Neovascular (Wet) AMD
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGABI-110 Low Dose
Low dose. lower than the safety factor of 10 as recommended by the FDA
DRUGABI-110 Medium Dose
Medium dose
DRUGABI-110 High Dose
High Dose
Sponsors
Avirmax Biopharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose Escalation
Eligibility
Sex/Gender
ALL
Age
50 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * General: 1. Must be willing and able to provide written, signed informed consent. 2. Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent Study eye: 3. Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center 4. The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening. 5. BCVA ≤ 20/25 and ≥ 20/250 (≤ 80L and ≥ 30L ETDRS letters) 6. History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment 7. Response to anti-VEGF at trial entry Key
Exclusion criteria
* Study or Fellow Eye: 1. Prior gene therapy, either eye 2. 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 3. History of retinal disease other than wAMD or PCV, study eye 4. Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye. 5. History of (or active) retinal detachment, study eye 6. Uncontrolled glaucoma (defined as IOP \> 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye 7. 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 8. Any prior treatment with photodynamic therapy or laser photocoagulation, study eye 9. History of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 52 weeks | Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary Efficacy | 52 weeks | Change from baseline to Week 52 after ABI-110 treatment in BCVA as assessed by ETDRS chart at a starting distance of 4M |
| Pharmacokinetics and Pharmacodynamics | 52 weeks | Changes in PK and PD by ABI-110 dose level |
| Immunogenicity | 52 weeks | Changes in Anti-AAV2 antibodies (ADA) and anti-VEGF-Trap antibodies in serum |
| Optimal Dose | 52 weeks | To determine the optimal dose of IVT ABI-110 injection for later phases of study |
Countries
United States
Outcome results
None listed