Trial · NCT00266695
Treatment for Completers of the Study B7A-MC-MBCM
NCT00266695, Phase 3, Completed, Chromaderm, Inc.; results first posted 2016-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment for Completers of the Study B7A-MC-MBCM. Trials, record NCT00266695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00266695
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment for Completers of the Study B7A-MC-MBCM
- NCT number
- NCT00266695
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 203 participants, actual
- Lead sponsor
- Chromaderm, Inc.
- Conditions
- Diabetic Retinopathy
- Interventions
- Ruboxistaurin
- First posted
- 2005-12-19
- Last updated
- 2016-10-06
- Results first posted
- 2016-01-28
- Limitations and caveats
- A participant could have one or both eyes meet the criteria for a diabetic retinopathy (DR) study eye as defined in study B7A-MC-MBCM.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained Moderate Visual Loss (SMVL) | Baseline, 18 months up to 24 months | The number of participants who experienced SMVL in at least 1 diabetic retinopathy (DR) study eye. SMVL was a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of the study. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If \<20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). |
| Secondary | Vision Loss | End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months | The number of participants whose best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in at least 1 diabetic retinopathy (DR) study eye decreased by 15-letters or less from the conclusion of Study MBCM to the start of Study MBDV, 6 to 18 months later. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If \<20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). |
| Secondary | Sustained Moderate Vision Loss (SMVL), Long Term | Baseline in Study MBCM, 18 months up to 24 months in Study MBDV (for a total of 75 up to 87 months of SMVL, long term) | The number of participants who experienced SMVL, long term, in at least 1 diabetic retinopathy (DR) study eye. Long term SMVL was a ≥15-letter decrease from Study MBCM baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of Study MBDV. VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If \<20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). |
| Secondary | Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval | Baseline up to 6 months, 6 months up to 12 months, 12 months up to 18 months, 18 months up to 24 months, and 24 months up to 30 months | An mSMVL event was defined as a ≥15-letter decrease from Study MBDV baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) during any 6-month period, not just the last 6 months of the study. An mSMVL event was the first occurrence of an mSMVL in a participant, and the time at which the mSMVL began was used as the time of the event for the analysis. VA was measured at 4 meters (m) using an eye chart with 5 letters per row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If \<20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. |
| Secondary | Visual Acuity | Month 24 | Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If \<20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). A higher score represented better VA. |
| Secondary | Number of Participants Receiving Treatment With Focal/Grid Photocoagulation | Baseline up to Month 24 | |
| Secondary | Number of Participants Receiving Treatment With Panretinal Photocoagulation | Baseline up to Month 24 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sustained Moderate Visual Loss (SMVL) | Baseline, 18 months up to 24 months | All enrolled participants. | participants | NUMBER |
| SECONDARY | Vision Loss | End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months | All enrolled participants. | participants | NUMBER |
| SECONDARY | Sustained Moderate Vision Loss (SMVL), Long Term | Baseline in Study MBCM, 18 months up to 24 months in Study MBDV (for a total of 75 up to 87 months of SMVL, long term) | Participants who were treated with 32 milligram (mg) ruboxistaurin once daily in Study MBCM and had at least 1 DR study eye, who were also enrolled in Study MBDV. | participants | NUMBER |
| SECONDARY | Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval | Baseline up to 6 months, 6 months up to 12 months, 12 months up to 18 months, 18 months up to 24 months, and 24 months up to 30 months | All enrolled participants (pts) at risk during the specified intervals. Pts who did not experience an event during the interval were censored to the last time point in the interval. Number of pts censored: 0 to 6 months = 2 pts, 6 to 12 months = 4 pts, 12 to 18 months = 9 pts, 18 to 24 months = 82 pts, and 24 to 30 months = 90 pts. | participants | NUMBER |
| SECONDARY | Visual Acuity | Month 24 | All enrolled participants. Last observation carried forward (LOCF). | letters read correctly | MEAN |
| SECONDARY | Number of Participants Receiving Treatment With Focal/Grid Photocoagulation | Baseline up to Month 24 | All enrolled participants. | participants | NUMBER |
| SECONDARY | Number of Participants Receiving Treatment With Panretinal Photocoagulation | Baseline up to Month 24 | All enrolled participants. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sustained Moderate Visual Loss (SMVL) | Ruboxistaurin | 10 | 2 to 9 | participants | |
| Vision Loss | Ruboxistaurin | 22 | 7 to 16 | participants | |
| Sustained Moderate Vision Loss (SMVL), Long Term | Ruboxistaurin | 8 | 3 to 15 | participants | |
| Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval | Ruboxistaurin | 0 up to 6 months, n=198 | 0 | participants | |
| Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval | Ruboxistaurin | 6 up to 12 months, n=196 | 4 | participants | |
| Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval | Ruboxistaurin | 12 up to 18 months, n=188 | 5 | participants | |
| Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval | Ruboxistaurin | 18 up to 24 months, n=174 | 2 | participants | |
| Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval | Ruboxistaurin | 24 up to 30 months, n=90 | 0 | participants | |
| Visual Acuity | Ruboxistaurin | 75.14 | Standard Deviation 14.92 | letters read correctly | |
| Number of Participants Receiving Treatment With Focal/Grid Photocoagulation | Ruboxistaurin | 19 | 6 to 14 | participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ruboxistaurin | 203 | |
| Overall Study | COMPLETED | Ruboxistaurin | 174 | |
| Overall Study | NOT COMPLETED | Ruboxistaurin | 29 |
Source ClinicalTrials.gov
Adverse events108
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 | Ruboxistaurin | 20 | 203 | 25 |
| other | Diarrhoea | Gastrointestinal disorders | Ruboxistaurin | 16 | 203 | 19 |
| other | Bronchitis | Infections and infestations | Ruboxistaurin | 12 | 203 | 14 |
| other | Nasopharyngitis | Infections and infestations | Ruboxistaurin | 22 | 203 | 32 |
| other | Upper respiratory tract infection | Infections and infestations | Ruboxistaurin | 11 | 203 | 11 |
| other | Urinary tract infection | Infections and infestations | Ruboxistaurin | 13 | 203 | 21 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ruboxistaurin | 18 | 203 | 20 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ruboxistaurin | 15 | 203 | 19 |
| other | Cataract operation | Surgical and medical procedures | Ruboxistaurin | 15 | 203 | 20 |
| other | Retinal laser coagulation | Surgical and medical procedures | Ruboxistaurin | 49 | 203 | 111 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruboxistaurin | ||
| Total, other adverse events | Ruboxistaurin | 166 | 203 |
| Total, serious adverse events | Ruboxistaurin | 57 | 203 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00266695
GET https://conductscience.org/api/trials/v1/NCT00266695/events?page=2