A Phase 1, Open Label, Ascending Dose Study to Evaluate the Safety of BBC1501 Administered by Intravitreal Injection for Neovascular Age-Related Macular Degeneration (nAMD)
This open-label study is being conducted to evaluate the initial safety and tolerability of BBC1501 IVT in patients with nAMD. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of IVT BBC1501 in patients with nAMD. The secondary objective of this study is to exploratory of BBC1501 efficacy following 3 ascending dose of BBC1501 in nAMD patient.
• Able to provide voluntary written informed consent on the approved ICF, understand the study requirements, and are willing to follow and complete all the study required procedures.
• Male or female aged ≥ 50 years.
• As per the Investigator's judgment, patients with active CNV lesions (ie, foveal or parafoveal) secondary to nAMD, as confirmed with SD-OCT, FFA, and fundus photography (FP) in the study eye. Patients must have received at least two prior anti-VEGF doses (eg, aflibercept, ranibizumab, bevacizumab, brolicizumab, or faricimab), meeting criteria for non-ideal response
• Active CNV lesions, secondary to nAMD as confirmed with SD-OCT (or SS-OCT), FFA and fundus photography (FP) in the study eye.
• BCVA score of between 73 and 21 letters, inclusive, in the study eye using ETDRS testing (Snellen equivalent score between 20/40 and 20/400, inclusive
• Participant has CST \> 250 μm if measured by Cirrus OCT or \> 270 μm if measured by Spectralis OCT, with presence of intraretinal and/or subretinal fluid
• Participants who have had a washout period of at least six weeks prior to first administration of the IMP for any IVT anti-VEGF medication and, who in the opinion of the investigator, have disease sufficiently stable to enable this interval.