A Phase 1/2a, Open-Label, Multiple-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54- VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
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.
• General:
‣ Must be willing and able to provide written, signed informed consent.
⁃ Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent
‣ Study eye:
⁃ Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center
⁃ The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening.
⁃ BCVA ≤ 20/32 and ≥ 20/250 (≤ 78L and ≥ 30L ETDRS letters)
⁃ History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment
⁃ Response to anti-VEGF at trial entry
⁃ Must be pseudophakic