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NCT00071227 · ClinicalTrials.gov registry record · Phase 1
Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00071227 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 16 participants.
The verdict
NCT00071227, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commercially available form of this drug is associated with potentially harmful side effects thought to be due to preservatives in the preparation. This study will use a formulation that does not contain these potentially harmful preservatives. Preliminary findings from other studies suggest that injection of steroids in the eye can reduce retinal thickening and improve vision. However, they may also cause mild discomfort and lead to vision-threatening conditions. The effects of the drug on the conditions under study in this protocol are not known. Patients with the following conditions involving disorders of retinal blood vessels may be eligible for this study: * Choroidal neovascularization associated with age-related macular degeneration (50 years of age and older) * Macular edema associated with retinal vein occlusion (18 years of age and older) * Diabetic macular edema ((18 years of age and older) Participants undergo the following tests and procedures: * Medical history and physical examination * Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be 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. * Indocyanine green angiography to identify feeder vessels that may be supplying abnormal blood vessels. This procedure is similar to fl
Interventions
- DRUG Triamcinolone Acetonide (TAC-PF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2003-10-15 |
| Est. Completion | 2007-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00071227
The ClinicalTrials.gov registry entry for NCT00071227 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 (TAC-PF) is the first listed.
NCT00071227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00071227 about?
NCT00071227 is a clinical study titled "Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders". This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commerc...
What is the current status of trial NCT00071227?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2003-10-15. Estimated completion is 2007-08-15.
What interventions are being tested in trial NCT00071227?
The interventions under investigation include: Triamcinolone Acetonide (TAC-PF) (DRUG).
Who is sponsoring clinical trial NCT00071227?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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