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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00447980
Other study ID # CNTF 4
Secondary ID
Status Completed
Phase Phase 2
First received March 9, 2007
Last updated November 15, 2016
Start date January 2007
Est. completion date July 2010

Study information

Verified date November 2016
Source Neurotech Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 one's 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. 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.


Description:

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 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 retinitis pigmentosa (RP).


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
NT-501
High Dose
NT-501
Low Dose

Locations

Country Name City State
United States Kellogg Eye Center Ann Arbor Michigan
United States Retina-Vitreous Associates Medical Group Beverly Hills California
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States Retina Foundation of Southwest Dallas Texas
United States The Hamilton Eye Institute Memphis Tennessee
United States Bascom Palmer Eye Insitute Miami Florida
United States University of Minnesota Minneapolis Minnesota
United States NY University Medical Center New York New York
United States Casey Eye Institue Portland Oregon
United States University of Califoria, Davis Sacramento California
United States University of Utah Salt Lake City Utah
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Neurotech Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Humphrey visual field sensitivity from baseline to month 12. 12 months No
Secondary Change in visual field sensitivity 24 months No
Secondary Mean, median and distribution of change in Best Corrected Visual Acuity 12 to 24 months No
Secondary Change in ERG 12 to 24 months No
Secondary Change in OCT 12 to 24 months No
Secondary Change in inflammation 12 to 24 months No
Secondary Change in vision-related quality of life 12 to 24 months No
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