
Name [1] 1844 0
Nil
Address [1] 1844 0
Country [1] 1844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3768 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 3768 0
First Floor, E Block, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6009.
Ethics committee country [1] 3768 0
Australia
Date submitted for ethics approval [1] 3768 0
Approval date [1] 3768 0
28/03/2007
Ethics approval number [1] 3768 0
2006-148
Ethics committee name [2] 3769 0
Royal Victorian Eye and Ear Hospital Human Research & Ethics Committee.
Ethics committee address [2] 3769 0
32 Gisborne St, East Melbourne, Victoria, 3002.
Ethics committee country [2] 3769 0
Australia
Date submitted for ethics approval [2] 3769 0
Approval date [2] 3769 0
22/03/2007
Ethics approval number [2] 3769 0
07/729H,
Ethics committee name [3] 3770 0
South Eastern Sydney and illawarra Area Health Service Human Research Ethics.
Ethics committee address [3] 3770 0
RM G71, Edmund Blacket Building. POW Campus, Randwick, NSW.
Ethics committee country [3] 3770 0
Australia
Date submitted for ethics approval [3] 3770 0
Approval date [3] 3770 0
04/07/2007
Ethics approval number [3] 3770 0

Summary
Brief summary
This is a phase II randomised, single, dose, masked, multicentre trial to determine the efficacy of 0.5mg Ranibizumab intravitreal injections in the treatment of macular oedema secondary to BRVO over one year compared with standard laser grid. Patients eligible for the study will be randomised to receive an intravitreal injection of 0.5mg Ranibizumab or placebo for 6 months. Patients will be monitored for a further 6 months to see whether further treatment is required. Patients are evaluated by a masked investigator at 3 and 6 months to determine whether they require laser grid, the current standard treatment for this condition. The primary outcome will be the proportion of eyes showing an improvement of visual acuity by 10 letters on the LogMar chart for the treatment group versus the sham group at 52 weeks compared with baseline. The secondary outcome will be the change in baseline OCT central macular thickness between the treatment and the sham groups at 52 weeks. The tertiary objective will be the change in the mean capillary non-perfusion between the sham/laser and treatment groups at 52 weeks and the number of patients requiring grid macular laser.
Trial website
Trial related presentations / publications
Randomized Controlled Trial of Intravitreal Ranibizumab versus Standard Grid Laser for Macular Edema Following Branch Retinal Vein Occlusion. M.H.Tan, I.L.McAllister, M.E.Gillies, N.Verma, G.Banerjee, L.A.Smithies, W-L Wong and T.Y.Wong (2014) American Journal of Ophthalmology 157:237-247.
Public notes

Contacts
Principal investigator
Name 27847 0
Prof Ian McAllister
Address 27847 0
Lions Eye Institute
2 Verdun St
Nedlands
WA
6009
Country 27847 0
Australia
Phone 27847 0
+61 8 9381 0870
Fax 27847 0
Email 27847 0
[email protected]
Contact person for public queries
Name 10933 0
Prof Prof Ian McAllister
Address 10933 0
Lions Eye Institute
2 Verdun St
Nedlands WA 6009
Country 10933 0
Australia
Phone 10933 0
+61 8 93810870
Fax 10933 0
+61 8 93810766
Email 10933 0
[email protected]
Contact person for scientific queries
Name 1861 0
Prof Prof Ian McAllister
Address 1861 0
Lions Eye Institute
2 Verdun St
Nedlands WA 6009
Country 1861 0
Australia
Phone 1861 0
+61 8 93810870
Fax 1861 0
+61 8 93810766
Email 1861 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.