Retina Research Institute of Texas | Abilene, TX
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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.
Full description
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.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
Study or Fellow Eye:
Primary purpose
Allocation
Interventional model
Masking
18 participants in 3 patient groups
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Central trial contact
Wendy Murahashi
Data sourced from clinicaltrials.gov
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