A Study of Encapsulated Cell Technology (ECT) Implant for Patients With Late Stage Retinitis Pigmentosa

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to look at the safety and effectiveness of CNTF implants on vision in persons with retinitis pigmentosa, Usher type II & III, and Choroideremia. This research is being done because there are no effective therapies for people with these retinal degenerations. They are genetic disorders that affect our ability to see at night, and later cause tunnel vision and loss of central vision. Retinal degenerations affect the retina, a light sensitive layer of cells in the back of the eye. Slowly over time, these cells die and cause permanent loss of vision.

The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF and release it through the capsule membrane into the surrounding fluid. This study will look at the effect of the implant on vision loss by retinitis pigmentosa, Usher type II & III, and Choroideremia. In this study, two different CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (or placebo) surgery in the other eye.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurotech Pharmaceuticals

Criteria

Inclusion Criteria:

Criteria for patients to qualify for the study include, but are not limited to:

• Over 18 years of age, and less than 68 years of age

• Diagnosis of retinitis pigmentosa, Usher Syndrome Type 2 or 3 or Choroideremia

• Visual acuity no better than 20/63 and no worse than 20/320

• Reduced electrical responses from the retina (ERG) and loss of peripheral vision

Exclusion Criteria:

The following criteria will exclude patients from the study:

• Pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception.

• Retinitis pigmentosa caused by a classic syndrome, including Usher Type I

• Other eye diseases including advanced cataract.

• Chronic systemic disease requiring continuous treatment with systemic steroids, immunosuppressive medications or insulin.