Status:
RECRUITING
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)
Lead Sponsor:
Avirmax Biopharma Inc
Conditions:
Neovascular (Wet) AMD
Eligibility:
All Genders
50-89 years
Phase:
PHASE1
PHASE2
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 w...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06550011
Start Date
August 7 2024
End Date
February 1 2030
Last Update
October 2 2024
Active Locations (4)
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1
California Retina Consultants
Bakersfield, California, United States, 93309
2
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
3
Retina Consultants of Texas - San Antonio
San Antonio, Texas, United States, 78240
4
Retina Consultants of Texas
The Woodlands, Texas, United States, 77384