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)

NCT02895815 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: CR108188CNTO2476MDG2003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Visual Acuity; Geographic Atrophy; Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Showing Improvement From Baseline of Greater Than or Equal to (>=) 15 Letters in Best Corrected Visual Acuity (BCVA) at Month 6

  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). The ETDRS chart at 4 meters is considered the 'gold standard' for visual acuity testing in clinical research for its physical and statistical properties.

  Month 6

Secondary Outcomes (20)

• Percentage of Participants Showing Improvement >=15 BCVA Letters From Baseline at 12 Month

  Baseline and Month 12

• Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months

  Baseline, Month 6 and 12

• Change in Mean Number of BCVA Letters From Baseline at 6 and 12 Months

  Baseline, Month 6 and 12

• Change in Growth Rate of Geographic Atrophy (GA) Lesion Documented at Baseline to 6 and 12 Months

  Baseline, Month 6 and 12

• Mean Change in Reading Acuity (RA) From baseline to 6 and 12 Months

  Baseline, Month 6 and 12

Study Arms (3)

CNTO 2476 (6.0 * 10^4 cells)

EXPERIMENTAL

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

Combination Product: CNTO 2476 (6.0 * 10^4 cells)

CNTO 2476 (3.0 * 10^5 cells)

EXPERIMENTAL

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

Combination Product: CNTO 2476 (3.0 * 10^5 cells)

Control Group

NO INTERVENTION

Participants will undergo observations without surgery.

Interventions

CNTO 2476 (6.0 * 10^4 cells) 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 (6.0 * 10^4 cells)

CNTO 2476 (3.0 * 10^5 cells) 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).

CNTO 2476 (3.0 * 10^5 cells)

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 12, 2016
• Study Start: April 9, 2018
• Primary Completion: February 20, 2021
• Study Completion: August 19, 2022
• Last Updated: February 3, 2025

Record last verified: 2025-01