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| Sponsored by: |
Neurotech Pharmaceuticals |
|---|---|
| Information provided by: | Neurotech Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00447993 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Retinitis Pigmentosa |
Drug: NT-501 |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| 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 Acuity as the Primary Outcome |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Criteria for patients to qualify for the study include, but are not limited to:
Exclusion Criteria:
The following criteria will exclude patients from the study:
Contacts and Locations| United States, California | |
| Retina-Vitreous Associates Medical Group | |
| Beverly Hills, California, United States, 90211 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143-0730 | |
| University of Califoria, Davis | |
| Sacramento, California, United States, 95817 | |
| United States, Florida | |
| Retina Group of Florida | |
| Hollywood, Florida, United States, 33021-6746 | |
| University of Florida | |
| Jacksonville, Florida, United States, 32216-1480 | |
| United States, Massachusetts | |
| Ophthalmic Consultants of Boston | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Kellogg Eye Center | |
| Ann Arbor, Michigan, United States, 48105 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455-0501 | |
| United States, New York | |
| NY University Medical Center | |
| New York, New York, United States, 10016 | |
| United States, Oregon | |
| Casey Eye Institue | |
| Portland, Oregon, United States, 97239-4197 | |
| United States, Tennessee | |
| The Hamilton Eye Institute | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| Retina Foundation of Southwest | |
| Dallas, Texas, United States, 75231 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| Study Director: | Weng Tao, M.D., PhD | Neurotech Pharmaceuticals |
More Information
| Study ID Numbers: | CNTF 3 |
| Study First Received: | March 9, 2007 |
| Last Updated: | October 29, 2007 |
| ClinicalTrials.gov Identifier: | NCT00447993 |
| Health Authority: | United States: Food and Drug Administration |
|
Retinitis Pigmentosa eye disease retinal disorder CNTF |
|
Pigmentary retinopathy Genetic Diseases, Inborn Eye Diseases Cone rod dystrophy Retinitis Pigmentosa |
Retinitis Retinal Degeneration Eye Diseases, Hereditary Retinal Diseases Retinal degeneration |
