RecruitingPhase 4ACTRN12614001307695

Intravitreal Aflibercept for the Treatment of Treatment Resistant Diabetic Macular Oedema

A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of treatment resistant diabetic macular oedema


Sponsor

Andrew Chang

Enrollment

50 participants

Start Date

Jul 6, 2014

Study Type

Interventional

Conditions

Summary

This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for DMO and have persisting DMO 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 testing a drug called aflibercept (injected into the eye) for patients with diabetic macular oedema — a condition where fluid builds up in the back of the eye due to diabetes, causing blurry vision or vision loss. Some patients do not respond well to the usual eye injection treatments. This study will evaluate whether aflibercept can improve vision and reduce swelling in these treatment-resistant cases. You may be eligible if: - You are 18 years or older - You have type 1 or type 2 diabetes - You have swelling in the central part of your retina (diabetic macular oedema) that has not improved after at least 4 previous anti-VEGF eye injections over at least 6 months - Your vision in the affected eye is between a Snellen equivalent of 6/6 and 6/60 You may NOT be eligible if: - You are pregnant or breastfeeding - You are a pre-menopausal woman not using contraception - You have had eye surgery, laser treatment, or a vitrectomy recently in that eye - Your blood sugar is very poorly controlled (HbA1c above 12%) - You have had a recent stroke or heart attack (within 3 months) - You have uncontrolled glaucoma or high blood pressure 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

All subjects will initially receive 5 monthly doses of 2.0mg of intravitreal aflibercept injections and then have 2.0mg of intravitreal aflibercept at two monthly intervals for the subsequent 7 months

All subjects will initially receive 5 monthly doses of 2.0mg of intravitreal aflibercept injections and then have 2.0mg of intravitreal aflibercept at two monthly intervals for the subsequent 7 months.


Locations(1)

Sydney Retina Clinic & Day Surgery - Sydney

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614001307695


Related Trials