A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa
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|ClinicalTrials.gov Identifier: NCT00458575|
Recruitment Status : Terminated (Internal Business Decision)
First Posted : April 11, 2007
Last Update Posted : June 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Drug: CNTO 2476||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
- 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 ]
- 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 ]
- Change from baseline in retinal structure and visual function [ Time Frame: Up to 5 years from the time participant is eligible to enter study ]This will be assessed by optical coherence tomography (OCT), fluorescein angiography (FA), fundus photography, and visual field sensitivity (FFST).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458575
|United States, Florida|
|Miami, Florida, United States|
|United States, Oregon|
|Sw Portland, Oregon, United States|
|United States, Texas|
|Dallas, Texas, United States|
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|