Type 3 macular neovascularization (MNV) is a subtype of neovascular age-related macular degeneration accounting for 10-20% of cases, notable for high rates of bilateral involvement and risk of profound vision loss, particularly if undertreated. Early and proactive therapy is crucial to prevent progression and preserve vision.
Faricimab offers potential advantages in this setting. Eyes with type 3 MNV often show thin choroid, reticular pseudodrusen, and high GA risk, reflecting compromised choroidal perfusion. While anti-vascular endothelial growth factor (VEGF) agents suppress neovascularization, prolonged VEGF blockade may impair choriocapillaris health. Ang-2 inhibition, by promoting Tie2 activation and vascular stability, may protect choriocapillaris and reduce widespread retinal edema and hemorrhages observed in type 3 MNV.
Finally, while treat-and-extend is widely used in practice, existing trials (TENAYA, LUCERNE) applied broader extension intervals than typically used clinically. In type 3 MNV, where undertreatment carries severe consequences, a more stringent faricimab-based treat-and-extend regimen with 2-week interval adjustments warrants investigation.
Signed Informed Consent Form
Age > 50 years at the time of signing Informed Consent Form
Participants who are able to comply with the study protocol, in the investigator's judgment
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (will be defined in details in protocol)
Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1
Any major illness or major surgical procedure within 1 month before screening
Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of < 6 (Grade Group of 1) and a stable prostate-specific antigen for >12 months
Continuous use of any medications and treatments (which will be indicated in the Prohibited Therapy section in protocol)
Single group
Intravitreal faricimab injection
Drug* Initial loading injections : every 4 weeks by 12weeks * Treat and extend injection(\~76 week) : Week 20 - Week 76 TAE is initiated with a minimum injection interval of 8 weeks. If no recurrence is observed, the interval is extended by 2 weeks at a time, up to a maximum of 16 weeks. In the event of recurrence, the injection interval is reduced to 8 weeks, regardless of the previous schedule. The minimum injection interval remains 8 weeks.
Change in CST (central subfield thickness)
Change in central retinal thickness, as measured by optical coherence tomography, from baseline to week 76
Change in best-corrected visual acuity (BCVA)
Change in BCVA from baseline to week 76
Choroidal thickness
Change in choroidal thickness from baseline to week 76
Geographic atrophy (GA) development
Proportion of eyes experiencing development of GA from baseline to week 76
Fluid resolution
Proportion of eyes experiencing complete resolution of retinal fluids at week 20, 52, and 76
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
