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NCT00106132 · ClinicalTrials.gov registry record · Phase 3
Steroid Injections vs. Standard Treatment for Macular Edema Due to Retinal Blood Vessel Blockage
A Phase 3 study of Macular Edema and Retinal Vein Occlusion, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,260
- Enrollment target
- 1
- Study location
NCT00106132 is a Phase 3 study of Macular Edema and Retinal Vein Occlusion that has completed, run by National Eye Institute (NEI). The registered enrollment target is 1,260 participants, above the 90-participant average among 14 other Macular Edema trials with a reported enrollment target (1300% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00106132, a Phase 3 study of Macular Edema and Retinal Vein Occlusion, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,260 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will compare the safety and effectiveness of two treatments-injections of triamcinolone acetonide into the eye vs. standard laser therapy-for macular edema (swelling in the center of the retina) that is caused by blockage in a retinal blood vessel. Edema caused by blockage in a large vessel is called central retinal vein occlusion (CRVO). Edema caused by blockage in a smaller vein is called branch retinal vein occlusion (BRVO). Triamcinolone acetonide is a steroid drug that reduces swelling; the Food and Drug Administration has approved it for injection into joints and muscles to treat inflammatory conditions. Patients 18 years of age and older with macular edema due to CRVO or BRVO of between 3 and 18 months' duration may be eligible for this study. Candidates are screened with a medical history, blood pressure measurement, and urine pregnancy test for women who can become pregnant. Screening also includes the following procedures: * Eye examination to assess visual acuity and eye pressure, and to examine the cornea, lens, and retina. The pupils are dilated with drops for this examination. * Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. * Optical coherence tomography to measure retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. The patient is seated in front of a machine and looks at a pattern of flashing and rotating red and green lights, first with one eye and then with the other. * Fundus photography to help evaluate the status of the retina and changes that may occur in the future. Photographs of the retina are taken using a camera that flashes a bright light into the eye. Participants
Conditions Studied
Interventions
- DRUG Triamcinolone Acetonide
Study Locations (1)
Maryland
- National Eye Institute (NEI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,260 participants |
| Start Date | 2005-03 |
| Est. Completion | 2005-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106132
The ClinicalTrials.gov registry entry for NCT00106132 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,260 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 90-participant average among 14 other Macular Edema trials with a reported enrollment target (1300% higher). The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which Triamcinolone Acetonide is the first listed.
NCT00106132 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00106132 about?
NCT00106132 is a clinical study titled "Steroid Injections vs. Standard Treatment for Macular Edema Due to Retinal Blood Vessel Blockage". This study will compare the safety and effectiveness of two treatments-injections of triamcinolone acetonide into the eye vs. standard laser therapy-for macular edema (swelling in the center of the retina) that is caused by blockage in a retinal blood vessel. Edema caused by blockage in a large vess...
What is the current status of trial NCT00106132?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,260 participants. The study started on 2005-03. Estimated completion is 2005-11.
What conditions does trial NCT00106132 study?
This clinical trial studies the following conditions: Macular Edema, Retinal Vein Occlusion, Macular Edema, Cystoid.
What interventions are being tested in trial NCT00106132?
The interventions under investigation include: Triamcinolone Acetonide (DRUG).
Who is sponsoring clinical trial NCT00106132?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00106132 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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