Diabetic Retinopathy
Conditions
Brief summary
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
Interventions
DRUGruboxistaurin
32 mg once daily (QD) oral for up to 36 months
DRUGplacebo
QD oral for up to 36 months
Sponsors
Chromaderm, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or Type 2 diabetes * 18 years or older * Non-clinically significant diabetic macular edema * Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye * Relatively good vision (20/30 or better)
Exclusion criteria
* Surgery or laser treatment in the study eye * Glaucoma in the study eye * Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg) * Liver disease, dialysis or renal transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change From Baseline at Endpoint in Albumin/Creatinine Ratio | 36 Months | — |
| 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. |
Countries
Australia, Brazil, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Poland, Portugal, Russia, Spain, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ruboxistaurin 32 mg once daily (QD) oral for up to 36 months | 371 |
| Placebo QD oral for up to 36 months | 360 |
| Total | 731 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 |
| Overall Study | Death | 9 | 9 |
| Overall Study | Lost to Follow-up | 26 | 29 |
| Overall Study | Physician Decision | 2 | 3 |
| Overall Study | Sponsor Decision | 3 | 1 |
| Overall Study | Withdrawal by Subject | 28 | 29 |
Baseline characteristics
| Characteristic | Total | Ruboxistaurin | Placebo |
|---|---|---|---|
| Age, Continuous | 55.17 years STANDARD_DEVIATION 11.01 | 55.20 years STANDARD_DEVIATION 10.85 | 55.15 years STANDARD_DEVIATION 11.18 |
| Blood Pressure Diastolic Blood Pressure | 77.73 millimeters of mercury (mmHg) STANDARD_DEVIATION 8.86 | 77.68 millimeters of mercury (mmHg) STANDARD_DEVIATION 8.68 | 77.77 millimeters of mercury (mmHg) STANDARD_DEVIATION 9.05 |
| Blood Pressure Systolic Blood Pressure | 133.20 millimeters of mercury (mmHg) STANDARD_DEVIATION 5.99 | 132.90 millimeters of mercury (mmHg) STANDARD_DEVIATION 15.25 | 133.50 millimeters of mercury (mmHg) STANDARD_DEVIATION 15.58 |
| Body Mass Index (BMI) | 29.86 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 5.99 | 29.90 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 6.09 | 29.82 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 5.89 |
| Diabetes Type Type 1 | 161 participants | 85 participants | 76 participants |
| Diabetes Type Type 2 | 570 participants | 286 participants | 284 participants |
| Diabetic Retinopathy (DR) Level 47 | 522 DR study eyes for each level | 250 DR study eyes for each level | 272 DR study eyes for each level |
| Diabetic Retinopathy (DR) Level <47 | 886 DR study eyes for each level | 465 DR study eyes for each level | 421 DR study eyes for each level |
| Diabetic Retinopathy (DR) Level 53 | 10 DR study eyes for each level | 7 DR study eyes for each level | 3 DR study eyes for each level |
| Duration of diabetes | 15.70 years STANDARD_DEVIATION 7.75 | 15.82 years STANDARD_DEVIATION 8 | 15.57 years STANDARD_DEVIATION 7.48 |
| Glycosylated hemoglobin (HbA1c) | 8.19 percent glycosylated hemoglobin STANDARD_DEVIATION 1.31 | 8.14 percent glycosylated hemoglobin STANDARD_DEVIATION 1.31 | 8.25 percent glycosylated hemoglobin STANDARD_DEVIATION 1.31 |
| Insulin use No | 262 participants | 130 participants | 132 participants |
| Insulin use Yes | 469 participants | 241 participants | 228 participants |
| Number of diabetic retinopathy (DR) study eyes per participant One | 44 participants | 20 participants | 24 participants |
| Number of diabetic retinopathy (DR) study eyes per participant Two | 687 participants | 351 participants | 336 participants |
| Region of Enrollment Australia | 37 participants | 20 participants | 17 participants |
| Region of Enrollment Brazil | 29 participants | 13 participants | 16 participants |
| Region of Enrollment Canada | 47 participants | 22 participants | 25 participants |
| Region of Enrollment Denmark | 54 participants | 26 participants | 28 participants |
| Region of Enrollment France | 21 participants | 11 participants | 10 participants |
| Region of Enrollment Germany | 41 participants | 22 participants | 19 participants |
| Region of Enrollment India | 51 participants | 25 participants | 26 participants |
| Region of Enrollment Italy | 14 participants | 8 participants | 6 participants |
