Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to Vascular Endothelial Growth Factor (VEGF) Inhibition in Neovascular Age-related Macular Degeneration (nAMD) Within a Clinical Trial Setting
Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to VEGF Inhibition in nAMD Within a Clinical Trial Setting
About This Trial
Neovascular age-related macular degeneration (nAMD), also called wet AMD, can cause serious vision loss. While anti-VEGF (anti Vascular Endothelial Growth Factor) treatments such as ranibizumab help many patients, about 20 40% have a suboptimal response. In this study, the investigators want to identify other factors (beyond VEGF) that might be driving the disease in these non-responding patients. By looking at samples from inside the eye (vitreous humor) and comparing "good responders" to "suboptimal responders", the investigators hope to find potential new treatment approaches or biomarkers for nAMD.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Faricimab
All study eyes will start on the intravitreal ranibizumab loading phase, with the initial injection given within two weeks of the screening visit and overall of x 3 monthly injections. At week 12, patients will be evaluated for their response following the loading phase. Patients who show an absence of IRF, absence of or ≤100µm subretinal fluid (SRF), and no new hemorrhage will be categorized as good responders and will continue with four further monthly intravitreal ranibizumab. Suboptimal responders (defined as the presence of subretinal fluid \> 100 µm, any intraretinal fluid (IRF), or a new hemorrhage) will switch to four doses of monthly intravitreal faricimab.
Ranibizumab
All study eyes will start on the intravitreal ranibizumab loading phase, with the initial injection given within two weeks of the screening visit and overall of x 3 monthly injections. At week 12, patients will be evaluated for their response following the loading phase. Patients who show an absence of IRF, absence of or ≤100µm SRF, and no new hemorrhage will be categorized as good responders and will continue with four further monthly intravitreal ranibizumab. Suboptimal responders (defined as the presence of subretinal fluid \> 100 µm, any intraretinal fluid (IRF), or a new hemorrhage) will switch to four doses of monthly intravitreal faricimab.