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NCT01648452 · ClinicalTrials.gov registry record · Phase 1
CNTF Implants for CNGB3 Achromatopsia
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01648452 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT01648452, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: * Achromatopsia is an inherited condition that causes vision loss because cells in the retina do not work properly. It causes loss of acuity, sensitivity to light, and loss of color vision. There are no effective treatments for achromatopsia. * Four genes currently are known to cause achromatopsia. One of these, the cyclic nucleotide-gated channel beta 3 (CNGB3) gene, is the cause in about 50 percent of people. * CNTF is a natural chemical found in the body that promotes survival and function of nerve cells. CNTF has been shown to be effective in treating retinal disease in animals and can slow vision loss. * CNTF has also been studied in over 250 people with retinal disease other than achromatopsia. In these studies, a CNTF implant was placed into the eye during a simple surgery. The implant releases CNTF inside the eye, near the retina. These studies suggested that a CNTF implant might help vision in some eye diseases. Objectives: * To learn whether a CNTF implant is safe for people with CNGB3 achromatopsia. * To learn whether CNTF can improve visual acuity or color vision, and whether it may reduce sensitivity to light in people with CNGB3 achromatopsia. Eligibility: You may be able to take part in this study if you: * Are at least 18 years old. * Test positive for mutations in the CNGB3 gene and have no mutations in another achromatopsia gene. * Have 20/100 vision or worse in at least one eye. * Are not pregnant or nursing. Design: * To determine if you can take part, we will ask about your medical history and do a physical examination and an eye examination. Blood and urine samples will be taken. * This study requires 11 visits to the National Eye Institute over 3 years. * One visit will be for the implant surgery. The implant will be placed in one eye only. * Study visits will take place 1 day after implant surgery, and again 1 week later and 1 month, 3 months, 6 months, 1 year, 1.5 years and 3 years later. These visits will help us evaluat
Interventions
- BIOLOGICAL NT-501 CNTF-releasing implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01648452
The ClinicalTrials.gov registry entry for NCT01648452 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 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 NT-501 CNTF-releasing implant is the first listed.
NCT01648452 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01648452 about?
NCT01648452 is a clinical study titled "CNTF Implants for CNGB3 Achromatopsia". Background: * Achromatopsia is an inherited condition that causes vision loss because cells in the retina do not work properly. It causes loss of acuity, sensitivity to light, and loss of color vision. There are no effective treatments for achromatopsia. * Four genes currently are known to cause ac...
What is the current status of trial NCT01648452?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2012-07. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01648452?
The interventions under investigation include: NT-501 CNTF-releasing implant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01648452?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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