Eye injection of pozelimab for geographic atrophy in adults
A Phase 1 Dose-Escalation and Repeated-Dose Study of the Safety and Tolerability of Intravitreal Pozelimab in Participants With Geographic Atrophy
This study will test whether injections of pozelimab into the eye are safe and well tolerated in adults with geographic atrophy from age-related macular degeneration.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | pozelimab |
| Locations | 5 sites (Lakewood, Colorado and 4 other locations) |
| Trial ID | NCT07230834 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, interventional study giving intravitreal (eye) injections of the experimental drug pozelimab to adults with geographic atrophy (GA) secondary to age-related macular degeneration. The main goal is to monitor safety and tolerability after dosing, with regular eye exams and tests of vision. The study will also measure drug levels in the blood and eye fluid and check whether participants develop antibodies against the drug. Participants with neovascular AMD, other retinal diseases, active eye inflammation, or prior intravitreal treatments (except complement agents) are excluded.
Who should consider this trial
Good fit: Adults with GA due to dry AMD, a lesion area of about 2.5 mm² or larger in the study eye, and best-corrected visual acuity of approximately 60 ETDRS letters (≈20/63) or worse would be the intended participants.
Not a fit: People with GA from causes other than dry AMD, active or prior macular neovascularization, significant concurrent eye disease, active ocular inflammation or infection, or prior intravitreal treatments (other than complement agents) would not be eligible and are unlikely to benefit from this Phase 1 study.
Why it matters
Potential benefit: If safe and tolerable, this approach could become a new intravitreal therapy that may slow GA progression and help preserve central vision.
How similar studies have performed: Other intravitreal complement-targeting therapies have shown the ability to slow GA lesion growth in some trials, so this approach builds on prior positive but variable results in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Study eye with diagnosis of GA of the macula secondary to AMD, as determined by the investigator 2. Study eye with total GA area measuring approximately one disc area or greater in size (2.5 mm\^2 or larger) at screening, as determined by the Central Reading Center (CRC), as described in the protocol 3. Best-Corrected Visual Acuity (BCVA) of 60 letters or worse using the Early Treatment Diabetic Retinopathy Score (ETDRS) charts (Snellen equivalent of \~ ≤20/63) in the study eye at screening and baseline visit Key Exclusion Criteria: 1. GA (macular atrophy) in either eye due to causes other than dry AMD 2. History or current evidence of macular neovascularization and/or retinal exudation in either eye 3. Concurrent eye disease (elevated Intraocular Pressure (IOP) \>25mm Hg, diabetic retinopathy, ocular infections/inflammation) 4. Prior or current intravitreal (IVT) treatment of any kind for any indication in either the study or fellow eye, except complement inhibitor therapy for GA, as long as last dose was ≥3 months prior to screening 5. Any prior systemic treatment for dry AMD, except oral supplements or vitamins 6. History or current use of systemic complement inhibitor therapy Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Where this trial is running
Lakewood, Colorado and 4 other locations
- Colorado Retina Associates — Lakewood, Colorado, United States (Recruiting)
- Ophthalmic Consultants of Boston — East Weymouth, Massachusetts, United States (Recruiting)
- Austin Retina Associates — Austin, Texas, United States (Recruiting)
- Retina Foundation of the Southwest — Dallas, Texas, United States (Recruiting)
- Retina Consultants Texas — The Woodlands, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
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.