A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy

Overview

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

Full Title of Study: “A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 5, 2019

Detailed Description

This is a multicenter (when more than one hospital or medical school team work on a medical research study) study which includes an initial unmasked safety phase. The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be monitored throughout the study.

Interventions

  • Drug: CNTO 2476 3.0 x 10^5 cells
    • 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.
  • Device: Subretinal Delivery System
    • Participants will receive CNTO 2476 by using the Delivery System.

Arms, Groups and Cohorts

  • Experimental: Open-Label Safety Run-in Phase: Treatment Group
    • Participants will receive CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL). CNTO 2476 will be delivered using the custom-designed Delivery System.

Clinical Trial Outcome Measures

Primary Measures

  • Safety Profile of the Surgical Procedure and Delivery System in Participants
    • Time Frame: Up to Month 1
    • The number of eyes with treatment related ocular adverse events will be evaluated to determine the safety profile of suprachoroidal surgical approach and the Delivery System after drug administration in participants.
  • Performance Profile of the Surgical Procedure and Delivery System in Participants
    • Time Frame: Up to Month 1
    • The ability of the Delivery System to deliver CNTO 2476 cells to the subretinal space (percentage of cases with successful cell delivery) will be evaluated to determine the performance profile of suprachoroidal surgical approach and the Delivery System after drug administration in participants.

Secondary Measures

  • Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 12 Months
    • Time Frame: Baseline to Month 12
    • The BCVA testing performed after refraction and under standardized photopic lighting conditions and distance using an Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR chart).
  • Mean Change in Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months
    • Time Frame: Baseline, Month 6 and 12
    • The BCVA testing performed after refraction and under standardized photopic lighting conditions and distance using an Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR chart).
  • Change in Growth Rate of Geographic Atrophy (GA) Lesion Documented at Baseline to 6 and 12 Months
    • Time Frame: Baseline, Month 6 and 12
    • Lesion size will be determined by fundus autofluorescence (FAF).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen Research & Development, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Research & Development, LLC Clinical Trial, Study Director, Janssen Research & Development, LLC

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