A Study of the Safety and Efficacy of CNTO2476 in Patients With Age-related Macular Degeneration - Full Text View

Sponsor:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT01226628

Purpose

The main purpose of this study is to assess the effects (good and bad) of a therapy called CNTO 2476 for patients with age related macular degeneration. Patients will have CNTO 2476 injected by the surgeon into the subretinal space in the back of one of their eyes. The patients will then be assessed over a period of at least one year by their surgeon.

Condition	Intervention	Phase
Macular Degeneration	Biological: CNTO 2476	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 1/2a, Multicenter, Randomized, Dose Escalation, Fellow-Eye Controlled Study Evaluating the Safety and Clinical Response of a Single, Subretinal Administration of Human Umbilical Tissue-Derived Cells (CNTO 2476) in Subjects With Visual Acuity Impairment Associated With the Geographic Atrophy Se

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

Safety and Tolerability of CNTO 2476 [ Time Frame: Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Selection of 2 doses of CNTO 2476 [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
Clinical response of CNTO 2476 [ Time Frame: Year 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	September 2010
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 CNTO 2476 50 microliters Dose 1 CNTO 2476	Biological: CNTO 2476 50 microliters Dose 1 CNTO 2476
Experimental: 002 CNTO 2476 50 microliters Dose 2 CNTO 2476	Biological: CNTO 2476 50 microliters Dose 2 CNTO 2476
Experimental: 003 CNTO 2476 50 microliters Dose 3 CNTO 2476	Biological: CNTO 2476 50 microliters Dose 3 CNTO 2476
Experimental: 004 CNTO 2476 50 microliters Dose 4 CNTO 2476	Biological: CNTO 2476 50 microliters Dose 4 CNTO 2476

Detailed Description:

This study will assess the safety of CNTO 2476 in patients with age related macular degeneration. The study will also evaluate any changes in vision that might result from the injection of CNTO 2476.

The study will be conducted in 2 portions: the Phase 1 portion will include dose escalation and the Phase 2 portion will enroll additional subjects randomized to one of the 2 optimal doses selected from the Phase 1 portion.

Patient participation in the main phase of the study will last approximately 12 months from the time the patient is eligible to enter the study. During the main part of the study, the patient will have a screening (or baseline visit) and if the patient is eligible for the study, the patient's doctor will then schedule the procedure for the treatment. The patient will be asked to return to the clinic approximately 4 times in the first month after the treatment (Days 1, 7 and 15 and Week 4 post-treatment). Thereafter, the visits become less frequent at Months 3, 6 and 12 post-treatment. The long-term safety follow-up phase of the trial will begin after the patient completes the main phase of the study and will last approximately 4 additional years. The clinic visits during the safety follow-up stage are only twice per year for that stage. The total length of the patient's participation in the trial could last up to 5 years (including both the main and safety follow-up phases). Patients will receive one dose of 50 microliters CNTO 2476 as an injection into the eye. Safety evaluations will be completed throughout the study including laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events. A single dose of 50 microliters CNTO 2476 cells

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women must be incapable of childbearing
Patient 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
Confirmed diagnosis of bilateral geographic atrophy (GA) of the macula bilaterally caused by age-related macular degeneration

Exclusion Criteria:

Evidence of other significant ophthalmologic disease
Ocular hypertension
Previous cell therapy other than blood components

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226628

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

JNJ.CT@sylogent.com

Locations

United States, California
	Recruiting
Arcadia, California, United States
United States, Pennsylvania
	Recruiting
Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sr. Director, Centocor
ClinicalTrials.gov Identifier:	NCT01226628 History of Changes
Other Study ID Numbers:	CR017548, CNTO2476MDG1002
Study First Received:	October 21, 2010
Last Updated:	January 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

cell therapy
macular degeneration
CNTO 2476

Additional relevant MeSH terms:

Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 21, 2012