Trial · NCT02140164
Study of Oral Minocycline in Treating Bilateral Cystoid Macular Edema Associated With Retinitis Pigmentosa
NCT02140164, Phase 1, Phase 2, Completed, National Eye Institute (NEI); results first posted 2017-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Oral Minocycline in Treating Bilateral Cystoid Macular Edema Associated With Retinitis Pigmentosa. Trials, record NCT02140164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02140164
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Oral Minocycline in Treating Bilateral Cystoid Macular Edema Associated With Retinitis Pigmentosa
- NCT number
- NCT02140164
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Retinitis Pigmentosa
- Interventions
- Minocycline
- First posted
- 2014-05-16
- Last updated
- 2024-04-17
- Results first posted
- 2017-01-16
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 6 Months Compared to the Average of the Pre-treatment Values. | Pre-treatment and 6 Months | Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value. |
| Secondary | Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 12 Months Compared to the Average of the Pre-treatment Values | Pre-treatment and 12 Months | Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value. |
| Secondary | Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 6 Months as Compared to the Average of Pre-treatment Values | Pre-Treatment and 6 Months | This outcome measure will not be reported. |
| Secondary | Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 12 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 12 Months | This outcome measure will not be reported. |
| Secondary | Change in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 6 Months | Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the microperimetry measurements at these three visits was used as the pre-treatment value. |
| Secondary | Change in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 12 Months | Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the microperimetry measurements at these three visits was used as the pre-treatment value. |
| Secondary | Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 6 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 6 Months | Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the HVF 30-2 measurements at these three visits was used as the pre-treatment value. |
| Secondary | Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 12 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 12 Months | Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the HVF 30-2 measurements at these three visits was used as the pre-treatment value. |
| Secondary | Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline | Baseline and 12 Months | Visual Acuity was measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. |
| Secondary | Number of Ocular Adverse Events | Study Duration, up to 16 Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 6 Months Compared to the Average of the Pre-treatment Values. | Pre-treatment and 6 Months | Participants receiving investigational product (IP) at the Month 6 visit were included in the primary efficacy analysis. | microns | MEAN |
| SECONDARY | Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 12 Months Compared to the Average of the Pre-treatment Values | Pre-treatment and 12 Months | microns | MEAN | |
| SECONDARY | Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 6 Months as Compared to the Average of Pre-treatment Values | Pre-Treatment and 6 Months | Participants had non-recordable ERGs; therefore, changes could not be measured. | ||
| SECONDARY | Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 12 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 12 Months | Participants had non-recordable ERGs; therefore, changes could not be measured. | ||
| SECONDARY | Change in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 6 Months | decibels (dB) | MEAN | |
| SECONDARY | Change in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 12 Months | dB | MEAN | |
| SECONDARY | Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 6 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 6 Months | Two participants had to switch to HVF 10-2; therefore they were not included in the analysis. | dB | MEAN |
| SECONDARY | Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 12 Months as Compared to the Average of Pre-treatment Values | Pre-treatment and 12 Months | dB | MEAN | |
| SECONDARY | Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline | Baseline and 12 Months | eyes | NUMBER | |
| SECONDARY | Number of Ocular Adverse Events | Study Duration, up to 16 Months | All participants were included in the safety analysis. | adverse events | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 6 Months Compared to the Average of the Pre-treatment Values. | Minocycline | -16.7 | Standard Deviation 42.16 | microns | |
| Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 12 Months Compared to the Average of the Pre-treatment Values | Minocycline | -37.3 | Standard Deviation 52.90 | microns | |
| Change in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values | Minocycline | -1.01 | Standard Deviation 0.36 | decibels (dB) | |
| Change in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values | Minocycline | -1.02 | Standard Deviation 0.45 | dB | |
| Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 6 Months as Compared to the Average of Pre-treatment Values | Minocycline | -3.62 | Standard Deviation 5.80 | dB | |
| Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 12 Months as Compared to the Average of Pre-treatment Values | Minocycline | 1.69 | Standard Deviation 5.52 | dB | |
| Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline | Minocycline | 0 | eyes | ||
| Number of Ocular Adverse Events | Minocycline | 3 | adverse events | ||
| Number of Non-ocular Adverse Events | Minocycline | 12 | adverse events | ||
| Number of Severe Adverse Events | Minocycline | 0 | adverse events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Minocycline | 7 | |
| Overall Study | COMPLETED | Minocycline | 5 | |
| Overall Study | NOT COMPLETED | Minocycline | 2 |
Source ClinicalTrials.gov
Adverse events14
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 | Nasopharyngitis | Infections and infestations | Minocycline | 1 | 7 | 1 |
| other | Headache | Nervous system disorders | Minocycline | 1 | 7 | 1 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Minocycline | 1 | 7 | 1 |
| other | Influenza | Infections and infestations | Minocycline | 1 | 7 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | Minocycline | 1 | 7 | 1 |
| other | Depression | Psychiatric disorders | Minocycline | 1 | 7 | 1 |
| other | Attention deficit/hyperactivity disorder | Psychiatric disorders | Minocycline | 1 | 7 | 1 |
| other | Conjunctivitis | Infections and infestations | Minocycline | 1 | 7 | 1 |
| other | Vomiting | Gastrointestinal disorders | Minocycline | 1 | 7 | 1 |
| other | Vulvovaginal mycotic infection | Infections and infestations | Minocycline | 1 | 7 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Minocycline | ||
| Total, other adverse events | Minocycline | 6 | 7 |
| Total, serious adverse events | Minocycline | 0 | 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/NCT02140164
GET https://conductscience.org/api/trials/v1/NCT02140164/registered