Trial · NCT01441102
Dextromethorphan for Diabetic Macular Edema
NCT01441102, Phase 1, Phase 2, Completed, National Eye Institute (NEI); results first posted 2015-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dextromethorphan for Diabetic Macular Edema. Trials, record NCT01441102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01441102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dextromethorphan for Diabetic Macular Edema
- NCT number
- NCT01441102
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Diabetic Macular Edema
- Interventions
- Dextromethorphan hydrobromide
- First posted
- 2011-09-27
- Last updated
- 2020-07-28
- Results first posted
- 2015-06-08
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline | Baseline and 6 months | 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 eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye." |
| Secondary | Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline | Baseline and 12 Months | 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. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid. |
| Secondary | Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline | Baseline and 18 Months | 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. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid. |
| Secondary | Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline | Baseline and 24 Months | 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. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid. |
| Secondary | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline | Baseline and 6 Months | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline | Baseline and 12 Months | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline | Baseline and 18 Months | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline | Baseline and 24 Months | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline | Baseline and 6 Months | Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD). |
| Secondary | Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline | Baseline and 12 Months | Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline | Baseline and 6 months | Two participants withdrew from the study prior to the 6-month visit. | percentage change in retinal thickness | MEAN |
| SECONDARY | Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline | Baseline and 12 Months | percentage change in retinal thickness | MEAN | |
| SECONDARY | Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline | Baseline and 18 Months | percentage change in retinal thickness | MEAN | |
| SECONDARY | Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline | Baseline and 24 Months | percentage change in retinal thickness | MEAN | |
| SECONDARY | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline | Baseline and 6 Months | Two participants withdrew from the study prior to the 6-month visit. | ETDRS letters | MEAN |
| SECONDARY | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline | Baseline and 12 Months | ETDRS letters | MEAN | |
| SECONDARY | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline | Baseline and 18 Months | ETDRS letters | MEAN | |
| SECONDARY | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline | Baseline and 24 Months | ETDRS letters | MEAN | |
| SECONDARY | Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline | Baseline and 6 Months | eyes | NUMBER | |
| SECONDARY | Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline | Baseline and 12 Months | eyes | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline | Dextromethorphan Hydrobromide | -7.89 | Standard Deviation 15.18 | percentage change in retinal thickness | |
| Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline | Dextromethorphan Hydrobromide | 6.54 | Standard Deviation 26.96 | percentage change in retinal thickness | |
| Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline | Dextromethorphan Hydrobromide | -0.99 | Standard Deviation 19.11 | percentage change in retinal thickness | |
| Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline | Dextromethorphan Hydrobromide | -7.44 | Standard Deviation 18.33 | percentage change in retinal thickness | |
| Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline | Dextromethorphan Hydrobromide | 0.60 | Standard Deviation 11.44 | ETDRS letters | |
| Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline | Dextromethorphan Hydrobromide | 1.50 | Standard Deviation 15.02 | ETDRS letters | |
| Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline | Dextromethorphan Hydrobromide | 4.00 | Standard Deviation 10.74 | ETDRS letters | |
| Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline | Dextromethorphan Hydrobromide | 5.50 | Standard Deviation 12.58 | ETDRS letters | |
| Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline | Dextromethorphan Hydrobromide | 4 | eyes | ||
| Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline | Dextromethorphan Hydrobromide | 3 | eyes |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dextromethorphan Hydrobromide | 7 | |
| Overall Study | COMPLETED | Dextromethorphan Hydrobromide | 4 | |
| Overall Study | NOT COMPLETED | Dextromethorphan Hydrobromide | 3 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vitreous haemorrhage | Eye disorders | Dextromethorphan Hydrobromide | 2 | 7 | 2 |
| other | Malaise | General disorders | Dextromethorphan Hydrobromide | 1 | 7 | 1 |
| other | Fatigue | General disorders | Dextromethorphan Hydrobromide | 3 | 7 | 3 |
| other | Nephrolithiasis | Renal and urinary disorders | Dextromethorphan Hydrobromide | 1 | 7 | 1 |
| other | Photophobia | Eye disorders | Dextromethorphan Hydrobromide | 1 | 7 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Dextromethorphan Hydrobromide | 1 | 7 | 2 |
| other | Blister | Skin and subcutaneous tissue disorders | Dextromethorphan Hydrobromide | 1 | 7 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Dextromethorphan Hydrobromide | 1 | 7 | 1 |
| other | Laceration | Injury, poisoning and procedural complications | Dextromethorphan Hydrobromide | 1 | 7 | 1 |
| other | Tooth infection | Infections and infestations | Dextromethorphan Hydrobromide | 1 | 7 | 1 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dextromethorphan Hydrobromide | ||
| Total, other adverse events | Dextromethorphan Hydrobromide | 6 | 7 |
| Total, serious adverse events | Dextromethorphan Hydrobromide | 1 | 7 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01441102
GET https://conductscience.org/api/trials/v1/NCT01441102/events?page=2