A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa

Launched by NEUROTECH PHARMACEUTICALS · Mar 14, 2007

Keywords

ClinConnect Summary

This study will involve about 18 visits over 2½ years for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary effectiveness outcome for this study will be a visual field score one year after the implant surgery. There will be about 12 centers participating in this study, and up to 60 people enrolled, across the US. Each participant joining the study who has completed initial s...

Gender

ALL

Eligibility criteria

• Study inclusion / exclusion criteria:
• Criteria for patients to qualify for the study include, but are not limited to:
• • Over 18 years of age, and less than 65 years of age
• • Diagnosis of retinitis pigmentosa, Usher Syndrome Type 2 or 3 or Choroideremia
• • Visual acuity no worse than 20/63
• • Experience with at least two full threshold Humphrey Visual Field 30-2 tests, one completed within the year prior to enrolling in this study
• 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.