RecruitingPhase 1ACTRN12607000244404

Intravitreous Avastin for diseases of ocular angiogensis

Intravitreous Avastin to improve visual acuity and arrest ocular neovascularization in patients with Age related Macular Degeneration and Severe Diabetic Retinopathy and neovascular glaucoma.


Sponsor

Royal Victorian Eye and Ear Hospital

Enrollment

50 participants

Start Date

Aug 1, 2006

Study Type

Interventional

Conditions

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).


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how safe and effective it is to inject a medicine called Avastin (bevacizumab) directly into the eye to treat a type of age-related macular degeneration (AMD) — the most common cause of vision loss in older adults. AMD causes abnormal blood vessels to grow under the retina and leak fluid, blurring or destroying central vision. Avastin blocks the signal that tells these blood vessels to grow. While it is approved to treat certain cancers by IV injection, this study is testing its use in the eye for eye diseases, including AMD and diabetic eye complications. You may be eligible if: - You are between 18 and 100 years of age - You have been diagnosed with neovascular (wet) age-related macular degeneration, neovascular glaucoma, or proliferative diabetic retinopathy - You are able to give informed consent You may NOT be eligible if: - You have had an unstable cardiovascular event such as a stroke, mini-stroke, or heart attack - You have previously been treated with Lucentis (ranibizumab) for your eye condition - You are currently receiving IV Avastin treatment for cancer - You are unable to read and fully understand the consent form - You have an allergy to Avastin - This would be your first affected eye with AMD (the study is for the second eye) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 baseli

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.


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ACTRN12607000244404


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