Cerulea Clinical Trials

Science and Research

Insite

Treat & Extend versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial.

Overview

This study is investigating a new treatment frequency for Diabetic Macular Edema (DME), compared to the standard of care treatment frequency. DME is the build-up of fluid in the retina (a layer of tissue at the back of the eye). This is a common but serious complication of diabetes and is one of the leading causes of vision loss. To treat the fluid build-up, doctors often use a type of medication called anti-vascular endothelial growth factor (Anti-VEGF) that is injected into the affected eye on a set schedule. Faricimab is one specific Anti-VEGF medication currently approved in Australia for the treatment of DME, and is typically injected every 4 weeks for the first 4 doses. Additional doses may be injected at an interval of up to every 16 weeks (4 months).

In this study, we are looking to determine if DME can be effectively managed with less frequent injections of Faricimab, meaning fewer visits and a lower time commitment for patients and hospital and/or clinic staff. Less frequent injections may also reduce the costs of DME treatment. Instead of using the standard fixed dosing schedule for injections, this study will test a new approach that will allow the doctor to adjust how often the injections are given, based on how well the eye is responding to treatment. This is called the Treat & Extend (T&E) Approach. If eligible for the study, participants would be required to attend out site in East Melbourne for the 2 year duration of the trial. For further information about this study please contact Cerulea on (03) 86385300 or email info@ceruleaclinicaltrials.org.au.

  • Principal Investigator
Dr Robyn Troutbeck

Learn more

View this study on ClinicalTrials.gov

See the ClinicalTrials.gov database listing for more detailed information about this study.