Clinical Trial: A Study of Encapsulated Cell Technology (ECT) Implant for Patients With Late Stage Retinitis Pigmentosa
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II/III Study of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor (CNTF) for Participants With Retinitis Pigmentosa Using Visual Acuit
Brief 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.
Detailed Summary: This study will involve about 16 visits over 1½ 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 acuity score one year after the implant surgery. There will be about 13 centers participating in this study, and up to 60 people enrolled across the US. Each participant joining the study who has completed initial screening will then be scheduled to have a brief surgical procedure performed on each eye, one of which will include a very small cell-filled implant. Follow-up visits for repeat assessments will be required regularly to determine if the implant being tested is safe and effective for use to treat RP.
Sponsor: Neurotech Pharmaceuticals
Current Primary Outcome: The primary outcome is the change in best-corrected visual acuity (BCVA) using the Electronic Visual Acuity (EVA) technology at month 12. [ Time Frame: 12 months ]
Original Primary Outcome: The primary outcome is the change in best-corrected visual acuity (BCVA) using the Electronic Visual Acuity (EVA) technology at month 12.
Current Secondary Outcome: Longer-term observations of change in visual acuity, disease modification, BCVA, ERG, optical coherence tomography, inflammation, and vision-related quality of life(NEI-VFQ25). [ Time Frame: 18 months ]
Original Secondary Outcome: Longer-term observations of change in visual acuity, disease modification, BCVA, ERG, optical coherence tomography, inflammation, and vision-related quality of life(NEI-VFQ25).
Information By: Neurotech Pharmaceuticals
Dates:
Date Received: March 9, 2007
Date Started: January 2007
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016
