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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
BBC1501 solution for Intravitreal injection
Benobio Investigational site
Sydney, New South Wales, Australia
NOT_YET_RECRUITINGSydney Hospital
Sydney, Australia
RECRUITINGAssessment 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.
Time frame: Every week up to 4 weeks
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.
Time frame: every 4 weeks up to 12 weeks
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Time frame: Baseline, Week4
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Time frame: Baseline, Week12
Number of patients who initiation of rescue therapy during study
Exploratory using rescue therapy during study and follow-up period
Time frame: Week1, Week12
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