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NCT00069056 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Laser Photocoagulation Therapy for Diabetic Macular Edema
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00069056: Completed Phase 1 study, sponsored by National Eye Institute (NEI).
NCT00069056 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00069056, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 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 laser technique, the mild macular grid, uses lighter laser burns through the macula and may be less damaging to the eye, but this is not known. This study will compare the two techniques and the information on side effects will be used to design a larger study of whether one laser is more effective than the other. 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 levels, hemoglobin A1C (a measure of diabetes control), and creatinine (measure of 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 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 blo
Interventions
- PROCEDURE Laser Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2003-09-10 |
| Est. Completion | 2007-08-15 |
| Phase | Phase 1 |
What the finished NCT00069056 record still lists
NCT00069056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Laser Treatment is the first listed.
NCT00069056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00069056 about?
NCT00069056 is a clinical study titled "Pilot Study of Laser Photocoagulation Therapy for 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 ...
What is the current status of trial NCT00069056?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2003-09-10. Estimated completion is 2007-08-15.
What interventions are being tested in trial NCT00069056?
The interventions under investigation include: Laser Treatment (PROCEDURE).
Who is sponsoring clinical trial NCT00069056?
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 NCT00069056's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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