A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RIDE) (RIDE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00473382 |
Recruitment Status
:
Completed
First Posted
: May 15, 2007
Results First Posted
: January 17, 2013
Last Update Posted
: April 17, 2017
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions: |
Diabetes Mellitus Macular Edema |
Interventions: |
Drug: Ranibizumab Drug: Sham injection |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Patients were recruited from study sites in the United States, Argentina, Peru, Columbia, Chile, and Peru. There were 47 patients from the Latin American countries. |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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No text entered. |
Reporting Groups
Description | |
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Sham Injection/Ranibizumab 0.5 mg | Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. |
Ranibizumab 0.3 mg | Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. |
Ranibizumab 0.5 mg | Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. |
Participant Flow for 3 periods
Period 1: Core Study
Sham Injection/Ranibizumab 0.5 mg | Ranibizumab 0.3 mg | Ranibizumab 0.5 mg | |
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STARTED | 130 | 125 | 127 |
COMPLETED | 102 | 98 | 98 |
NOT COMPLETED | 28 | 27 | 29 |
Adverse Event | 3 | 1 | 1 |
Death | 3 | 5 | 10 |
Lost to Follow-up | 3 | 3 | 3 |
Physician Decision | 1 | 2 | 2 |
Subject non-compliance | 5 | 2 | 1 |
Subject needed other treatment | 1 | 3 | 2 |
Subject's decision | 12 | 11 | 10 |
Period 2: Open-label Extension Through Month 48
Sham Injection/Ranibizumab 0.5 mg | Ranibizumab 0.3 mg | Ranibizumab 0.5 mg | |
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STARTED | 88 [1] | 83 [1] | 84 [1] |
COMPLETED | 38 | 42 | 37 |
NOT COMPLETED | 50 | 41 | 47 |
Adverse Event | 0 | 0 | 1 |
Death | 1 | 3 | 3 |
Lost to Follow-up | 1 | 2 | 1 |
Subject's Decision | 5 | 1 | 6 |
Sponsor’s Decision to Terminate Study | 41 | 34 | 36 |
Subject Required Other Intervention | 2 | 1 | 0 |
[1] | Not all participants who completed the core study entered the optional open-label extension. |
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Period 3: Open-label Extension Through Month 60
Sham Injection/Ranibizumab 0.5 mg | Ranibizumab 0.3 mg | Ranibizumab 0.5 mg | |
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STARTED | 88 [1] | 83 [1] | 84 [1] |
COMPLETED | 2 | 1 | 2 |
NOT COMPLETED | 86 | 82 | 82 |
Adverse Event | 0 | 0 | 2 |
Death | 1 | 7 | 4 |
Lost to Follow-up | 1 | 3 | 1 |
Subject's Decision | 7 | 1 | 6 |
Sponsor’s Decision to Terminate Study | 75 | 70 | 69 |
Subject Required Other Intervention | 2 | 1 | 0 |
[1] | Not all participants who completed the core study entered the optional open-label extension. |
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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The Baseline Characteristics of the patients enrolled in the open-label extension phase (N=88, 83, 84 patients originally randomized to the ranibizumab 0.3 mg, ranibizumab 0.5 mg, and sham injection groups, respectively) were similar to the Baseline Characteristics of the patients enrolled in the core study. |
Reporting Groups
Description | |
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Ranibizumab 0.3 mg | Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. |
Ranibizumab 0.5 mg | Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. |
Sham Injection | Patients randomized to this group received a sham intravitreal injection monthly for 24 months. |
Total | Total of all reporting groups |
Baseline Measures
Ranibizumab 0.3 mg | Ranibizumab 0.5 mg | Sham Injection | Total | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [Units: Participants] |
125 | 127 | 130 | 382 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Age [Units: Years] Mean (Standard Deviation) |
62.7 (11.1) | 61.8 (10.1) | 63.5 (10.8) | 62.7 (10.7) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sex: Female, Male [Units: Participants] Count of Participants |
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Female | 52 41.6% | 47 37.0% | 64 49.2% | 163 42.7% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Male | 73 58.4% | 80 63.0% | 66 50.8% | 219 57.3% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

