ANZCTR - Registration

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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

Neovascular Glaucoma

Proliferative Diabetic retinopathy

Condition category

Condition code

Eye

Diseases / disorders of the eye

Metabolic and Endocrine

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]

Treatment: Drugs

Comparator / control treatment

No comparator.

Control group

Historical

Outcomes

Primary outcome [1]

1. Snellen visual acuity (measured in all patients)

Timepoint [1]

At 3 monthly intervals and as well as baseline, until the end of the study at 12 months.

Primary outcome [2]

2.the presence or absence of Intra-retinal and sub-retinal fluid (in patients with Age related macular degeneration only).

Timepoint [2]

Assesed by Optical coherence tomography. Measured at 3 monthly intervals and at baseline, until completion of the study at 12 months.

Primary outcome [3]

3. The presence or absence of ocular neovascularization (in patients with neovascular glaucoma and diabetic retinopathy). Assessed by Slit lamp examination.

Timepoint [3]

Measured at baseline and at 4 weekly intervals until the completion of the study in 12 months.

Primary outcome [4]

4. Intraocular pressure (in patients with neovascular glaucoma). This will be measured by Goldman tonometry.

Timepoint [4]

Measured at baseline (at enrolment) and 3 monthly following treatment until 12 months at the completion of the study.

Secondary outcome [1]

Incidence of severe visual loss (visual acuity <6/60).

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/08/2006

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]

Hospital

Name [1]

Royal Victorian Eye and Ear Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Victorian Eye and Ear Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Victorian Eye and Ear Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Salmaan H Qureshi

Address

32 Gisborne street East Melbourne
Melbourne Victoria 3106

Country

Australia

Phone

03 99298666

Fax

shq@unimelb.edu.au

Contact person for scientific queries

Name

Salmaan Qureshi

Address

Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne 3001 VIC

Country

Australia

Phone

03 9929 8666

Fax

shq@unimelb.edu.au

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

No additional documents have been identified.

Trial Review

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