Clinical trial NCT06550011: 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)
Official title: A Phase 1/2a, Open-Label, Multiple-Cohort, Dose-Escalation 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neovascular (Wet) AMD
Lead sponsor: Avirmax Biopharma Inc
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose Escalation
Primary purpose: TREATMENT

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.

Eligibility 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 ≤ 20/32 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

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.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 52 weeks
Secondary outcomes:
measure: Preliminary Efficacy
timeFrame: 52 weeks
measure: Pharmacokinetics and Pharmacodynamics
timeFrame: 52 weeks
measure: Immunogenicity
timeFrame: 52 weeks
measure: Optimal Dose
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: San Antonio
country: United States
facility: Retina Consultants of Texas - San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
References: