Trial · NCT01225146
Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)
NCT01225146, Phase 1, Terminated, David M. Brown, M.D.; results first posted 2017-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2). Trials, record NCT01225146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01225146
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)
- NCT number
- NCT01225146
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- David M. Brown, M.D.
- Conditions
- Ischemia, Retinal Vein Occlusion, Pathologic Processes, Retinal Diseases, Eye Diseases
- Interventions
- ranibizumab
- First posted
- 2010-10-20
- Last updated
- 2017-08-14
- Results first posted
- 2017-08-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in logMAR | 12 months. | Mean change from baseline in ETDRS NCVA. |
| Secondary | Incidence and Severity of Adverse Events (Ocular and Non-ocular). | 12 months | Incidence and severity of adverse events (ocular and non-ocular) from baseline through 12 months will be evaluated. |
| Secondary | Neovascularization Development | 12 months | Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere. |
| Secondary | Mean Change in Central Foveal Volume | 12 months | Mean change in Central Foveal Volume on High Resolution OCT |
| Secondary | Changes, by Disc Areas, of Capillary Non-perfusion in the Periphery | 12 months | Changes, by disc areas, of capillary non-perfusion in the periphery (evaluated by wide-field fluorescein angiography) at 3, 6, 9 and 12 months from baseline. |
| Secondary | Goldman Visual Field Changes | 12 months | Goldman Visual Field changes at 6 and 12 months from baseline |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in logMAR | 12 months. | Patients in cohort 2 did not complete the study. | logMAR | MEAN |
| SECONDARY | Incidence and Severity of Adverse Events (Ocular and Non-ocular). | 12 months | incidents | NUMBER | |
| SECONDARY | Neovascularization Development | 12 months | Patients in cohort 2 did not complete the study. | Percentage of patients | NUMBER |
| SECONDARY | Mean Change in Central Foveal Volume | 12 months | Patients in cohort 2 did not complete the study. | mm^3 | MEAN |
| SECONDARY | Changes, by Disc Areas, of Capillary Non-perfusion in the Periphery | 12 months | Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246) | ||
| SECONDARY | Goldman Visual Field Changes | 12 months | Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246) |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in logMAR | Treatment Experienced (Cohort 1 | 0.91 | Full Range 0.4 to 1.42 | logMAR | |
| Incidence and Severity of Adverse Events (Ocular and Non-ocular). | Treatment Experienced (Cohort 1 | Ocular Events | 1 | incidents | |
| Incidence and Severity of Adverse Events (Ocular and Non-ocular). | Treatment Naive (Cohort 2) | Ocular Events | 0 | incidents | |
| Incidence and Severity of Adverse Events (Ocular and Non-ocular). | Treatment Experienced (Cohort 1 | Non-Ocular Events | 0 | incidents | |
| Incidence and Severity of Adverse Events (Ocular and Non-ocular). | Treatment Naive (Cohort 2) | Non-Ocular Events | 0 | incidents | |
| Incidence and Severity of Adverse Events (Ocular and Non-ocular). | Treatment Experienced (Cohort 1 | Serious Ocular Events | 0 | incidents | |
| Incidence and Severity of Adverse Events (Ocular and Non-ocular). | Treatment Naive (Cohort 2) | Serious Ocular Events | 0 | incidents | |
| Incidence and Severity of Adverse Events (Ocular and Non-ocular). | Treatment Experienced (Cohort 1 | Serious Non-Ocular Events | 0 | incidents | |
| Incidence and Severity of Adverse Events (Ocular and Non-ocular). | Treatment Naive (Cohort 2) | Serious Non-Ocular Events | 0 | incidents | |
| Neovascularization Development | Treatment Experienced (Cohort 1 | 0 | Percentage of patients |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Experienced (Cohort 1 | 6 | |
| Overall Study | STARTED | Treatment Naive (Cohort 2) | 2 | |
| Overall Study | COMPLETED | Treatment Experienced (Cohort 1 | 6 | |
| Overall Study | COMPLETED | Treatment Naive (Cohort 2) | 0 | |
| Overall Study | NOT COMPLETED | Treatment Experienced (Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Treatment Naive (Cohort 2) | 2 |
Source ClinicalTrials.gov
Adverse events2
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 | Increased cup to disk ratio | Eye disorders | Cohort 1 | 1 | 6 | |
| other | Increased cup to disk ratio | Eye disorders | Cohort 2 | 0 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | ||
| Total, all-cause mortality | Cohort 2 | ||
| Total, other adverse events | Cohort 1 | 1 | 6 |
| Total, other adverse events | Cohort 2 | 0 | 2 |
| Total, serious adverse events | Cohort 1 | 0 | 6 |
| Total, serious adverse events | Cohort 2 | 0 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25102193 | 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 |
|---|
| Cohort 1 vs Cohort 2: 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/NCT01225146
GET https://conductscience.org/api/trials/v1/NCT01225146/registered