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CNTO 2476

Phase 1

Age-related Macular Degeneration | Monoclonal antibody | Ophthalmology |Johnson & Johnson|Last Updated: Aug 8, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

CNTO 2476 · 1 trial · 1 indication

Phase 1 1
NCT01226628A Safety Study of CNTO 2476 in Patients With Age-Related Macular DegenerationAge-related Macular Degeneration
COMPLETED39 Analytics
PHASE1COMPLETED
A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration
Age-related Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of eyes with serious ocular adverse events occurring over the first 12 months of the study
12 months

This number will be summarized descriptively for treated and fellow eyes within each dose level included in Phase 1 and Phase 2a portions of the study

Secondary Endpoints

Change from baseline in antibody peak values
Baseline (Screening), up to 60 months
Yearly rate of increase from baseline in area of Geographic Atrophy (GA)
Baseline (Screening), up to 60 months
Changes from baseline in visual function
Baseline (Screening), up to 60 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort AEXPERIMENTALPhase 1: 3 patients will receive 60,000 human umbilical tissue-derived cells (hUTC)
Cohort BEXPERIMENTALPhase 1: 3 patients will receive 120,000 hUTC
Cohort CEXPERIMENTALPhase 1: 3 patients will receive 300,000 hUTC
Cohort DEXPERIMENTALPhase 1: 3 patients will receive 560,000 hUTC
Cohort EEXPERIMENTALPhase 1: 6 patients will receive 300,000 hUTC
Cohort FEXPERIMENTALPhase 1: 6 patients will receive either 60,000 or 300,000 hUTC
Cohort GEXPERIMENTALPhase 1: 6 patients will receive either 60,000 or 300,000 hUTC
Phase 2aEXPERIMENTALUp to 38 patients will receive one of two optimal doses as selected from the Phase 1 portion of the study

Interventions

NameTypeDescription
CNTO 2476BIOLOGICAL -
iTrack Model 275 micro catheterPROCEDURECNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment. During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Women must be incapable of childbearing * Patient must be 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 * Confirmed diagnosis of bilatera...

Countries:United States
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Frequently asked questions about CNTO 2476

What is CNTO 2476 used for?

CNTO 2476 is an investigational monoclonal antibody being studied for the treatment of age-related macular degeneration, a condition that affects the central part of the retina and can lead to vision loss. It is currently in clinical development for this ophthalmologic indication.

What does CNTO 2476 target?

CNTO 2476 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential role in treating age-related macular degeneration, though the exact mechanism of action is not publicly detailed.

Who makes CNTO 2476?

CNTO 2476 is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.

What phase is CNTO 2476 in?

CNTO 2476 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical evaluation for age-related macular degeneration.

What clinical trials is CNTO 2476 in?

CNTO 2476 has been studied in one clinical trial, identified as NCT01226628, titled "A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration." This Phase 1 study was completed and enrolled 39 participants in the United States.

Is CNTO 2476 the same as any other drug?

CNTO 2476 is an investigational drug and no alternative names have been reported in clinical trial records. It is distinct from other approved therapies for age-related macular degeneration, and its development is being conducted under this specific compound identifier.