Evaluating a new injection for wet age-related macular degeneration
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)
This study is testing a new injection for people with wet age-related macular degeneration to see if it is safe and effective in improving their vision.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 50 Years to 89 Years |
| Sex | All |
| Sponsor | Avirmax Biopharma Inc Industry-sponsored |
| Locations | 4 sites (Bakersfield, California and 3 other locations) |
| Trial ID | NCT06550011 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the safety, tolerability, and preliminary efficacy of an intravitreal injection of ABI-110 in patients diagnosed with neovascular (wet) age-related macular degeneration (wAMD), including symptomatic macular polypoidal choroidal vasculopathy (PCV). It is a Phase 1/2a, open-label, multiple-cohort, dose-escalation study that includes a screening period, confirmation of response to prior anti-VEGF treatment, a single administration of ABI-110, and a follow-up period of 104 weeks. The study will evaluate various doses of ABI-110 to determine the optimal dosage for safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 to 89 with a diagnosis of wet AMD who have previously responded to anti-VEGF treatments.
Not a fit: Patients with prior gene therapy or active ocular infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from wet age-related macular degeneration.
How similar studies have performed: Other studies have shown promise with similar gene therapy approaches, but this specific treatment is novel.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Bakersfield, California and 3 other locations
- California Retina Consultants — Bakersfield, California, United States (Recruiting)
- Bay Area Retina Associates — Walnut Creek, California, United States (Recruiting)
- Retina Consultants of Texas - San Antonio — San Antonio, Texas, United States (Recruiting)
- Retina Consultants of Texas — The Woodlands, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Wendy Murahashi
- Email: wendy.murahashi@avirmax.com
- Phone: 650-208-4233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.