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

This study has been terminated.
(Internal Business Decision)
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00458575
First received: April 10, 2007
Last updated: June 25, 2014
Last verified: June 2014

April 10, 2007
June 25, 2014
April 2007
August 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Assesment of safety and patients' immune rejection throughout the trial
Complete list of historical versions of study NCT00458575 on ClinicalTrials.gov Archive Site
Change from baseline in retinal structure and visual function [ Time Frame: Up to 5 years from the time participant is eligible to enter study ] [ Designated as safety issue: No ]
This will be assessed by optical coherence tomography (OCT), fluorescein angiography (FA), fundus photography, and visual field sensitivity (FFST).
Evaluation of changes from baseline in retinal structure and visual function measured throughout the course of the trial.
Not Provided
Not Provided
 
A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa
A Phase I Open Label Non-comparative Study Evaluating the Safety of a Single, Unilateral, Subretinal Administration of CNTO 2476 in Advanced Retinitis Pigmentosa

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).

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).

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Retinitis Pigmentosa
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.
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.
Intervention: Drug: CNTO 2476
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00458575
CR013210, CNTO2476RPG1001
Yes
Centocor, Inc.
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP