Efficacy and Safety Study of CNTO 2476 in Participants With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)

NCT ID: NCT02895815

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2022-08-19

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells administered into the subretinal space by the suprachoroidal surgical approach and the subretinal access kit (SRAK-02) in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD).

Detailed Description

This is a Phase 2 study to evaluate the efficacy and safety of a single subretinal administration of CNTO 2476 compared with the untreated control group, as well as to assess the safety and usability profile of the procedure and the device for cell therapy delivery in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD). The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 month, 12 months and every 6 month thereafter. Participant's safety will be monitored throughout the study.

Conditions

Visual Acuity; Geographic Atrophy; Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CNTO 2476 (6.0 * 10^4 cells)

Participants will receive a single subretinal administration of CNTO 2476 (6.0 \* 10\^4 cells) in 50 microliter (mcL) given by subretinal delivery system.

Group Type: EXPERIMENTAL

CNTO 2476 (6.0 * 10^4 cells)

Intervention Type: COMBINATION_PRODUCT

Participants will receive a single subretinal administration of CNTO 2476 (6.0 \* 10\^4 cells) in 50 mcL given by subretinal delivery system (subretinal access kit \[SRAK-02 kit\] and third arm accessory).

CNTO 2476 (3.0 * 10^5 cells)

Participants will receive a single subretinal administration of CNTO 2476 (3.0 \* 10\^5 cells) in 50 mcL given by subretinal delivery system.

Group Type: EXPERIMENTAL

CNTO 2476 (3.0 * 10^5 cells)

Intervention Type: COMBINATION_PRODUCT

Participants will receive a single subretinal administration of CNTO 2476 (3.0 \* 10\^5 cells) in 50 mcL given by subretinal delivery system (SRAK-02 kit and third arm accessory).

Control Group

Participants will undergo observations without surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CNTO 2476 (6.0 * 10^4 cells)

Participants will receive a single subretinal administration of CNTO 2476 (6.0 \* 10\^4 cells) in 50 mcL given by subretinal delivery system (subretinal access kit \[SRAK-02 kit\] and third arm accessory).

Intervention Type: COMBINATION_PRODUCT

CNTO 2476 (3.0 * 10^5 cells)

Participants will receive a single subretinal administration of CNTO 2476 (3.0 \* 10\^5 cells) in 50 mcL given by subretinal delivery system (SRAK-02 kit and third arm accessory).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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
• Confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 28 days prior to initial randomization by the central reading center using fundus photographs and including the following; a) The study eyes must have at least 1 GA lesion that involves the fovea, and a Macular Photocoagulation Study (MPS) disc areas (DA) of >= 1 and <= 7 (1 Macular Photocoagulation Study Disc Area (MPS DA equivalent to 2.54 millimeter (mm)^2 on the retina) determined by screening images of fundus autofluorescence photographs as calculated by the reading center. If GA is multifocal, at least 1 lesion must be >= 0.5 DA, b) GA must be able to be photographed in its entirety and may be contiguous with peripapillary atrophy, c) Retinal photographs, fundus autofluorescence images, and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained d) The imaging center must be able to delineate and confirm peripapillary atrophy with fundus photography and fundus autofluorescence, e) Images must include the central field 1, 2, and 3 field images as defined by the University of Wisconsin standards as well as a supero temporal image to capture the subretinal injection area if possible
• Female participants must be postmenopausal with last menses 12 months prior, or longer without medical reasons (example, treatment with a drug), or a measured follicle stimulating hormone >= 26 milli-international units per milliliter (mIU/mL)
• Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 (Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR value 0.6-1.6). BCVA in the study eye must be worse than the BCVA in the fellow eye at screening
• Male participants must be sterile or willing to use 2 approved methods of contraception from first day postoperatively to 3 months postoperatively

Exclusion Criteria

• Participant has a history of neovascular ("wet") AMD in the study eye, including any evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization. History or evidence of neovascular AMD in the fellow eye is allowed, if antivascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to screening
• A diagnosis of glaucoma with an intraocular pressure (IOP) >= 25 millimeter of mercury (mm Hg) 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)
• Myopia >-8 diopters and participants with >4 diopters of astigmatism, and >+10 diopters of hyperopia
• Previous vitrectomy, retinal detachment repair, submacular surgery, other surgical interventions targeting AMD, scleral buckling or glaucoma filtration surgery or any other extraocular or orbital procedure in the study eye that, in the opinion of the surgeon, would hamper the suprachoroidal cannulation procedure in the study eye

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Other Identifiers

CR108188

Identifier Type: -

Identifier Source: org_study_id

CNTO2476MDG2003

Identifier Type: OTHER

Identifier Source: secondary_id