None listed
Conditions
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).
Interventions
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 presen
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.
Sponsors
Royal Victorian Eye and Ear Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Neovascular Age related macular degeneration.2. Neovascular glaucoma3. Proliferative diabetic retinopathy4. subjects able to give informed consent.
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.
Outcome results
None listed