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A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa

This study has been terminated.
(Internal Business Decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00458575
First Posted: April 11, 2007
Last Update Posted: June 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centocor, Inc.
  Purpose
The main purpose of this study is to evaluate the preliminary safety and immunogenicity (ability of an antigen to provoke immune response in the human body) of CNTO 2476, administered subretinally, in participants with advanced retinitis pigmentosa (RP; disease of the eye that leads to loss of vision and blindness) with either light perception only (LP) or hand motion (HM).

Condition Intervention Phase
Retinitis Pigmentosa Drug: CNTO 2476 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open Label Non-comparative Study Evaluating the Safety of a Single, Unilateral, Subretinal Administration of CNTO 2476 in Advanced Retinitis Pigmentosa

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Number of adverse events as a measure of safety and tolerability [ Time Frame: Up to 5 years from the time participant is eligible to enter study ]
  • Level of anti-CNTO 2476 antibody in blood for immunogenicity testing [ Time Frame: Baseline, Days 7 and 15, Weeks 3 and 4, Months 2, 3, 6, 12, 24, 36, 48, and 60 ]

Secondary Outcome Measures:
  • Change from baseline in retinal structure and visual function [ Time Frame: Up to 5 years from the time participant is eligible to enter study ]
    This will be assessed by optical coherence tomography (OCT), fluorescein angiography (FA), fundus photography, and visual field sensitivity (FFST).


Enrollment: 7
Study Start Date: April 2007
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNTO 2476
Participants 1 to 4: advanced retinitis pigmentosa (RP) with light perception only (LP); Participant 5: combination visual acuity of LP in the treated eye and no better than hand motion (HM) in the fellow eye; and Participants 6 to 9: advanced RP with hand motion (HM) will receive different dose levels of CNTO 2476.
Drug: CNTO 2476
Participant 1 will receive 5.6x100000; Participants 2, 3, 5, 6, and 7 will receive 6.0x10000; Participant 4 will receive 3.0x100000; and Participants 8 and 9 will receive 1.2x100000 of CNTO 2476 as a single dose of viable cells in phosphate buffered saline (PBS) in a total volume of 100 μL injected subretinally.

Detailed Description:
The study will be an open-label (all people know the identity of the intervention), first in human safety study. Nine adult men and women with advanced RP with LP only (first 5 participants) or not better than HM bilaterally (subsequent 4 participants) in both eyes will be enrolled. Participant 5 may have combination visual acuity of LP in the treated eye and no better than HM in the fellow eye. Treatment will proceed on a cohort basis ie, Cohort I: Participant 1; Cohort II: Participant 2; Cohort III: Participant 3 and 4; Cohort IV: Participant 5, 6, and 7; and Cohort V: Participant 8 and 9. The initial participants for each cohort must have completed at least 4 weeks of post-treatment follow-up before participants in the next cohort may be treated. There are 2 safety assessment phases in this study: the main phase approximately 12 months from the time the participant is eligible to enter the study and the long-term safety follow-up phase of 4 additional years. The total length of the participation in the study could last up to 5 years (including both the main and safety follow-up phases).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of retinitis pigmentosa that is not part of another systemic disease
  • Vision deficit characterized by vision that is not better than either light perception (Group 1) or hand motion (Group 2) in both eyes
  • Normal hematology and chemistry lab results
  • Participant is suitable candidate for ophthalmologic surgery

Exclusion Criteria:

  • Other significant ophthalmologic diseases or any other ophthalmologic condition that interferes with ophthalmologic examination
  • Women of childbearing potential
  • Ocular hypertension
  • Other serious medical conditions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458575


Locations
United States, Florida
Miami, Florida, United States
United States, Oregon
Sw Portland, Oregon, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00458575     History of Changes
Other Study ID Numbers: CR013210
CNTO2476RPG1001 ( Other Identifier: Centocor, Inc )
First Submitted: April 10, 2007
First Posted: April 11, 2007
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Centocor, Inc.:
Retinitis Pigmentosa
Advanced retinitis pigmentosa (RP)
CNTO 2476
Subretinal
Human umbilical tissue-derived cells (hUTC)
Light perception (LP)
Hand motion (HM)

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn


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