One-Shot gene therapy could replace monthly eye injections for wet AMD
NCT ID NCT06550011
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a single injection of ABI-110 gene therapy into the eye for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The goal is to see if it is safe and can reduce the need for frequent anti-VEGF injections by helping the eye produce its own medicine. About 18 adults aged 50 to 89 with wet AMD will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ≤ 20/25 and ≥ 20/250 (≤ 80L 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bay Area Retina Associates
Walnut Creek, California, 94598, United States
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California Retina Consultants
Bakersfield, California, 93309, United States
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Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
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Retina Consultants of Texas - San Antonio
San Antonio, Texas, 78240, United States