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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental | Low Dose |
|
| Dose level 2 | Experimental | Medium Dose |
|
| Dose level 3 | Experimental | High Dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-110 Low Dose | Drug | Low dose. lower than the safety factor of 10 as recommended by the FDA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 weeks |
| Pharmacokinetics and Pharmacodynamics | Changes in PK and PD by ABI-110 dose level |
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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 ≤ 20/25 and ≥ 20/250 (≤ 80L 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
Key Exclusion Criteria:
Study or Fellow Eye:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants | Bakersfield | California | 93309 | United States | ||
| Bay Area Retina Associates |
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Dose Escalation
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| ABI-110 Medium Dose | Drug | Medium dose |
|
| ABI-110 High Dose | Drug | High Dose |
|
| 52 weeks |
| Immunogenicity | Changes in Anti-AAV2 antibodies (ADA) and anti-VEGF-Trap antibodies in serum | 52 weeks |
| Optimal Dose | To determine the optimal dose of IVT ABI-110 injection for later phases of study | 52 weeks |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Retina Consultants of Texas - San Antonio | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |