Trial · NCT00604383
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
NCT00604383, 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. Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study. Trials, record NCT00604383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00604383
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
- NCT number
- NCT00604383
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 685 participants, actual
- Lead sponsor
- Chromaderm, Inc.
- Conditions
- Diabetic Retinopathy
- Interventions
- ruboxistaurin, placebo
- First posted
- 2008-01-30
- Last updated
- 2016-10-06
- Results first posted
- 2016-01-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period | Baseline through 36 months | SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) \* 100. |
| Secondary | Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME) | Baseline through 36 months | DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) \* 100. |
| Secondary | Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR) | Baseline through 36 months | Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) \* 100. |
| Secondary | Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) | Baseline, up to 36 months | NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome). |
| Secondary | Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire | Baseline, up to 36 months | SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period | Baseline through 36 months | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME) | Baseline through 36 months | All randomized participants who had no center involved or imminently threatened DME at baseline. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR) | Baseline through 36 months | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) | Baseline, up to 36 months | All randomized participants with evaluable NEI-VFQ-25 total score. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. | units on a scale | MEAN |
| SECONDARY | Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire | Baseline, up to 36 months | All randomized participants with evaluable SF-36 MCS and PCS. LOCF was used to impute missing post-baseline values | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period | Ruboxistaurin | 5.5 | percentage of participants | ||
| Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period | Placebo | 9.1 | percentage of participants | ||
| Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME) | Ruboxistaurin | 44.4 | percentage of participants | ||
| Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME) | Placebo | 49.0 | percentage of participants | ||
| Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR) | Ruboxistaurin | 35.9 | percentage of participants | ||
| Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR) | Placebo | 36.5 | percentage of participants | ||
| Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) | Ruboxistaurin | -3.82 | Standard Deviation 14.75 | units on a scale | |
| Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) | Placebo | -4.10 | Standard Deviation 13.45 | units on a scale | |
| Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire | Ruboxistaurin | MCS | -12.21 | Standard Deviation 70.91 | units on a scale |
| Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire | Placebo | MCS | -19.85 | Standard Deviation 70.05 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ruboxistaurin | 345 | |
| Overall Study | STARTED | Placebo | 340 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Ruboxistaurin | 345 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 340 | |
| Overall Study | Received Extended Treatment | Ruboxistaurin | 136 | |
| Overall Study | Received Extended Treatment | Placebo | 141 | |
| Overall Study | COMPLETED | Ruboxistaurin | 258 | |
| Overall Study | COMPLETED | Placebo | 256 | |
| Overall Study | NOT COMPLETED | Ruboxistaurin | 87 | |
| Overall Study | NOT COMPLETED | Placebo | 84 |
Source ClinicalTrials.gov
Adverse events798
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 | Anaemia | Blood and lymphatic system disorders | Ruboxistaurin | 30 | 345 | 33 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 36 | 340 | 37 |
| other | Dry eye | Eye disorders | Ruboxistaurin | 17 | 345 | 19 |
| other | Dry eye | Eye disorders | Placebo | 19 | 340 | 21 |
| other | Eye pain | Eye disorders | Ruboxistaurin | 22 | 345 | 30 |
| other | Eye pain | Eye disorders | Placebo | 18 | 340 | 28 |
| other | Maculopathy | Eye disorders | Ruboxistaurin | 14 | 345 | 19 |
| other | Maculopathy | Eye disorders | Placebo | 17 | 340 | 17 |
| other | Vision blurred | Eye disorders | Ruboxistaurin | 18 | 345 | 22 |
| other | Vision blurred | Eye disorders | Placebo | 19 | 340 | 26 |
1 to 10 of 798Source ClinicalTrials.gov
See all 798 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruboxistaurin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ruboxistaurin | 314 | 345 |
| Total, other adverse events | Placebo | 322 | 340 |
| Total, serious adverse events | Ruboxistaurin | 145 | 345 |
| Total, serious adverse events | Placebo | 157 | 340 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18708615 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ruboxistaurin vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00604383
GET https://conductscience.org/api/trials/v1/NCT00604383/events?page=2