Trial · NCT00090519
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
NCT00090519, Phase 3, Completed, Chromaderm, Inc.; results first posted 2016-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Reduction in the Occurrence of Center-Involved Diabetic Macular Edema. Trials, record NCT00090519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00090519
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
- NCT number
- NCT00090519
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 731 participants, actual
- Lead sponsor
- Chromaderm, Inc.
- Conditions
- Diabetic Retinopathy
- Interventions
- ruboxistaurin, placebo
- First posted
- 2004-08-31
- Last updated
- 2016-10-06
- Results first posted
- 2016-05-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) | 6 Months through 36 Months | Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed. |
| Primary | Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye | Baseline, 36 Months | The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. |
| Secondary | Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Baseline, 36 Months | ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes. |
| Secondary | First Occurrence of Focal/Grid Photocoagulation | Baseline through 36 Months | The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula. |
| Secondary | Change From Baseline in Contrast Sensitivity by Pelli-Robson | Baseline, 36 Months | Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes. |
| Secondary | Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography | Baseline through 36 Months | Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate | Baseline, 36 Months | The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration \[mg/deciliter (dL)\])-0.999 X (Age \[years\]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration \[mg/dL\])-0.170 X (Serum albumin concentration \[grams (g)/dL\])+0.318. |
| Secondary | Change From Baseline at Endpoint in Albumin/Creatinine Ratio | 36 Months | |
| Secondary | Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months | 36 Months | 25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning. |
| Secondary | Number of Participants With Adverse Events | Baseline through 36 Months | Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) | 6 Months through 36 Months | Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. | months per participant | MEAN |
| SECONDARY | Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Baseline, 36 Months | Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. | Letters read correctly | MEAN |
| SECONDARY | First Occurrence of Focal/Grid Photocoagulation | Baseline through 36 Months | Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. | participants | NUMBER |
| SECONDARY | Change From Baseline in Contrast Sensitivity by Pelli-Robson | Baseline, 36 Months | Intent-to-treat (ITT) population: all randomized participants analyzed according to treatment group to which they were originally assigned by random allocation even if they did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. | Letters read correctly | MEAN |
| SECONDARY | Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography | Baseline through 36 Months | Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. | participants | NUMBER |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate | Baseline, 36 Months | Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. | milliliter/minute/1.73 square meter | MEAN |
| SECONDARY | Change From Baseline at Endpoint in Albumin/Creatinine Ratio | 36 Months | The completer population includes participants who completed all 36 months of the treatment phase. | micrograms/millimole (ug/mmol) | MEAN |
| SECONDARY | Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months | 36 Months | Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events | Baseline through 36 Months | Safety population: all randomized participants who received at least one dose of study drug. | participants | NUMBER |
| PRIMARY | Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye | Baseline, 36 Months | Intent-to-treat (ITT) population: all randomized participants with at least 1 eligible study eye analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) | Ruboxistaurin | 1.72 | Standard Deviation 4.95 | months per participant | |
| Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) | Placebo | 1.69 | Standard Deviation 4.41 | months per participant | |
| Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Ruboxistaurin | Baseline (letters correct) (n=722, 695) | 84.12 | Standard Deviation 7.93 | Letters read correctly |
| Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Placebo | Baseline (letters correct) (n=722, 695) | 84.27 | Standard Deviation 7.70 | Letters read correctly |
| Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Ruboxistaurin | Change from baseline (n=687,670) | -1.14 | Standard Deviation 7.38 | Letters read correctly |
| Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Placebo | Change from baseline (n=687,670) | -2.30 | Standard Deviation 9.21 | Letters read correctly |
| First Occurrence of Focal/Grid Photocoagulation | Ruboxistaurin | Yes | 32 | participants | |
| First Occurrence of Focal/Grid Photocoagulation | Placebo | Yes | 27 | participants | |
| First Occurrence of Focal/Grid Photocoagulation | Ruboxistaurin | No | 339 | participants | |
| First Occurrence of Focal/Grid Photocoagulation | Placebo | No | 333 | participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ruboxistaurin | 371 | |
| Overall Study | STARTED | Placebo | 360 | |
| Overall Study | COMPLETED | Ruboxistaurin | 298 | |
| Overall Study | COMPLETED | Placebo | 285 | |
| Overall Study | NOT COMPLETED | Ruboxistaurin | 73 | |
| Overall Study | NOT COMPLETED | Placebo | 75 |
Source ClinicalTrials.gov
Adverse events432
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 | Diarrhoea | Gastrointestinal disorders | Ruboxistaurin | 38 | 371 | 90 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 32 | 360 | 108 |
| other | Nausea | Gastrointestinal disorders | Ruboxistaurin | 17 | 371 | 23 |
| other | Nausea | Gastrointestinal disorders | Placebo | 21 | 360 | 60 |
| other | Vomiting | Gastrointestinal disorders | Ruboxistaurin | 19 | 371 | 22 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 17 | 360 | 25 |
| other | Oedema peripheral | General disorders | Ruboxistaurin | 16 | 371 | 60 |
| other | Oedema peripheral | General disorders | Placebo | 24 | 360 | 86 |
| other | Pyrexia | General disorders | Ruboxistaurin | 15 | 371 | 18 |
| other | Pyrexia | General disorders | Placebo | 19 | 360 | 19 |
1 to 10 of 432Source ClinicalTrials.gov
See all 432 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 | 298 | 371 |
| Total, other adverse events | Placebo | 299 | 360 |
| Total, serious adverse events | Ruboxistaurin | 93 | 371 |
| Total, serious adverse events | Placebo | 82 | 360 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23404115 | 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/NCT00090519
GET https://conductscience.org/api/trials/v1/NCT00090519/results?page=2