Clinical 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)
NCT ID: NCT06550011
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2024-08-07
2030-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose level 1
Low Dose
ABI-110 Low Dose
Low dose. lower than the safety factor of 10 as recommended by the FDA
Dose level 2
Medium Dose
ABI-110 Medium Dose
Medium dose
Dose level 3
High Dose
ABI-110 High Dose
High Dose
Interventions
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ABI-110 Low Dose
Low dose. lower than the safety factor of 10 as recommended by the FDA
ABI-110 Medium Dose
Medium dose
ABI-110 High Dose
High Dose
Eligibility Criteria
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Inclusion Criteria
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 ≤ 20/32 and ≥ 20/250 (≤ 78L 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
8. Must be pseudophakic
Exclusion Criteria
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.
50 Years
89 Years
ALL
No
Sponsors
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Avirmax Biopharma Inc
INDUSTRY
Responsible Party
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Locations
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California Retina Consultants
Bakersfield, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Avirmax ABI-110
Identifier Type: -
Identifier Source: org_study_id
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