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Purpose

This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA). The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood and the fluid in the eye at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Part A will not be masked (Open label) and part B is masked

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A
  • Drug: Pozelimab
    Administered per the protocol
    Other names:
    • REGN3918
Experimental
Part B
  • Drug: Pozelimab
    Administered per the protocol
    Other names:
    • REGN3918

Recruiting Locations

Colorado Retina Associates
Lakewood 5427946, Colorado 5417618 80228

Austin Retina Associates
Austin 4671654, Texas 4736286 78705

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.