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
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00458575     History of Changes
Other Study ID Numbers: CR013210, CNTO2476RPG1001
Study First Received: April 10, 2007
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

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 Pigmentosa
Retinitis
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on October 01, 2014