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NCT00457145 · ClinicalTrials.gov registry record · Phase 1
Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00457145 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT00457145, 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
This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form under the retina. Both the existing dilated vessels, as well the new subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This study will see if ranibizumab can slow or stop the leakage and growth of existing, dilated, macular vessels in cases where new vessel formation under the retina is absent. Patients 18 years of age and older who have macular telangiectasia without new blood vessel formation may be eligible for this study. Visual acuity must be 20/40 or worse. Participants receive at least four injections of ranibizumab into the eye over a 12-week period. After the fourth injection, additional injections may be given every 4 weeks for up to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab treatment, patients undergo the following procedures: * Medical history and physical examination. * Eye examination, including dilation of the pupils and measurement of the fluid pressure in the eye. * Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Photographs of the retina are taken with a special camera that flashes a blue light into the eye. The photos show whether any dye has leaked from the vessels into the retina. * Indocyanine green angiography: This procedure identifies feeder vessels that may be supplying the abnormal blood vessels. The test is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. * Autofluorescence imaging: This test examines how well the retina functions. The back of the eye is photographed with a bright light. * Optical coherence tomography: This test measures retinal thickness. A ligh
Interventions
- DRUG Ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-03-27 |
| Est. Completion | 2007-10-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00457145
The ClinicalTrials.gov registry entry for NCT00457145 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 Ranibizumab is the first listed.
NCT00457145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00457145 about?
NCT00457145 is a clinical study titled "Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation". This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form u...
What is the current status of trial NCT00457145?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2007-03-27. Estimated completion is 2007-10-24.
What interventions are being tested in trial NCT00457145?
The interventions under investigation include: Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT00457145?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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