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)

Avirmax Biopharma Inc

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Neovascular (Wet) AMD

Treatments: Drug: ABI-110 High Dose; Drug: ABI-110 Low Dose; Drug: ABI-110 Medium Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06550011

Avirmax ABI-110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Dose level 1

Experimental group

Description:

Low Dose

Treatment:

Drug: ABI-110 Low Dose

Dose level 2

Experimental group

Description:

Medium Dose

Treatment:

Drug: ABI-110 Medium Dose

Dose level 3

Experimental group

Description:

High Dose

Treatment:

Drug: ABI-110 High Dose