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

NCT00458575 | Terminated Phase 1 DMC

• 2 other identifiers: CR013210CNTO2476RPG1001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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 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).

Conditions

Retinitis Pigmentosa

Keywords

Retinitis Pigmentosa; Advanced retinitis pigmentosa (RP); CNTO 2476; Subretinal; Human umbilical tissue-derived cells (hUTC); Light perception (LP); Hand motion (HM)

Outcome Measures

Primary Outcomes (2)

• Number of adverse events as a measure of safety and tolerability

  Up to 5 years from the time participant is eligible to enter study

• 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

Secondary Outcomes (1)

• Change from baseline in retinal structure and visual function

  Up to 5 years from the time participant is eligible to enter study

Study Arms (1)

CNTO 2476

EXPERIMENTAL

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

Interventions

CNTO 2476 DRUG

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.

CNTO 2476

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other significant ophthalmologic diseases or any other ophthalmologic condition that interferes with ophthalmologic examination
• Women of childbearing potential
• Ocular hypertension
• Other serious medical conditions

Sponsors & Collaborators

• Centocor, Inc.: lead

Study Sites (3)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Southwest Portland, Oregon, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Related Publications (1)

• Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5.

  PMID: 30194931 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

US (3)