A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy
Condition: Visual Acuity; Geographic Atrophy; Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: CNTO 2476 3.0 x 10^5 cells; Subretinal Delivery System
Intervention description: Participants will receive a single subretinal administration of CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL) given by subretinal Delivery System.; Participants will receive CNTO 2476 by using the Delivery System.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Best Corrected Visual Acuity; Geographic Atrophy; Macular Degeneration; CNTO 2476

Summary:

      The purpose of this study is to evaluate the safety and performance profile of the
      suprachoroidal surgical approach and the Delivery System.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration
             (AMD) confirmed within 45 days prior to initial randomization verified by the central
             reading center

          -  Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early
             Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution
             (logMAR) value 0.6-1.6]. The treatment eye will be that with the worse BCVA at
             Screening. If BCVA is clinically equivalent, the eye with the larger GA determines the
             study eye

          -  Participant is a suitable candidate for ophthalmologic surgery, is willing and able to
             comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests
             and other study procedures. Participant has met criteria of the surgery center
             anti-coagulation protocol, if applicable

          -  Each participant must sign an informed consent form (ICF) indicating that he or she
             understands the purpose of and procedures required for the study and are willing to
             participate in the study

        Exclusion Criteria:

          -  Participant has a history of neovascular ("wet") AMD in the treatment eye, including
             evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal
             neovascularization or fluid. In cases where imaging is inconclusive, review of the
             case with the study site, considering history and imaging will determine eligibility.
             History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular
             endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks
             prior to Screening

          -  Geographic atrophy secondary to any causes other than AMD in either eye

          -  A diagnosis of glaucoma with an intraocular pressure (IOP) greater than or equal to
             (>=) 25 millimeter of mercury (mmHg) while being treated with an ocular hypotensive
             drug. Treatment should be no more than 1 drug preparation/combination, which can
             contain 1 or 2 ocular hypotensive active ingredients; participants receiving more than
             2 ocular hypotensive active ingredients are excluded

          -  Nuclear sclerotic cataract, cortical spoking, posterior subcapsular cataract above
             Grade 2 per Age Related Eye Disease Study (AREDS) scale or any other ophthalmologic
             condition that reduces the clarity of the media that, in the opinion of the
             investigator or reading center, interferes with ophthalmologic examination (example,
             corneal abnormalities, inadequate pupillary dilation), surgery or imaging in the study
             eye

          -  Myopia greater than minus (>-) 8 diopters and participants with greater than (>) 4
             diopters of astigmatism, and greater than plus (>+) 10 diopters of hyperopia