A Multicentre Randomised Clinical Trial Of Laser Treatment Plus Intravitreal Traimcilone For Diabetic Macular Oedema
Funder
National Health and Medical Research Council
Funding Amount
$529,500.00
Summary
A diagnosis of diabetes immediately confers a 25 fold increase in a person's risk of blindness. The macula is the vision centre of the retina, which is like the film in a camera. In people with diabetes, swelling of the macula (macular oedema) due to leakage of retinal blood vessels is the commonest cause of loss of vision. Laser treatment is proven to be helpful in reducing the risk of vision loss in eyes with diabetic macular oedema (DMO), but it does not work in 40% of cases. Injection of slo ....A diagnosis of diabetes immediately confers a 25 fold increase in a person's risk of blindness. The macula is the vision centre of the retina, which is like the film in a camera. In people with diabetes, swelling of the macula (macular oedema) due to leakage of retinal blood vessels is the commonest cause of loss of vision. Laser treatment is proven to be helpful in reducing the risk of vision loss in eyes with diabetic macular oedema (DMO), but it does not work in 40% of cases. Injection of slow release steroids is an emerging revolutionary treatment for DMO. We are the first in the world to perform a randomised clinical trial of triamcinolone injection into the eye with DMO that has failed laser treatment. A randomised clinical trial is when an equal number of eyes are randomly allocated to the treatment and placebo (no treatment) groups, so that none of the patients or the doctors knows whether each particular eye is receiving treatment or placebo. The preliminary results of our study in progress have proved that, at least in the short term, intravitreal triamcinolone (IVTA) leads to reduction of macular oedema and improved vision. We now propose a two year randomised clinical trial to test whether the combination of IVTA with laser treatment will result in a further improvement in vision in eyes with DMO. We are in a unique position to conduct such a study, having recently concluded the world's first randomised clinical trial of IVTA for wet age-related macular degeneration in 151 eyes. We have extensive experience of IVTA's significant but manageable adverse event profile. The Australian Retinal Collaboration is a group of academic retinal specialists who are committed to attaining the highest possible standards in clinical research in Australia for common blinding conditions of the retina. The results of the proposed study are likely to lead directly to a reduction of the risk of vision impairment and blindness in people with diabetes.Read moreRead less
An Open-label Extension Of A Randomised Clinical Trail Of Intravitreal Triamcinolone For Diabetic Macular Oedema
Funder
National Health and Medical Research Council
Funding Amount
$167,733.00
Summary
A 25 fold increase in the risk of going blind on diagnosis of diabetes is one of the most daunting threats that patients face. Most cases of vision impairment in diabetes are due to macular oedema that persists or recurs after laser treatment. There are now a number of uncontrolled, anecdotal reports that intravitreal triamcinolone (IVTA) is highly effective for the treatment of diabetic macular edema which is refractory to conventional laser treatment. We commenced the first placebo-controlled, ....A 25 fold increase in the risk of going blind on diagnosis of diabetes is one of the most daunting threats that patients face. Most cases of vision impairment in diabetes are due to macular oedema that persists or recurs after laser treatment. There are now a number of uncontrolled, anecdotal reports that intravitreal triamcinolone (IVTA) is highly effective for the treatment of diabetic macular edema which is refractory to conventional laser treatment. We commenced the first placebo-controlled, double masked clinical trial of intravitreal triamcinolone for refractory macular oedema in 2002. The 3 month results from this study provide the first scientific proof of principle that intravitreal triamcinolone reduces macular thickness and improves vision. The two year results will be available in March 2005, but confidential interim analysis of efficacy data in September 2004 suggested that the beneficial effect of triamcinolone treatment persisted. Thus it appears that treatment with intravitreal triamcinolone may be the most significant development for the prevention of blindness in people with diabetes since the introduction of laser treatment. It would also be a highly cost-effective intervention that could be administered by general ophthalmologists. The treatment cannot be recommended for routine use, however, until its long term efficacy and safety have been established. Since we already have a well studied group of patients who have received treatment for 2 years, we are in a unique position to extend the study in order to provide the long-term (5-year) safety and efficacy data that does not appear to be forthcoming from any other source. The results of this study will significantly improve knowledge of long-term outcomes of local high dose steroids for diabetic macular oedema, allowing the treatment to be used more rationally. Thus the study is very likely to directly reduce the risk of blindness in people with diabetes.Read moreRead less
Clinical Trial Of Intravitreal Injections Of Dexamethasone Vs Bevacizumab In Diabetic Foveal Oedema Resistant To Laser
Funder
National Health and Medical Research Council
Funding Amount
$336,398.00
Summary
Diabetic macular oedema (swelling in the back of the eye) occurs in 20% of patients who have had diabetes for 10 years, and causes progressive vision loss. This project aims to determine whether there may be a difference between treatment with bevaciumab -VEGF inhibitor- and steroids used as eye injections inpatients with diabetic macular oedema losing vision despite standard laser treatment.
A Randomised Control Trial Of Physiotherapy And Corticosteroid Injections Of Lateral Epicondylalgia In Primary Care.
Funder
National Health and Medical Research Council
Funding Amount
$193,775.00
Summary
Musculoskeletal conditions account for the third leading cause of health systems expenditure in Australia. Lateral epicondylalgia (tennis elbow) is such a condition and is often treated in primary care. Both the individual and community are affected by this condition: 7 per 1000 patients seeing their medical doctor have this condition. Most are not tennis related. On average 10-30% of sufferers take 12 weeks off work. The condition may last 6-48 months and it tends to become stubborn to treatmen ....Musculoskeletal conditions account for the third leading cause of health systems expenditure in Australia. Lateral epicondylalgia (tennis elbow) is such a condition and is often treated in primary care. Both the individual and community are affected by this condition: 7 per 1000 patients seeing their medical doctor have this condition. Most are not tennis related. On average 10-30% of sufferers take 12 weeks off work. The condition may last 6-48 months and it tends to become stubborn to treatment and recurs often. Two popular treatment options that are commonly prescribed for the management of lateral epicondylalgia are physiotherapy and corticosteroid injections. To date there is little evidence supporting physiotherapy, especially current best practice methods such as manual therapy and therapeutic exercise. The lack of evidence is largely due to a small number of studies of physiotherapy, most of which are of poor quality and of treatments that are currently deemed to be less than optimal. A larger number of studies of corticosteroid injections have shown that corticosteroid injections are beneficial in the short term (3-6 weeks), but not over 12 months where they are associated with greater recurrence rates. Manual therapy has been shown to have short term pain relieving effects and therapeutic exercise exerts long standing improvements in this condition. It is proposed that the addition of manual therapy to therapeutic exercise will have superior short- and long-term effects. This project will conduct a randomised clinical trial to evaluate this proposition and also the factors associated with success, failure or recurrence rates. A cost-benefit analysis will also be conducted to calculate the relative economic merits of the treatments. A tangible outcome of this project will be the development of clinical guidelines for the most effective method of treating lateral epicondylalgia in primary health care.Read moreRead less