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NCT00685854 · ClinicalTrials.gov registry record · Phase 1
Ranibizumab Injections to Treat Macular Telangiectasia Without New Blood Vessel Growth
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00685854 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT00685854, 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 (Lucentis) can help prevent vision loss in people with macular telangiectasia, a condition in which new blood vessels grow in the retina at the back of the eye and can leak. Such changes in blood vessels are seen in other diseases associated with changes in a body chemical called vascular endothelial growth factor (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease, age-related macular degeneration, with similar changes in eye blood vessels. People 18 years of age and older with macular telangiectasia in both eyes with no new blood vessel growth in either eye may be eligible for this study. They must have vision better than 20/400 in the study eye. Participants undergo the following procedures: * Ranibizumab injections in the study eye at least four times over 12 weeks. Depending on the response to treatment and the side effects, additional injections may be given every 4 weeks for up to 1 year. The eye is numbed before the injection and the eye area is cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection to prevent infection. * Evaluations before starting treatment, at the time of each injection, and 8 weeks after the last treatment: * History and physical examination. * Eye examination with dilation, microperimetry and photography: The eye examination measures visual acuity, eye pressure and eye movements. For the microperimetry test, subjects sit in front of a computer screen and press a button when they see a light on the screen. Measurements and photographs of the retina are also taken. * Fluorescein and indocyanine green angiography to examine the blood vessels in the eye: A dye called fluorescein or indocyanine green is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels. * Pregnancy test: Women who ar
Interventions
- DRUG Ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2008-05-21 |
| Est. Completion | 2011-03-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00685854
The ClinicalTrials.gov registry entry for NCT00685854 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.
NCT00685854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00685854 about?
NCT00685854 is a clinical study titled "Ranibizumab Injections to Treat Macular Telangiectasia Without New Blood Vessel Growth". This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss in people with macular telangiectasia, a condition in which new blood vessels grow in the retina at the back of the eye and can leak. Such changes in blood vessels are seen in other diseases associated with ...
What is the current status of trial NCT00685854?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2008-05-21. Estimated completion is 2011-03-24.
What interventions are being tested in trial NCT00685854?
The interventions under investigation include: Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT00685854?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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