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Trial registered on ANZCTR


Registration number
ACTRN12611000300976
Ethics application status
Approved
Date submitted
15/03/2011
Date registered
22/03/2011
Date last updated
22/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bevacizumab intravitreal injection in the treatment of patients with Central Retinal Vein Occlusion.
Scientific title
A 12 month, phase 2, single-centre, masked, randomised, sham-controlled trial to assess the safety and efficacy of a 1.25mg/0.05ml Bevacizumab intravitreal injection in the treatment of patients with Central Retinal Vein Occlusion (CRVO).
Secondary ID [1] 259786 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central retinal vein occlusion (CRVO) 261368 0
Condition category
Condition code
Eye 259526 259526 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient will receive an intravitreal injection at baseline, week 4 and week 8.
Repeat injections will be decided on an as needed basis
The dosage for Bevacizumab is 1.25mg/0.05ml administered via a intravitreal injection into the eye.The procedure will take 5 minutes in total.
Intervention code [1] 264219 0
Treatment: Drugs
Comparator / control treatment
Sham control Injection
Site determined using calliper at 3.5-4mm posterior to corneal limbus and then pressure on the eye to simulate an injection (sham injection).
Injection site tamponaded with sterile cotton bud for 5 seconds.
The patient will receive a sham injection at baseline, week 4 and week 8. The procedure will take 5 minutes in total.
Control group
Placebo

Outcomes
Primary outcome [1] 262332 0
BCVA (best corrected visual acuity) logMAR
Timepoint [1] 262332 0
Baseline then monthly for 12 months
Secondary outcome [1] 273556 0
1 Central retinal thickness.Measured using Ocular Coherance Tomography and clinical assessment.
Timepoint [1] 273556 0
Baseline then monthly for 12 months
Secondary outcome [2] 273557 0
2 Neovascular complications.This assessment will be made using FFA(Fundus Fluoroscein Angiogram) and slit lamp/clinical observation.
Timepoint [2] 273557 0
Baseline then monthly for 12 months
Secondary outcome [3] 273558 0
3 Drug related adverse effects
There is a theoretical increased risk of strokes with anti-Vascular Endothelial Growth Factor(anti-VEGF), however the actual risk of stroke with anti-VEGF is unknown.
Ranibizumab (Lucentis) a commonly used anti-VEGF agent results in a severe inflammation of eye (uveitis) in less that 1 in 500 cases. Though not reported in bevacizumab it could be a potential side effect.
This assessement will be made by clinical observation and assessment and documentation.
Timepoint [3] 273558 0
Baseline then monthly for 12 months
Secondary outcome [4] 273559 0
4 Complications related to intravitreal injection.
These include Endophthalmitis (infection of the eye): symptoms include burning sensation, eye pain, increased blurring of vision, light sensitivity and redness. Studies have shown that the chance of getting an infection is 0.1 per cent and this is why antibiotics are given prior and following treatment.
Elevated Eye Pressure: this is usually temporary and due to an increase of fluid entering the eye.
Retinal Detachment, Bleeding and Cataract Formation: these are unusual complications occurring in less than 1 per cent of patients in trial studies.
This assessement will be made by clinical observation and assessment and documentation.
Timepoint [4] 273559 0
Baseline then monthly for 12 months

Eligibility
Key inclusion criteria
Age>18 years,
Males and females,
Patients presenting with macular oedema secondary to CRVO.
BCVA of 20/40 to 20/320 in the study eye
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects that have used other investigational drug for last 30 days or 5 half-lives (whichever is longer)
Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance greater than or equal to 50 mL/minute)
Diabetic retinopathy with clinically significant macular oedema.
Retreatment in therapy associated with severe vision loss; unstable heart disease, uncontrolled hypertension; pregnancy, lactation, children
History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery,
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etcetera),
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure equal to 25 mmHg despite treatment with anti-glaucoma medication),
Aphakia with absence of the posterior capsule in the study eye,
Active intraocular inflammation (grade trace or above) in the study eye,
Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye,
Vitreous hemorrhage precluding evaluation of the eye or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
Presence of a retinal pigment epithelial tear involving the macula in the study eye, Subfoveal fibrosis or significant atrophy in the study eye
Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
Known sensitivity to study drug(s) or class of study drug(s)
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)

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)
The patient will receive an intravitreal injection at baseline, week 4 and week 8.
Repeat injections will be decided on PRN basis.
The patients will be followed up at 4 weekly intervals for a period of 12 months. BCVA by logMAR and CRT will be recorded at each visit and FFA repeated at 12 weeks intervals
Randomized by sequenced opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation)
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
23/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264665 0
Hospital
Name [1] 264665 0
Royal Adelaide Hospital
Country [1] 264665 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Ophthalmology Network
Level 8,East Wing
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 263803 0
None
Name [1] 263803 0
Address [1] 263803 0
Country [1] 263803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266661 0
Rpyal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 266661 0
Ethics committee country [1] 266661 0
Australia
Date submitted for ethics approval [1] 266661 0
01/02/2009
Approval date [1] 266661 0
23/02/2009
Ethics approval number [1] 266661 0
081119

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32345 0
Address 32345 0
Country 32345 0
Phone 32345 0
Fax 32345 0
Email 32345 0
Contact person for public queries
Name 15592 0
Associate Professor Robert Casson MBBS Dphil FRANZCO
Address 15592 0
Director of Ophthalmic Research
Royal Adelaide Hospital
East Wing, Level 8
North Terrace
Adelaide
SA 5000
Country 15592 0
Australia
Phone 15592 0
+61 8 8222 2732
Fax 15592 0
+61 8 8222 2741
Email 15592 0
[email protected]
Contact person for scientific queries
Name 6520 0
Associate Professor Robert Casson MBBS Dphil FRANZCO
Address 6520 0
Director of Ophthalmic Research
Royal Adelaide Hospital
East Wing, Level 8
North Terrace
Adelaide
SA 5000
Country 6520 0
Australia
Phone 6520 0
+61 8 8222 2732
Fax 6520 0
+61 8 8222 2741
Email 6520 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

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