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)

Description

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.

Conditions

Neovascular (Wet) AMD

Study Overview

Study Details

Study overview

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.

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)

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)

Condition
Neovascular (Wet) AMD
Intervention / Treatment

-

Contacts and Locations

Bakersfield

California Retina Consultants, Bakersfield, California, United States, 93309

Walnut Creek

Bay Area Retina Associates, Walnut Creek, California, United States, 94598

San Antonio

Retina Consultants of Texas - San Antonio, San Antonio, Texas, United States, 78240

The Woodlands

Retina Consultants of Texas, The Woodlands, Texas, United States, 77384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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
  • * 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.

Ages Eligible for Study

50 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avirmax Biopharma Inc,

Study Record Dates

2030-02