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)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2024-08-07

Study Completion:2030-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06550011

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.

Ages Eligible for Study:50 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Wendy Murahashi

CONTACT

650-208-4233

wendy.murahashi@avirmax.com

Study Locations (Sites)

California Retina Consultants

Bakersfield, California, 93309

United States

Bay Area Retina Associates

Walnut Creek, California, 94598

United States

Retina Consultants of Texas - San Antonio

San Antonio, Texas, 78240

United States

Retina Consultants of Texas

The Woodlands, Texas, 77384

United States

Collaborators and Investigators

Sponsor: Avirmax Biopharma Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-07

Study Completion Date2030-02

Study Record Updates

Study Start Date2024-08-07

Study Completion Date2030-02

Terms related to this study

Additional Relevant MeSH Terms

Neovascular (Wet) AMD