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NCT00055042 · ClinicalTrials.gov registry record · Phase 1
Laser and Antioxidant Treatment of Diabetic Macular Edema
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00055042: Completed Phase 1 study, sponsored by National Eye Institute (NEI).
NCT00055042 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00055042, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes. In macular edema, blood vessels in the retina-a thin layer of tissue that lines the back of the eye-become leaky and the retina swells. The macula-the center part of the retina that is responsible for fine vision-may also swell and cause vision loss. Traditional laser treatment (argon blue or green, or yellow) for macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision. A different type of laser (diode) may have less damaging effects to the eye and fewer long-term adverse effects, but this is not known. The results of this study on side effects of the treatments will be used to design a larger study of effectiveness. The study will also examine whether vitamin E can reduce the damage caused by laser treatment. Patients with elevated cholesterol levels will be invited to participate in a cholesterol reduction part of the study to compare normal-pace cholesterol reduction with accelerated reduction. Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be eligible for this study. Candidates will be screened with 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. * Blood tests to measure cholesterol and vitamin E blood levels, blood clotting time, hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney function. * Eye photography to help evaluate the status of the retina and changes that may occur in the future. Special photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye. * Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected int
Interventions
- DRUG Vitamin E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2003-02 |
| Est. Completion | 2004-01 |
| Phase | Phase 1 |
What the finished NCT00055042 record still lists
NCT00055042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin E is the first listed.
NCT00055042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00055042 about?
NCT00055042 is a clinical study titled "Laser and Antioxidant Treatment of Diabetic Macular Edema". This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes. In macular edema, blood vessels in the retina-a thin layer of tissue that lines the back of the eye-become leaky and the retina swells. The macula-the center par...
What is the current status of trial NCT00055042?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2003-02. Estimated completion is 2004-01.
What interventions are being tested in trial NCT00055042?
The interventions under investigation include: Vitamin E (DRUG).
Who is sponsoring clinical trial NCT00055042?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00055042's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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