A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept (Eylea) once every 8 weeks, in participants with diabetic macular edema (DME).
Diabetic Macular Edema (DME) is a swelling of the retinal layers at the back of the eye is a complication of Diabetic Retinopathy. This swelling causes blurred vision and can be found in both Type 1 and Type 2 diabetics.
DME is caused by leaking blood vessels driven by what’s known as ‘vascular endothelial growth factor (VEGF)’. Current standard of care drugs are injected into the eye and work as an “anti-VEGF” stopping and reversing some of this leakage to improve functional vision. Currently available anti-VEGF therapies for DME include aflibercept (market name: Eylea) and ranibizumab (Lucentis). Additionally, some steroid injections may be useful. However, a significant portion of patients do not have clinically significant improvements in vision.
Faricimab (the investigational product in this study) is also an anti-VEGF, however acts on additional inflammatory pathways with the aim of longer lasting results and better visual outcomes than what is currently available and approved for use.
How do I get involved?
Retina Specialists Victoria (RSV) is a member of the Eye Trials Research Network (ETRN) coordinated by the Clinical Trials Research Centre (CTRC) at the Centre for Eye Research Australia (CERA).
The CTRC has conducted more than sixty Investigator Initiated trials and pharmaceutical/biotech industry fully-sponsored trials, including trials in diabetic eye disease, age-related macular degeneration, glaucoma, uveitis and other retinal vascular diseases (e.g. retinal vein occlusion).
Contact a member of the clinical trials team at CERA to see if there are any trial suitable for you:
T: (03) 9929 8076
Are there any costs associated with being in a clinical trial?
Treatments are provided within a clinical trial at no cost. Patients are not charged to participate in a trial, however, they may be required to cover the cost of their transport to and from appointments and routine medication costs.
Our Doctors
The Clinical Trials Research Network draws upon a significant number of world-renowned experts in their field. These physicians lead medical advances through their research with more than a decade of clinical trial experience and many publications to their name. Our Doctors all have close affiliations with CERA and have been Investigators in many prior clinical trials.
For Optometrists
Inclusion criteria
× Currently treated Diabetic (Type 1 or 2)
× Hba1c <10%
× DME ≥325um on OCT
× VA ≤ 6/12
Exclusion Criteria
× Uncontrolled BP >180 / >100
× IVT Anti-VEGF within 3/12
× PRP within 3/12
× High risk PDR
× NVE or NVD >1/2 disc diameter
× Ocular disease other than DR (AMD, RVO, Uveitis, ERM, RD etc)
× Cataract surgery/YAG caps/PRP or focal laser within 3/12
× Any other intraocular surgery
× Corticosteroid treatment or implant within 6/12
× Uncontrolled Glaucoma
× ACIOL
× Active cancer within 12/12
× Renal failure