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.
Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study.
Glaucoma, evidenced by an IOP of > 21 mmHg despite up to 4 glaucoma medications, or evidence of glaucomatous visual field loss or has advanced glaucoma (e.g., prior shunt surgery) in either eye
Evidence of any other ocular disease other than nAMD in the study eye that may confound the outcome of the study (eg, active diabetic retinopathy, posterior uveitis, pseudovitelliform macular degeneration, moderate/severe myopia).
Participants with advanced nAMD and no prognosis of BCVA as per Investigator's judgement (e.g. due to macular OCT signs of atrophy or photoreceptors disruption, or macular/foveal subretinal hemorrhage).
Sequential
BBC1501
DrugBBC1501 solution for Intravitreal injection
Assessment of ophthalmic and systemic TEAEs, during study period
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 4 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
Assessment of ophthalmic and systemic TEAEs, during study period
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 12 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Number of patients who initiation of rescue therapy during study
Exploratory using rescue therapy during study and follow-up period
Change in CNV size according to fluorescein angiogram
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
Change in CNV size according to fluorescein angiogram
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
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