Intravitreal Aflibercept for the Treatment of Treatment Resistant Macular Oedema secondary to Retinal Vein Occlusions
A prospective, open-labelled clinical trial to evaluate the efficacy of intravitreal aflibercept for the treatment of treatment resistant macular oedema secondary to retinal vein occlusion
This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for macular oedema secondary to retinal vein occlusion despite regular injections. The study will describe the effectiveness, safety of intravitreal aflibercept and changes in health related quality of life (HRQoL) among these patients.
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Plain Language Summary
Simplified for easier understanding
This study is for people who have a swelling in the back of the eye (macular oedema) caused by a blocked retinal vein, and who have not responded well to existing eye injection treatments. Researchers want to find out if switching to a different medication called aflibercept (Eylea) can reduce the swelling and improve vision.
You may be eligible if:
- You are aged 18 or older
- You have macular oedema caused by a blocked retinal vein (retinal vein occlusion)
- You have already received at least 4 anti-VEGF injections over 6 months with ongoing swelling
- Your vision in the affected eye is between 6/12 and 6/120
You may NOT be eligible if:
- You are pregnant or breastfeeding
- You are a pre-menopausal woman not using contraception
- You have had an eye injection in the study eye within the past 30 days
- You have had eye surgery in the past 2 months
- You have had a stroke or heart attack in the past 3 months
- You have uncontrolled diabetes (HbA1c above 12%) or very high blood pressure (above 180/110)
- Your vision loss is due to another cause such as macular degeneration
Talk to your doctor about whether this trial might be right for you.
This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Get notified about updates and connect with the research team.
Interventions
All subjects will initially receive 3 monthly doses of 2.0mg of intravitreal aflibercept injections and then have 2.0mg of intravitreal aflibercept at two monthly intervals for the subsequent 9 months
All subjects will initially receive 3 monthly doses of 2.0mg of intravitreal aflibercept injections and then have 2.0mg of intravitreal aflibercept at two monthly intervals for the subsequent 9 months.
Locations(1)
Sydney Retina Clinic & Day Surgery - Sydney
NSW, Australia
View Full Details on ANZCTR
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