Status:
TERMINATED
A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa
Lead Sponsor:
Centocor, Inc.
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
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 be...
Eligibility Criteria
Inclusion
- 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
- Other significant ophthalmologic diseases or any other ophthalmologic condition that interferes with ophthalmologic examination
- Women of childbearing potential
- Ocular hypertension
- Other serious medical conditions
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00458575
Start Date
April 1 2007
End Date
August 1 2013
Last Update
June 26 2014
Active Locations (3)
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1
Miami, Florida, United States
2
Southwest Portland, Oregon, United States
3
Dallas, Texas, United States