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NCT01441102 · ClinicalTrials.gov registry record · Phase 1
Dextromethorphan for Diabetic Macular Edema
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01441102 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 7 participants.
The verdict
NCT01441102, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema. Objectives: To see if dextromethorphan can help treat diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: * This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours. * Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing. * Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken. * Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests. * Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.
Interventions
- DRUG Dextromethorphan hydrobromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01441102
The ClinicalTrials.gov registry entry for NCT01441102 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 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 Dextromethorphan hydrobromide is the first listed.
NCT01441102 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01441102 about?
NCT01441102 is a clinical study titled "Dextromethorphan for Diabetic Macular Edema". Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan i...
What is the current status of trial NCT01441102?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2011-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01441102?
The interventions under investigation include: Dextromethorphan hydrobromide (DRUG).
Who is sponsoring clinical trial NCT01441102?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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