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Trial registered on ANZCTR


Registration number
ACTRN12607000244404
Ethics application status
Approved
Date submitted
20/09/2006
Date registered
8/05/2007
Date last updated
8/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravitreous Avastin for diseases of ocular angiogensis
Scientific title
Intravitreous Avastin to improve visual acuity and arrest ocular neovascularization in patients with Age related Macular Degeneration and Severe Diabetic Retinopathy and neovascular glaucoma.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age Related Macular Degeneration 1781 0
Neovascular Glaucoma 1782 0
Proliferative Diabetic retinopathy 1783 0
Condition category
Condition code
Eye 1868 1868 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 1869 1869 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial is a prospective non randomised intervention with 1.25mg of intravitreous avastin. The trial is not controlled, nor is there a crossover.

Intravitreous Avastin will be injected at baseline into the study eye. The patient will be re-examined in 4 weeks and re-injected based on clinical findings.

These are
1. The presence or absence of sub-retinal and intra-retinal fluid in patients with Age related Macular degeneration, (as determined by Optical coherence tomography).

2. The presence of ocular neovascularization in patients with Neovascular Glaucoma or Diabetic retinopathy (as determined by Slit lamp examination).

If patients do not have these findings treatment will be deferred and the patient examined in a further 4 weeks and the same assessment made once again.

The minimum intervention is one(at baseline) the maximum is 12 for the duration of the trial.
Intervention code [1] 1368 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Historical

Outcomes
Primary outcome [1] 2654 0
1. Snellen visual acuity (measured in all patients)
Timepoint [1] 2654 0
At 3 monthly intervals and as well as baseline, until the end of the study at 12 months.
Primary outcome [2] 2655 0
2.the presence or absence of Intra-retinal and sub-retinal fluid (in patients with Age related macular degeneration only).
Timepoint [2] 2655 0
Assesed by Optical coherence tomography. Measured at 3 monthly intervals and at baseline, until completion of the study at 12 months.
Primary outcome [3] 2656 0
3. The presence or absence of ocular neovascularization (in patients with neovascular glaucoma and diabetic retinopathy). Assessed by Slit lamp examination.
Timepoint [3] 2656 0
Measured at baseline and at 4 weekly intervals until the completion of the study in 12 months.
Primary outcome [4] 2657 0
4. Intraocular pressure (in patients with neovascular glaucoma). This will be measured by Goldman tonometry.
Timepoint [4] 2657 0
Measured at baseline (at enrolment) and 3 monthly following treatment until 12 months at the completion of the study.
Secondary outcome [1] 4507 0
Incidence of severe visual loss (visual acuity <6/60).
Timepoint [1] 4507 0
This will be measured at baseline, then 3 monthly until 12 months.

Eligibility
Key inclusion criteria
1. Neovascular Age related macular degeneration.2. Neovascular glaucoma3. Proliferative diabetic retinopathy4. subjects able to give informed consent.
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of unstable cardiovascular disease (CVA, TIA or AMI)2. Previous treatment with Lucentis3. Intravenous treatment with Avastin for systemic malignancy4. Inability to read and fully understand detailed consent form5. first eyes in patients with AMD6. allergy to AvastinCVA- strokeAMI-heart attackTIA- mini-stroke.

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
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2016 0
Hospital
Name [1] 2016 0
Royal Victorian Eye and Ear Hospital
Address [1] 2016 0
Country [1] 2016 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
Country
Australia
Secondary sponsor category [1] 1826 0
None
Name [1] 1826 0
N/A
Address [1] 1826 0
Country [1] 1826 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3743 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 3743 0
Ethics committee country [1] 3743 0
Australia
Date submitted for ethics approval [1] 3743 0
Approval date [1] 3743 0
Ethics approval number [1] 3743 0
06/662H

Summary
Brief summary
We propose to investigate the medium term safety and efficacy of the intravitreous use of Avastin ( Bevacizumab) to treat neovascular AMD (age related macular degeneration).

The trial will be 12 to 18 months in duration, during which patients with (currently) untreatable AMD will be administered Avastin by intravitreous (into the vitreous cavity of the eye) injection. They will be monitered closely by conventional ophthalmic means (clinical assesment, fundus flurosceiun angiograhy etc…) and phyisical examination and assesment of cardiovascular parameters under the supervision of a consultant cardiologist.

Avasatin (Bevacizumab, Genentech, Inc., South San Francisco, CA) is a humanized monoclonal antibody to VEGF (vascular endothelial growth factor) designed for intravenous administration and approved for the treatment of colorectal cancer. Its mechanism of action is to supress the action of the VEGF molecule and thereby prevent blood vessel growth with tumors. Its use in AMD is through the same mechanism. It is now widely used amongts retinal departments worldwide as an "off label" treatment for the full spectrum of neovascular (new blood vessel) AMD. The treatment has gained wdespread anecdotal noterity for its remarkable effect which has been transmitted to collegues by unconventially and informally by word of mouth and email.

Objective and dispassionate analysis of Avastin in this disease has not yet been published in the peer reviewed litreature. There are several small cases series and some observational data (1-5). These reports, as well as the widespread anecdotal opinion do stongly suggest that Avastin is safe to the eye in the short term, and at least in a proportion of patients, dramatically effective, well beyond current coventional treatment.

The primary aim of our study will be to assess the medium term SAFETY of Avastin, (both to the eye and to gerneral health) as well. to assses the EFFICACY of Avastin in treating neovascular AMD (choroidal neovacular membrane and polypoidal choroidal vasculopathy).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27595 0
Address 27595 0
Country 27595 0
Phone 27595 0
Fax 27595 0
Email 27595 0
Contact person for public queries
Name 10557 0
Dr Salmaan H Qureshi
Address 10557 0
32 Gisborne street East Melbourne
Melbourne Victoria 3106
Country 10557 0
Australia
Phone 10557 0
03 99298666
Fax 10557 0
Email 10557 0
shq@unimelb.edu.au
Contact person for scientific queries
Name 1485 0
Salmaan Qureshi
Address 1485 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne 3001 VIC
Country 1485 0
Australia
Phone 1485 0
03 9929 8666
Fax 1485 0
Email 1485 0
shq@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
No Results