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Trial registered on ANZCTR


Registration number
ACTRN12607000315415
Ethics application status
Approved
Date submitted
7/06/2007
Date registered
13/06/2007
Date last updated
13/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Avastin in the treament of Macular oedema and Uveitis
Scientific title
Prospective, Phase II , non-randomised interventional case series of the safety and efficacy of the use of intra-vitreal bevacizumab ("Avastin") in the treatment of macular oedema secondary to diabetic retinopathy and uveitis, and for choroidal neovascular membranes secondary to uveitis, with respect to visual acuity and central macular thickness
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
1. Macular oedema secondary to diabetic retinopathy
 1859 0
2. Macular oedema secondary to uveitis
 1860 0
3. Subfoveal choroidal neovascularisation (CNV) secondary to uveitis 1861 0
Condition category
Condition code
Eye 1953 1953 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 1954 1954 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravitreal injection of bevacizumab (1.25mg in 0.05ml) every six weeks as required. Visual acuity and central macular thickness will be compared against these measurements that were taken at baseline (ie. no controls).

Repeat injections will be performed in those with macular oedema if there is:
a) Persistence, relapse or increase of macular oedema involving the centre, or central macular thickness, demonstrated by examination and OCT
OR
b) A decline of best corrected visual acuity of 5 letters (Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity) below the best visual acuity after treatment

Repeat injections will be performed in those with uveitic CNV if there is:
a) A decline of best corrected visual acuity of 5 letters (ETDRS LogMAR) below the best VA after treatment, OR
b) An increase in OCT central retinal thickness of at least 100µm from the lowest thickness reading, OR
c) New macular haemorrhage, OR
d) New area of classic CNV, OR
e) Evidence of persistent fluid on OCT at least one month after the previous injection

Injections will be ceased if:
1. There is no improvement in either the visual acuity or central macular thickness after 3 injections in comparison to baseline measurements (i.e. Treatment failure), OR
2. Central macular thickness < 220 microns with no evidence of subretinal or intraretinal oedema as measured and assessed on Optical Coherence Tomography (OCT), OR
3. Best corected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity is better than or equal to 6/6

The last 2 criteria listed above would be considered as a complete treatment response.
Intervention code [1] 1813 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2772 0
Best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual acuity
Timepoint [1] 2772 0
At baseline and at 3 and 12 months after intervention commencement
Secondary outcome [1] 4667 0
Central Macular thickness as measured on Optical Coherence Tomography
Timepoint [1] 4667 0
At baseline and at 3 and 12 months after intervention commencement

Eligibility
Key inclusion criteria
Clinically significant macular oedema secondary to diabetes involving the fovea in one or both eyes that has been refractory to previous standard treatments (e.g. laser) where local steroid therapy is contraindicated (e.g. pre-existing glaucoma or steroid responder) or ineffective, OR3. Uveitic cystoid macular oedema in one or both eyes that has either been unresponsive to standard treatment (including intravitreal triamcinolone) or where further local steroid treatment is relatively contraindicated (e.g. pre-existing glaucoma or steroid responder) or ineffective, OR4. Subfoveal or juxtafoveal choroidal neovascularisation (CNV) secondary to uveitis in one or both eyesBest corrected visual acuity in the affected eye(s) = 6/12 or worse5. Subjects must have signed the informed consent form.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Loss of vision due to other causes (e.g. myopic macular degeneration)2. Surgical intervention in the study eye within 2 months preceding recruitment3. Significant macular ischaemia4. No useful vision in fellow eye5. Known allergies to bevacizumab or ranubizumab6. Active ocular infection (eg. Conjunctivitis, keratitis)7. Intercurrent severe disease such as septicaemia8. History of other systemic disease(s) that, in the opinion of the investigator, may render the subject at a high risk for treatment complications9. Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities) 10. Unwillingness or inability to give informed consent11. Under age 1812. Pregnant or lactating women13. Premenopausal women of child bearing potential not using adequate contraception. Adequate contraception includes the use of one or more of the following: surgical sterilisation (tubal ligation), hormonal sterilisation (implant, patch or oral), and double barrier methods (any double combination of: IUD, condom with spermicidal gel, diaphragm, sponge, cervical cap). Reliable contraception must be maintained throughout the study and for 30 days after bevacizumab discontinuation. 14. Uncontrolled, active intraocular inflammation, defined as being greater than or equal to 2+ anterior chamber cell and/or greater than trace vitreal haze and/or signs of active chorioretinitis as per the SUN criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2096 0
Hospital
Name [1] 2096 0
Royal Victorian Eye and Ear Hospital Research Fund
Country [1] 2096 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
Country
Australia
Secondary sponsor category [1] 1902 0
None
Name [1] 1902 0
None
Address [1] 1902 0
Country [1] 1902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3886 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 3886 0
Ethics committee country [1] 3886 0
Australia
Date submitted for ethics approval [1] 3886 0
Approval date [1] 3886 0
06/06/2007
Ethics approval number [1] 3886 0
07/742H

Summary
Brief summary
Macular oedema, or swelling around the macula, results in decreased vision. It is termed "refractory" when it does not adequately respond to the usual treatment methods. It can occur with conditions like diabetic retinopathy or uveitis. Without effective treatment, vision loss can progress and become permanent. Early studies have suggested that a new treatment called Avastin (Bevacizumab) may be effective in treating this type of macular oedema, however further research is required to confirm this.

Choroidal neovascularisation (CNV) is a condition where abnormal blood vessels grow in the back of the eye and causes blurred or distorted vision. Without treatment, vision loss may be quick and severe. There are many causes of CNV, the most common being Age Related Macular Degeneration. Uveitis can also cause this condition. As Avastin (Bevacizumab) has been found to be useful in the treatment of CNV due to AMD, it is expected that it will be useful in cases of CNV from uveitis.

The purpose of this project is to assess whether Avastin (Bevacizumab) is both safe and effective in the treatment of the above conditions, namely:

1. Macular oedema due to diabetic retinopathy
2. Macular oedema due to uveitis
3. Choroidal neovascularisation due to uveitis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27916 0
Address 27916 0
Country 27916 0
Phone 27916 0
Fax 27916 0
Email 27916 0
Contact person for public queries
Name 11002 0
Dr Lyndell Lim
Address 11002 0
Centre for Eye Research Australia,
C/- Royal Victorian Eye and Ear Hospital, Locked Bag 8,
East Melbourne,
VIC, 8002,
Country 11002 0
Australia
Phone 11002 0
03 9929 8399
Fax 11002 0
03 9929 8379
Email 11002 0
[email protected]
Contact person for scientific queries
Name 1930 0
Dr Lyndell Lim
Address 1930 0
Centre for Eye Research Australia
C/- Royal Victorian Eye and Ear Hospital
Locked Bag 8
East Melbourne VIC 8002
Country 1930 0
Australia
Phone 1930 0
03 9929 8399
Fax 1930 0
03 9929 8379
Email 1930 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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