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

NCT02659098 | Completed Phase 2 Results DMC

• 2 other identifiers: CR106814CNTO2476MDG2002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Visual Acuity; Geographic Atrophy; Macular Degeneration

Keywords

Best Corrected Visual Acuity; Geographic Atrophy; Macular Degeneration; CNTO 2476

Outcome Measures

Primary Outcomes (18)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye

  Best corrected visual acuity (BCVA) was assessed in the study eye (Treated eye). BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 1

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye

  BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 2

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye

  BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 3

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye

  BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 6

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye

  BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 12

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye

  BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 18

• Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye

  BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 24

• Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye

  BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 30

• Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye

  BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 36

• Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 1

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 2

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 3

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 6

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 12

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 18

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 24

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 30

• Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye

  BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

  Baseline and Month 36

Secondary Outcomes (8)

• Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye

  Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36

• Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye

  Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36

• Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye

  Baseline, Months 6 and 12

• Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye

  Baseline, Months 6 and 12

• Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye

  Baseline, Months 6 and 12

Study Arms (1)

Open-Label Safety Run-in Phase: Treatment Group

EXPERIMENTAL

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.

Drug: CNTO 2476 3.0 x 10^5 cells; Device: Subretinal Delivery System

Interventions

CNTO 2476 3.0 x 10^5 cells DRUG

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.

Open-Label Safety Run-in Phase: Treatment Group

Subretinal Delivery System DEVICE

Participants will receive CNTO 2476 by using the Delivery System.

Open-Label Safety Run-in Phase: Treatment Group

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (8)

Unknown Facility

Arcadia, California, United States

Location

Unknown Facility

Chicago, Illinois, United States

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Unknown Facility

Lexington, Kentucky, United States

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Unknown Facility

Boston, Massachusetts, United States

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Unknown Facility

Royal Oak, Michigan, United States

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Unknown Facility

Cincinnati, Ohio, United States

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Unknown Facility

Philadelphia, Pennsylvania, United States

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Unknown Facility

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

Protocol Amendment 3 eliminated 2nd safety cohort and randomized masked portion of study per Sponsor decision to terminate development. Protocol specified follow-up visits were completed for treated participants, thus study was considered completed.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: January 20, 2016
• Study Start: December 4, 2015
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: April 29, 2025
• Results First Posted: June 23, 2020

Record last verified: 2025-04

Locations

US (8)