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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00458575 |
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Date of registration:
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10/04/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa
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Scientific title:
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A Phase I Open Label Non-comparative Study Evaluating the Safety of a Single, Unilateral, Subretinal Administration of CNTO 2476 in Advanced Retinitis Pigmentosa |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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7 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00458575 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Centocor, Inc. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centocor, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa
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Intervention(s)
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Drug: CNTO 2476
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Primary Outcome(s)
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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]
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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]
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Secondary Outcome(s)
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Change from baseline in retinal structure and visual function
[Time Frame: Up to 5 years from the time participant is eligible to enter study]
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Secondary ID(s)
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CR013210
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CNTO2476RPG1001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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