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

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.

Criteria

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