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)

Last updated: September 30, 2024
Sponsor: Avirmax Biopharma Inc
Overall Status: Active - Recruiting

Phase

1/2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

ABI-110 Low Dose

ABI-110 High Dose

ABI-110 Medium Dose

Clinical Study ID

NCT06550011
Avirmax ABI-110
  • Ages 50-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 informedconsentStudy eye:

  3. Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the CentralReading Center

  4. The macular neovascularization lesion must be confirmed as determined by theCentral 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 meaningfulresponse to anti-VEGF and continued need for anti-VEGF treatment

  7. Response to anti-VEGF at trial entry

  8. Must be pseudophakic

Exclusion

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 ofidiopathic 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, orretinal 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 asintravitreal steroid injection or investigational product, in the 6 monthsprior to screening, study eye

  8. Any prior treatment with photodynamic therapy or laser photocoagulation, studyeye

  9. History of glaucoma filtration, vitrectomy, or other procedure that couldaffect drug distribution or clearance, study eye.

Study Design

Total Participants: 18
Treatment Group(s): 3
Primary Treatment: ABI-110 Low Dose
Phase: 1/2
Study Start date:
August 07, 2024
Estimated Completion Date:
February 28, 2030

Study 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.

Connect with a study center

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Site Not Available

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

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