A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00458575
• Other study ID #: CR013210
• Secondary ID: CNTO2476RPG1001
• Status: Terminated
• Phase: Phase 1
• First received: April 10, 2007
• Last updated: June 25, 2014
• Start date: April 2007
• Est. completion date: August 2013

Study information

• Verified date: June 2014
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events as a measure of safety and tolerability		Up to 5 years from the time participant is eligible to enter study	Yes
Primary	Level of anti-CNTO 2476 antibody in blood for immunogenicity testing		Baseline, Days 7 and 15, Weeks 3 and 4, Months 2, 3, 6, 12, 24, 36, 48, and 60	No
Secondary	Change from baseline in retinal structure and visual function	This will be assessed by optical coherence tomography (OCT), fluorescein angiography (FA), fundus photography, and visual field sensitivity (FFST).	Up to 5 years from the time participant is eligible to enter study	No