| Region of Enrollment Mexico | 44 participants | 22 participants | 22 participants |
| Region of Enrollment Netherlands | 17 participants | 9 participants | 8 participants |
| Region of Enrollment Poland | 36 participants | 20 participants | 16 participants |
| Region of Enrollment Portugal | 31 participants | 15 participants | 16 participants |
| Region of Enrollment Russian Federation | 52 participants | 28 participants | 24 participants |
| Region of Enrollment Spain | 24 participants | 13 participants | 11 participants |
| Region of Enrollment Taiwan | 4 participants | 3 participants | 1 participants |
| Region of Enrollment United Kingdom | 39 participants | 21 participants | 18 participants |
| Region of Enrollment United States | 190 participants | 93 participants | 97 participants |
| Sex: Female, Male Female | 275 Participants | 138 Participants | 137 Participants |
| Sex: Female, Male Male | 456 Participants | 233 Participants | 223 Participants |
| Visual Acuity Score (Letters Correct) | 84.19 Letters read correctly STANDARD_DEVIATION 7.81 | 84.12 Letters read correctly STANDARD_DEVIATION 7.93 | 84.27 Letters read correctly STANDARD_DEVIATION 7.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 298 / 371 | 299 / 360 |
| serious Total, serious adverse events | 93 / 371 | 82 / 360 |
Outcome results
Primary
Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
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.
Time frame: 6 Months through 36 Months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruboxistaurin | Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) | 1.72 months per participant | Standard Deviation 4.95 |
| Placebo | Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) | 1.69 months per participant | Standard Deviation 4.41 |
p-value: 0.96995% CI: [-0.714, 0.686]ANOVA
Primary
Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
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.
Time frame: Baseline, 36 Months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruboxistaurin | Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye | Yes | 8 participants |
| Ruboxistaurin | Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye | No | 334 participants |
| Placebo | Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye | Yes | 16 participants |
| Placebo | Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye | No | 315 participants |
p-value: 0.08195% CI: [0.2, 1.12]Chi-squared
Secondary
Change From Baseline at Endpoint in Albumin/Creatinine Ratio
Time frame: 36 Months
Population: The completer population includes participants who completed all 36 months of the treatment phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruboxistaurin | Change From Baseline at Endpoint in Albumin/Creatinine Ratio | Baseline (n=270,261) | 123.53 micrograms/millimole (ug/mmol) | Standard Deviation 507.93 |
| Ruboxistaurin | Change From Baseline at Endpoint in Albumin/Creatinine Ratio | Change from baseline (n=267,253) | 135.90 micrograms/millimole (ug/mmol) | Standard Deviation 865.34 |
| Placebo | Change From Baseline at Endpoint in Albumin/Creatinine Ratio | Baseline (n=270,261) | 152.61 micrograms/millimole (ug/mmol) | Standard Deviation 623.98 |
| Placebo | Change From Baseline at Endpoint in Albumin/Creatinine Ratio | Change from baseline (n=267,253) | 72.69 micrograms/millimole (ug/mmol) | Standard Deviation 720.35 |
p-value: 0.36595% CI: [-73.68, 200.12]t-test, 2 sided
Secondary
Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 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.
Time frame: 36 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruboxistaurin | Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months | Baseline (n=351,342) | 67.86 units on a scale | Standard Deviation 8.25 |
| Ruboxistaurin | Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months | Change from baseline (n=314,309) | 0.17 units on a scale | Standard Deviation 6.21 |
| Placebo | Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months | Baseline (n=351,342) | 67.56 units on a scale | Standard Deviation 7.85 |
| Placebo | Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months | Change from baseline (n=314,309) | -1.36 units on a scale | Standard Deviation 8.56 |
p-value: 0.00995% CI: [0.38, 2.66]ANCOVA
Secondary
Change From Baseline in Contrast Sensitivity by Pelli-Robson
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.
