Eye injection of pozelimab for geographic atrophy in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Arensia Exploratory Medicine at the Research Institute of Clinical Medicine
  Tbilisi, Georgia Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.