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:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00458575
First received: April 10, 2007
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

The main purpose of this study is to assess the effects (good and bad) of a therapy called CNTO 2476 for patients with advanced retinitis pigmentosa. Nine 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
Retinitis Pigmentosa
Drug: CNTO 2476
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:
  • Assessment of safety and patients' immune rejection throughout the trial

Secondary Outcome Measures:
  • Evaluation of changes from baseline in retinal structure and visual function measured throughout the course of the trial.

Enrollment: 7
Study Start Date: April 2007
Detailed Description:

CNTO 2476 is a type of therapy that may have beneficial effects on the retina in subjects with retinitis pigmentosa. This study will assess the safety of CNTO 2476 in patients with advanced retinitis pigmentosa. The study will also evaluate any changes in vision that might result from the injection of CNTO 2476. Nine patients with advanced retinitis pigmentosa will take part in this first study. There are two phases to this study: the main (acute) phase and the long-term safety follow-up phase. 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 phase. 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). Patient's will receive one dose of 100 microliters CNTO 2476 as an injection into the eye.

  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
  • patient 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458575

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00458575     History of Changes
Other Study ID Numbers: CR013210
Study First Received: April 10, 2007
Last Updated: April 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Retinitis Pigmentosa

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

ClinicalTrials.gov processed this record on May 16, 2013