This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV.
This is a Phase 1/2a, open-label, multiple-cohort, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of IVT ABI-110 (AAV2.N54-VEGF-Trap) injection in subjects with wAMD), including symptomatic macular PCV. This trial will include a screening period, confirmation of response to EYLEA (aflibercept), single administration of ABI-110, and follow-up period of 104 weeks after IVT ABI-110 injection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Low dose. lower than the safety factor of 10 as recommended by the FDA
Medium dose
High Dose
California Retina Consultants
Bakersfield, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Safety and Tolerability
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
Time frame: 52 weeks
Preliminary Efficacy
Change from baseline to Week 52 after ABI-110 treatment in BCVA as assessed by ETDRS chart at a starting distance of 4M
Time frame: 52 weeks
Pharmacokinetics and Pharmacodynamics
Changes in PK and PD by ABI-110 dose level
Time frame: 52 weeks
Immunogenicity
Changes in Anti-AAV2 antibodies (ADA) and anti-VEGF-Trap antibodies in serum
Time frame: 52 weeks
Optimal Dose
To determine the optimal dose of IVT ABI-110 injection for later phases of study
Time frame: 52 weeks
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