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NCT00063765 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Safety of Ciliary Neurotrophic Factor Implants in the Eye
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00063765 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 10 participants.
The verdict
NCT00063765, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will evaluate the safety of a ciliary neurotrophic factor (CNTF) implant placed in the eye to allow the release of CNTF directly on the retina. The results of this study may lead to a larger investigation of CNTF implants to treat retinitis pigmentosa (RP), a progressive degenerative eye disease that begins with loss of peripheral vision and night blindness and often leads to blindness in later life. Currently, there are no effective treatments for RP. Researchers have found, however, that certain proteins, called ciliary neurotrophic factor (CNTF), can partially protect cells in the eye if given directly inside the eye. A major challenge in treating RP is to deliver medicine directly into the eye. One way to ensure that CNTF gets into the eye is to surgically place an implant inside the eye to release the protein. Patients 18 years of age and older with retinitis pigmentosa whose visual acuity is 20/100 or worse may be eligible for this study. Candidates will be screened with a medical history, physical examination, eye examinations, and eye photographs. The eye examination includes measurement of visual acuity and eye pressure, examination of the pupils and eye movements, and examination of the lens and back of the eye. In addition, patients will have the following tests: * Visual field test: Patients look at a central spot on a white screen and tell the examiner whenever they see a small light appear at other places on the screen. * Electroretinogram (ERG): Electrodes are taped to the patient's forehead. Special contact lenses are placed on the eyes, similar to normal contact lenses, after the eye has been numbed with drops. The contact lenses sense small electrical signals generated by the retina. The ERG measures the electrical activity of the retina when it is stimulated by light. For the ERG recording, the patient looks inside a large, hollow, dark sphere, and sees flashes of light, first in the dark, and then with a light turned on in the spher
Interventions
- DRUG Ciliary Neurotrophic Factor Implant NT-501
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2003-06 |
| Est. Completion | 2006-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00063765
The ClinicalTrials.gov registry entry for NCT00063765 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ciliary Neurotrophic Factor Implant NT-501 is the first listed.
NCT00063765 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00063765 about?
NCT00063765 is a clinical study titled "Evaluation of Safety of Ciliary Neurotrophic Factor Implants in the Eye". This study will evaluate the safety of a ciliary neurotrophic factor (CNTF) implant placed in the eye to allow the release of CNTF directly on the retina. The results of this study may lead to a larger investigation of CNTF implants to treat retinitis pigmentosa (RP), a progressive degenerative eye ...
What is the current status of trial NCT00063765?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2003-06. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00063765?
The interventions under investigation include: Ciliary Neurotrophic Factor Implant NT-501 (DRUG).
Who is sponsoring clinical trial NCT00063765?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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