Trial · NCT01442064
An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)
NCT01442064, Not applicable, Completed, Genentech, Inc.; results first posted 2012-01-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2). Trials, record NCT01442064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01442064
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)
- NCT number
- NCT01442064
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 608 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Interventions
- Ranibizumab 0.5 mg
- First posted
- 2011-09-28
- Last updated
- 2012-01-10
- Results first posted
- 2012-01-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Ocular Adverse Events in the Study Eye | Up to 24 months | Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. |
| Primary | Number of Participants With Non-ocular Adverse Events | Up to 24 months | Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section. |
| Secondary | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Baseline (Day 0 of extension study), Months 6, 12, 18, and 24 | Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity. |
| Secondary | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Baseline (Day 0 of extension study), Months 6 and 12 | Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center. |
| Secondary | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Baseline (Day 0 of extension study), Months 12 and 24 | NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24. Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836). |
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 | Number of Participants With Ocular Adverse Events in the Study Eye | Up to 24 months | Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study. | participants | NUMBER |
| PRIMARY | Number of Participants With Non-ocular Adverse Events | Up to 24 months | Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study. | participants | NUMBER |
| SECONDARY | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Baseline (Day 0 of extension study), Months 6, 12, 18, and 24 | Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n. | letters | MEAN |
| SECONDARY | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Baseline (Day 0 of extension study), Months 6 and 12 | Enrolled participants for whom data was available for analyses at the given time-point as indicated by n in the categories. Observed data were used with no imputation. | µm | MEAN |
| SECONDARY | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | Baseline (Day 0 of extension study), Months 12 and 24 | Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (Sham BRAVO) | Any ocular adverse event (AE) | 51 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (0.3 mg BRAVO) | Any ocular adverse event (AE) | 64 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (0.5 mg BRAVO) | Any ocular adverse event (AE) | 63 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (Sham CRUISE) | Any ocular adverse event (AE) | 60 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (0.3 mg CRUISE) | Any ocular adverse event (AE) | 67 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (0.5 mg CRUISE) | Any ocular adverse event (AE) | 66 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (Sham BRAVO) | Ocular AE leading to treatment discontinuation | 1 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (0.3 mg BRAVO) | Ocular AE leading to treatment discontinuation | 2 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (0.5 mg BRAVO) | Ocular AE leading to treatment discontinuation | 2 | participants | |
| Number of Participants With Ocular Adverse Events in the Study Eye | Ranibizumab (Sham CRUISE) | Ocular AE leading to treatment discontinuation | 0 | participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab (Sham BRAVO) | 97 | |
| Overall Study | STARTED | Ranibizumab (0.3 mg BRAVO) | 103 | |
| Overall Study | STARTED | Ranibizumab (0.5 mg BRAVO) | 104 | |
| Overall Study | STARTED | Ranibizumab (Sham CRUISE) | 98 | |
| Overall Study | STARTED | Ranibizumab (0.3 mg CRUISE) | 107 | |
| Overall Study | STARTED | Ranibizumab (0.5 mg CRUISE) | 99 | |
| Overall Study | Ranibizumab-Treated Subjects | Ranibizumab (Sham BRAVO) | 93 | |
| Overall Study | Ranibizumab-Treated Subjects | Ranibizumab (0.3 mg BRAVO) | 103 | |
| Overall Study | Ranibizumab-Treated Subjects | Ranibizumab (0.5 mg BRAVO) | 104 | |
| Overall Study | Ranibizumab-Treated Subjects | Ranibizumab (Sham CRUISE) | 96 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events381
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 | CATARACT | Eye disorders | Ranibizumab (Sham) | 4 | 189 | |
| other | CATARACT | Eye disorders | Ranibizumab (0.3 mg) | 11 | 210 | |
| other | CATARACT | Eye disorders | Ranibizumab (0.5 mg) | 11 | 203 | |
| other | CONJUNCTIVAL HAEMORRHAGE | Eye disorders | Ranibizumab (Sham) | 29 | 189 | |
| other | CONJUNCTIVAL HAEMORRHAGE | Eye disorders | Ranibizumab (0.3 mg) | 37 | 210 | |
| other | CONJUNCTIVAL HAEMORRHAGE | Eye disorders | Ranibizumab (0.5 mg) | 31 | 203 | |
| other | CYSTOID MACULAR OEDEMA | Eye disorders | Ranibizumab (Sham) | 8 | 189 | |
| other | CYSTOID MACULAR OEDEMA | Eye disorders | Ranibizumab (0.3 mg) | 10 | 210 | |
| other | CYSTOID MACULAR OEDEMA | Eye disorders | Ranibizumab (0.5 mg) | 12 | 203 | |
| other | EYE PAIN | Eye disorders | Ranibizumab (Sham) | 12 | 189 |
1 to 10 of 381Source ClinicalTrials.gov
See all 381 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab (Sham) | ||
| Total, all-cause mortality | Ranibizumab (0.3 mg) | ||
| Total, all-cause mortality | Ranibizumab (0.5 mg) | ||
| Total, other adverse events | Ranibizumab (Sham) | 146 | 189 |
| Total, other adverse events | Ranibizumab (0.3 mg) | 179 | 210 |
| Total, other adverse events | Ranibizumab (0.5 mg) | 172 | 203 |
| Total, serious adverse events | Ranibizumab (Sham) | 32 | 189 |
| Total, serious adverse events | Ranibizumab (0.3 mg) | 49 | 210 |
| Total, serious adverse events | Ranibizumab (0.5 mg) | 46 | 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/NCT01442064
GET https://conductscience.org/api/trials/v1/NCT01442064/results?page=2