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CNTO 2476 3.0 x 10^5 cells

Phase 2

Visual Acuity | Small molecule | Ophthalmology |Johnson & Johnson|Last Updated: Apr 29, 2025

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

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Clinical trial landscape

CNTO 2476 3.0 x 10^5 cells · 1 trial · 3 indications

Phase 2 1
NCT02659098A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic AtrophyVisual Acuity
COMPLETED21 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy
Visual Acuity
NCT0265909821
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Study Endpoints

Primary Endpoints

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open-Label Safety Run-in Phase: Treatment GroupEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
CNTO 2476 3.0 x 10^5 cellsDRUGParticipants will receive a single subretinal administration of CNTO 2476 3.0 x 10\^5 cells in 50 microliter (mcL) given by subretinal Delivery System.
Subretinal Delivery SystemDEVICEParticipants will receive CNTO 2476 by using the Delivery System.
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Eligibility Criteria

Age Range55 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites8

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 Treat...

Countries:United States
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Frequently asked questions about CNTO 2476 3.0 x 10^5 cells

What is CNTO 2476 3.0 x 10^5 cells used for?

CNTO 2476 3.0 x 10^5 cells is an investigational small molecule being studied for use in ophthalmology, specifically for visual acuity in patients with geographic atrophy and macular degeneration. It is administered via subretinal injection and is currently in Phase 2 clinical development.

What does CNTO 2476 3.0 x 10^5 cells target?

The specific molecular target of CNTO 2476 3.0 x 10^5 cells is not disclosed in available information. It is a small molecule being evaluated for its safety and clinical response in treating geographic atrophy, a condition associated with macular degeneration that affects visual acuity.

Who makes CNTO 2476 3.0 x 10^5 cells?

CNTO 2476 3.0 x 10^5 cells is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The drug is currently in Phase 2 clinical trials for the treatment of geographic atrophy.

What phase is CNTO 2476 3.0 x 10^5 cells in?

CNTO 2476 3.0 x 10^5 cells is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with geographic atrophy.

What clinical trials is CNTO 2476 3.0 x 10^5 cells in?

CNTO 2476 3.0 x 10^5 cells has been studied in one completed Phase 2 trial, identified as NCT02659098. This trial evaluated the safety and clinical response of subretinal administration of the drug in 21 participants with geographic atrophy in the United States.

Is CNTO 2476 3.0 x 10^5 cells the same as CNTO 2476?

CNTO 2476 3.0 x 10^5 cells is a specific dose formulation of CNTO 2476, referring to a cell count of 300,000 cells. The drug is being developed by Johnson & Johnson for the treatment of geographic atrophy and is currently in Phase 2 clinical trials.