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Triamcinolone Acetonide Injections to Treat Diabetic Macular Edema
NCT00231023 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00231023
The ClinicalTrials.gov registry entry for NCT00231023 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 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 214 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00231023 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00231023?
The interventions under investigation include: Peribulbar Triamcinolone Acetonide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00231023?
This trial is sponsored by National Eye Institute (NEI), which has 214 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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