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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: Completed Phase 1 study, sponsored by National Eye Institute (NEI).
NCT01441102 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study
Interventions
- DRUG Dextromethorphan hydrobromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01441102 record still lists
NCT01441102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Dextromethorphan hydrobromide is the first listed.
NCT01441102 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01441102's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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