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NCT00457067 · ClinicalTrials.gov registry record · Phase 1
Injected Ranibizumab to Treat Macular Telangiectasia With New Blood Vessel Formation
A Phase 1 study of Telangiectasia, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00457067 is a Phase 1 study of Telangiectasia that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00457067, a Phase 1 study of Telangiectasia, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
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 new vessels forming under the retina. Patients 18 years of age and older who have macular telangiectasia in both eyes and new blood vessel formation under the retina in at least one eye 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 light shined into t
Conditions Studied
Interventions
- DRUG Ranibizumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-03-27 |
| Est. Completion | 2007-10-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00457067
The ClinicalTrials.gov registry entry for NCT00457067 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 1 condition, with Telangiectasia appearing as the primary indexed condition, and to 1 intervention - of which Ranibizumab is the first listed.
NCT00457067 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00457067 about?
NCT00457067 is a clinical study titled "Injected Ranibizumab to Treat Macular Telangiectasia With 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 NCT00457067?
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 conditions does trial NCT00457067 study?
This clinical trial studies the following conditions: Telangiectasia.
What interventions are being tested in trial NCT00457067?
The interventions under investigation include: Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT00457067?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00457067 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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