This study is comparing two different treatment regimens for the treatment of Diabetic Macular Edema (following regimens – Treat and Extend vs. Fixed dosing (current standard of care).
Patients will be randomised to either of the two different treatment regimens and will receive the study drug at different intervals. The study drug is Faricimab which is currently on the market for the treatment of Diabetic Macular Edema.
To be considered for the study, patients must meet specific eligibility criteria, including and not limited to:
- Diabetic Macula Edema – involving the centre of the fovea on Optical Coherence Tomography (Central subretinal thickness (CST) ≥325µm (Spectralis) or ≥305µm (Cirrus)
- Best Corrected Visual Acuity of 80 to 20 letters (Snellen equivalent 20/25 to 20/400)
- HBA1C ≤10%
- Treatment naïve or previously treated with anti-VEGF (DME diagnosis of >2 years
The study duration is around 100 weeks, the number of visits will be determined by the treatment regimen the patient is assigned to and treatment response.
Principal Investigator: Dr Fred Chen
ClinicalTrials.gov Identifier: NCT05610319
You may visit Clinical Trial Registry at Search for: Other terms: NCT05610319 | Card Results | ClinicalTrials.gov for more information regarding Insite 2022-01 study.
To enquire further about this study, please contact the Clinical Trials Office on (08) 9381 0750, or email lionsvisiontrials@lei.org.au