Time frame: Baseline, 36 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruboxistaurin | Change From Baseline in Contrast Sensitivity by Pelli-Robson | Baseline (letters correct) (n=718,689) | 33.54 Letters read correctly | Standard Deviation 3.33 |
| Ruboxistaurin | Change From Baseline in Contrast Sensitivity by Pelli-Robson | Change from baseline (n=685,664) | -0.54 Letters read correctly | Standard Deviation 3.84 |
| Placebo | Change From Baseline in Contrast Sensitivity by Pelli-Robson | Baseline (letters correct) (n=718,689) | 33.71 Letters read correctly | Standard Deviation 3.54 |
| Placebo | Change From Baseline in Contrast Sensitivity by Pelli-Robson | Change from baseline (n=685,664) | -1.06 Letters read correctly | Standard Deviation 4.68 |
p-value: 0.04195% CI: [0.02, 0.87]ANCOVA
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate
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.
Time frame: Baseline, 36 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruboxistaurin | Change From Baseline in Estimated Glomerular Filtration Rate | Baseline (n=368,358) | 85.35 milliliter/minute/1.73 square meter | Standard Deviation 22.24 |
| Ruboxistaurin | Change From Baseline in Estimated Glomerular Filtration Rate | Change from baseline (n=340,328) | -5.55 milliliter/minute/1.73 square meter | Standard Deviation 15.7 |
| Placebo | Change From Baseline in Estimated Glomerular Filtration Rate | Baseline (n=368,358) | 87.27 milliliter/minute/1.73 square meter | Standard Deviation 23.44 |
| Placebo | Change From Baseline in Estimated Glomerular Filtration Rate | Change from baseline (n=340,328) | -7.92 milliliter/minute/1.73 square meter | Standard Deviation 17.31 |
p-value: 0.21195% CI: [-0.87, 3.92]ANCOVA
Secondary
Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 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.
Time frame: Baseline, 36 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruboxistaurin | Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Baseline (letters correct) (n=722, 695) | 84.12 Letters read correctly | Standard Deviation 7.93 |
| Ruboxistaurin | Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Change from baseline (n=687,670) | -1.14 Letters read correctly | Standard Deviation 7.38 |
| Placebo | Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Baseline (letters correct) (n=722, 695) | 84.27 Letters read correctly | Standard Deviation 7.7 |
| Placebo | Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months | Change from baseline (n=687,670) | -2.30 Letters read correctly | Standard Deviation 9.21 |
p-value: 0.01595% CI: [0.21, 1.97]ANCOVA
Secondary
First Occurrence of Focal/Grid Photocoagulation
The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.
Time frame: Baseline through 36 Months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruboxistaurin | First Occurrence of Focal/Grid Photocoagulation | Yes | 32 participants |
| Ruboxistaurin | First Occurrence of Focal/Grid Photocoagulation | No | 339 participants |
| Placebo | First Occurrence of Focal/Grid Photocoagulation | Yes | 27 participants |
| Placebo | First Occurrence of Focal/Grid Photocoagulation | No | 333 participants |
p-value: 0.577Chi-squared
Secondary
Number of Participants With Adverse Events
Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Time frame: Baseline through 36 Months
Population: Safety population: all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruboxistaurin | Number of Participants With Adverse Events | Serious adverse events | 93 participants |
| Ruboxistaurin | Number of Participants With Adverse Events | Adverse events | 298 participants |
| Placebo | Number of Participants With Adverse Events | Serious adverse events | 82 participants |
| Placebo | Number of Participants With Adverse Events | Adverse events | 299 participants |
Secondary
Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography
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.
Time frame: Baseline through 36 Months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruboxistaurin | Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography | Progression | 43 participants |
| Ruboxistaurin | Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography | No progression | 328 participants |
| Placebo | Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography | No progression | 312 participants |
| Placebo | Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography | Progression | 48 participants |
p-value: 0.475Chi-squared