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NCT00105404 · ClinicalTrials.gov registry record · Phase 3
Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation
A Phase 3 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT00105404 is a Phase 3 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT00105404, a Phase 3 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study will compare the side effects of two treatments for diabetic macular edema, in which blood vessels in the retina (tissue that lines the back of the eye) become leaky and the retina and macula (the center part of the retina that is responsible for fine vision) swell, causing vision loss. Patients 18 years of age and older with diabetes mellitus and macular edema in one or both eyes may be eligible for this study. Candidates are screened with the following tests and procedures: * Blood pressure measurement. * Blood tests to measure HbA1c, a measure of the patient's diabetes control. * Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils are dilated with drops for this examination. * Eye photography to help evaluate the status of the retina and changes that may occur in the future. Photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye. * Electroretinograms (ERG) to measure electrical responses generated in the retina. Wearing eye patches, the patient sits in a dark room for 30 minutes. Then, electrodes are taped to the forehead and an earlobe. The eye patches are removed, the surface of the eye is numbed with eye drops, and contact lenses are placed on the eyes. The patient looks inside a white globe that emits a series of light flashes for about 20 minutes. The contact lenses sense small electrical signals generated by the retina when the light flashes. * Optical coherence tomography to measure retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine whether retinal thickening is improving, worsening, or staying the same. Patients with macular edema in both eyes receive laser therapy in one eye and triamcinolone injections in the other. Patients with just one affected eye are randomly assigned to receive either laser or triam
Interventions
- DRUG Triamcinolone Acetonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2005-03-09 |
| Est. Completion | 2006-10-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00105404
The ClinicalTrials.gov registry entry for NCT00105404 describes a study currently listed as completed, categorized as Phase 3. 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 Triamcinolone Acetonide is the first listed.
NCT00105404 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00105404 about?
NCT00105404 is a clinical study titled "Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation". This study will compare the side effects of two treatments for diabetic macular edema, in which blood vessels in the retina (tissue that lines the back of the eye) become leaky and the retina and macula (the center part of the retina that is responsible for fine vision) swell, causing vision loss. ...
What is the current status of trial NCT00105404?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2005-03-09. Estimated completion is 2006-10-30.
What interventions are being tested in trial NCT00105404?
The interventions under investigation include: Triamcinolone Acetonide (DRUG).
Who is sponsoring clinical trial NCT00105404?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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