Overview
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.
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.
Eligibility
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:
- Prior gene therapy, either eye
- Any active ocular/intraocular infection or inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis) or history of idiopathic or autoimmune-associated uveitis, either eye
- History of retinal disease other than wAMD or PCV, study eye
- Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye.
- History of (or active) retinal detachment, study eye
- Uncontrolled glaucoma (defined as IOP > 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye
- History of intravitreal therapy, (other than anti-VEGF therapy) such as intravitreal steroid injection or investigational product, in the 6 months prior to screening, study eye
- Any prior treatment with photodynamic therapy or laser photocoagulation, study eye
- History of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.