1. Primary: | Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 [ Time Frame: Baseline to Month 24 ] |
2. Secondary: | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48 [ Time Frame: Baseline to Month 48 ] |
3. Secondary: | Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48 [ Time Frame: Months 24, 36, and 48 ] |
4. Secondary: | Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48 [ Time Frame: Baseline to Month 48 ] |
5. Secondary: | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline [ Time Frame: Baseline to Month 36 ] |
6. Secondary: | Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48 [ Time Frame: Baseline to Month 48 ] |
7. Secondary: | Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36 [ Time Frame: Baseline to Month 36 ] |
8. Secondary: | Percentage of Patients With Resolution of Leakage at Month 24 [ Time Frame: Baseline to Month 24 ] |
9. Secondary: | Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36 [ Time Frame: Baseline to Month 36 ] |

Measure Type | Secondary |
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Measure Title | Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36 |
Measure Description | The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3. |
Time Frame | Baseline to Month 36 |
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method. |
Reporting Groups
Description | |
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Ranibizumab 0.3 mg | Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. |
Ranibizumab 0.5 mg | Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. |
Sham Injection | Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. |
Sham Injection/Ranibizumab 0.5 mg | Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. |
Measured Values
Ranibizumab 0.3 mg | Ranibizumab 0.5 mg | Sham Injection | Sham Injection/Ranibizumab 0.5 mg | |
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Participants Analyzed [Units: Participants] |
125 | 127 | 130 | 130 |
Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36 [Units: Treatments] Mean (Standard Deviation) |
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Month 24 | 0.7 (1.4) | 0.3 (0.7) | 1.6 (1.6) | NA [1] |
Month 36 | 0.9 (1.8) | 0.4 (0.9) | NA [1] | 1.7 (1.6) |
[1] | NA = not applicable, see reporting groups. |
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Statistical Analysis 1 for Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36
Groups [1] | Ranibizumab 0.3 mg vs. Sham Injection |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | ANOVA |
P Value [4] | <0.0001 |
Mean Difference (Final Values) [5] | -0.9 |
95% Confidence Interval | -1.3 to -0.5 |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. | |
[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |
No text entered. | |
[3] | Other relevant method information, such as adjustments or degrees of freedom: |
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no). | |
[4] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure. | |
[5] | Other relevant estimation information: |
No text entered. |
Statistical Analysis 2 for Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36
Groups [1] | Ranibizumab 0.5 mg vs. Sham Injection |
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Statistical Test Type [2] | Superiority or Other |
Statistical Method [3] | ANOVA |
P Value [4] | <0.0001 |
Mean Difference (Final Values) [5] | -1.3 |
95% Confidence Interval | -1.6 to -1.0 |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. | |
[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |
No text entered. | |
[3] | Other relevant method information, such as adjustments or degrees of freedom: |
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no). | |
[4] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure. | |
[5] | Other relevant estimation information: |
No text entered. |
10. Secondary: | Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48 [ Time Frame: Baseline to Month 48 ] |
11. Secondary: | Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48 [ Time Frame: Month 36 to Month 48 ] |
12. Secondary: | Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48 [ Time Frame: Month 36 to Month 48 ] |
13. Secondary: | Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48 [ Time Frame: Month 36 to Month 48 ] |

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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No text entered. |

Certain Agreements:
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Results Point of Contact:
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800 821-8590
e-mail: genentech@druginfo.com
Organization: Genentech, Inc.
phone: 800 821-8590
e-mail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT00473382 History of Changes |
Other Study ID Numbers: |
FVF4168g |
First Submitted: | May 13, 2007 |
First Posted: | May 15, 2007 |
Results First Submitted: | November 30, 2012 |
Results First Posted: | January 17, 2013 |
Last Update Posted: | April 17, 2017 |