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NCT00231023 · ClinicalTrials.gov registry record · Phase 2
Triamcinolone Acetonide Injections to Treat Diabetic Macular Edema
A Phase 2 study of Diabetic Retinopathy, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00231023: Completed Phase 2 study of Diabetic Retinopathy, sponsored by National Eye Institute (NEI).
NCT00231023 is a Phase 2 study of Diabetic Retinopathy that has completed, run by National Eye Institute (NEI). The registered enrollment target is 10 participants, below the 1,676-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00231023, a Phase 2 study of Diabetic Retinopathy, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate which of the three following treatment options is better for diabetic macular edema: laser alone, steroid injection alone, or steroid injection followed by laser. Macular edema is a swelling in the small central part of the retina - the part of the retina that is used for sharp, straight-ahead vision. Laser treatment is the only treatment that has been proven to be beneficial for diabetic macular edema. It reduces the swelling and lessens the chance of further vision loss, but it does not improve vision. Triamcinolone is a steroid drug that decreases inflammation and scarring. Injections of the drug have decreased macular edema in some patients and improved vision. Swelling may return, requiring repeat injections, and it is not known if the vision improvement is permanent. This 3-year study will examine and compare the benefits and side effects of both treatments, alone and in combination. Patients 18 years of age and older with diabetic macular edema may be eligible for this study. Participants undergo the following tests and procedures. At the beginning of the study: * Blood tests to measure HbA1C (measure of diabetes control). * Measurement of blood pressure. * Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils are dilated with drops for this examination. * Optical coherence tomography (OCT) to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. Photographs of the retina and lens. A special camera with bright flashes is used to take these photographs. Treatments Some patients will have one eye treated and some patients will have both eyes treated. The treatment for a given individual is determined by chance: * Triamcinolone acetonide injection alon
Conditions Studied
Interventions
- DRUG Peribulbar Triamcinolone Acetonide
Study Locations (1)
Maryland
- National Eye Institute (NEI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2005-09 |
| Est. Completion | 2006-05 |
| Phase | Phase 2 |
What the finished NCT00231023 record still lists
NCT00231023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,676-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetic Retinopathy appearing as the primary indexed condition, and to 1 intervention - of which Peribulbar Triamcinolone Acetonide is the first listed.
NCT00231023 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00231023 about?
NCT00231023 is a clinical study titled "Triamcinolone Acetonide Injections to Treat Diabetic Macular Edema". This study will evaluate which of the three following treatment options is better for diabetic macular edema: laser alone, steroid injection alone, or steroid injection followed by laser. Macular edema is a swelling in the small central part of the retina - the part of the retina that is used for sh...
What is the current status of trial NCT00231023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2005-09. Estimated completion is 2006-05.
What conditions does trial NCT00231023 study?
This clinical trial studies the following conditions: Diabetic Retinopathy.
What interventions are being tested in trial NCT00231023?
The interventions under investigation include: Peribulbar Triamcinolone Acetonide (DRUG).
Who is sponsoring clinical trial NCT00231023?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00231023 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00231023's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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