A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (LUCERNE)
Neovascular age-related macula degeneration is a form of advanced macula degeneration that can cause rapid and severe vision loss.
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified by protocol, compared with aflibercept once every 8 weeks, in participants with neovascular age-related macular degeneration (nAMD).
Faricimab (the investigational product in this study) is an anti-VEGF, however acts on additional inflammatory pathways with the aim of longer lasting results and better visual outcomes than what is currently approved for use.
INCLUSION
- BCVA from 6/9.5 to 6/95
- Treatment Naïve (including macular laser)
- Active Sub-foveal CNV lesion secondary to AMD (can include PCV, classic, occult, Juxtafoveal)
- A total lesion size (including blood, atrophy, fibrosis and neovascularization) of ≤ 9-disc areas.
- Greater than 50 years old
EXCLUSION
- CNV due to any other cause than AMD
- Presence of CSR
- Any macula pathology other than AMD
- Uncontrolled glaucoma
- Vitreous Haemorrhage
- Cataract surgery/YAG laser within 3 months
- Any history of Uveitis
- Previous Avastin
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
F: (03) 9929 8030
E: cera-trials@unimelb.edu.au
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.
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