Trial · NCT01003106
Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
NCT01003106, Phase 1, Phase 2, Completed, Peter A Campochiaro, MD; results first posted 2016-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions. Trials, record NCT01003106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01003106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
- NCT number
- NCT01003106
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Peter A Campochiaro, MD
- Conditions
- Retinal Vein Occlusion
- Interventions
- Ranibizumab 0.5mg (monthly), Ranibizumab 2.0mg (monthly), Pro re nata (prn) ranibizumab, Pro re nata (prn) Laser photocoagulation
- First posted
- 2009-10-28
- Last updated
- 2016-03-15
- Results first posted
- 2016-03-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Ocular and Non-ocular Adverse Events. | 36 months | |
| Secondary | Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | Baseline to month 6 | |
| Secondary | Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | Month 6- Month 36 | |
| Secondary | Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | Baseline to month 6 | |
| Secondary | Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | Month 6- Month 36 |
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 | Incidence and Severity of Ocular and Non-ocular Adverse Events. | 36 months | participants | NUMBER | |
| SECONDARY | Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | Baseline to month 6 | Letters | MEAN | |
| SECONDARY | Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | Month 6- Month 36 | Letters | MEAN | |
| SECONDARY | Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | Baseline to month 6 | microns | MEAN | |
| SECONDARY | Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | Month 6- Month 36 | microns | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence and Severity of Ocular and Non-ocular Adverse Events. | BRVO | Patients with Serious Adverse Events | 17 | participants | |
| Incidence and Severity of Ocular and Non-ocular Adverse Events. | CRVO | Patients with Serious Adverse Events | 12 | participants | |
| Incidence and Severity of Ocular and Non-ocular Adverse Events. | BRVO | Patient with (non serious) adverse events | 37 | participants | |
| Incidence and Severity of Ocular and Non-ocular Adverse Events. | CRVO | Patient with (non serious) adverse events | 35 | participants | |
| Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | BRVO-Ranibizumab 0.5mg Alone | 12.1 | Standard Error 2.9 | Letters | |
| Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | BRVO- Ranibizumab 2.0mg Alone | 14.6 | Standard Error 2.3 | Letters | |
| Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | CRVO- Ranibizumab 0.5mg Alone | 15.5 | Standard Error 2.4 | Letters | |
| Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | CRVO- Ranibizumab 2.0mg Alone | 15.8 | Standard Error 2.4 | Letters | |
| Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | BRVO- Pro re Nata (Prn) Ranibizumab Alone | 3.1 | Standard Error 3.3 | Letters | |
| Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation | -2.6 | Standard Error 2.2 | Letters |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline to Month 6 | STARTED | BRVO- Ranibizumab 0.5mg Alone | 22 | |
| Baseline to Month 6 | STARTED | BRVO- Ranibizumab 2.0mg Alone | 20 | |
| Baseline to Month 6 | STARTED | BRVO- Pro re Nata (Prn) Ranibizumab Alone | 0 | |
| Baseline to Month 6 | STARTED | BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation | 0 | |
| Baseline to Month 6 | STARTED | CRVO- Ranibizumab 0.5mg Alone | 19 | |
| Baseline to Month 6 | STARTED | CRVO- Ranibizumab 2.0mg Alone | 20 | |
| Baseline to Month 6 | STARTED | CRVO- Pro re Nata (Prn) Ranibizumab Alone | 0 | |
| Baseline to Month 6 | STARTED | CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation | 0 | |
| Baseline to Month 6 | COMPLETED | BRVO- Ranibizumab 0.5mg Alone | 22 | |
| Baseline to Month 6 | COMPLETED | BRVO- Ranibizumab 2.0mg Alone | 20 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events94
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 IOP | Eye disorders | BRVO | 2 | 42 | 2 |
| other | Increased IOP | Eye disorders | CRVO | 0 | 39 | 0 |
| other | Tooth Extraction | General disorders | BRVO | 3 | 42 | 3 |
| other | Tooth Extraction | General disorders | CRVO | 0 | 39 | 0 |
| other | Skin Lesion/Skin Rash | Skin and subcutaneous tissue disorders | BRVO | 4 | 42 | 4 |
| other | Skin Lesion/Skin Rash | Skin and subcutaneous tissue disorders | CRVO | 0 | 39 | 0 |
| other | Diarrhea | Gastrointestinal disorders | BRVO | 2 | 42 | 2 |
| other | Diarrhea | Gastrointestinal disorders | CRVO | 0 | 39 | 0 |
| other | Nausea/Vomiting | Gastrointestinal disorders | BRVO | 4 | 42 | 4 |
| other | Nausea/Vomiting | Gastrointestinal disorders | CRVO | 0 | 39 | 0 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BRVO | ||
| Total, all-cause mortality | CRVO | ||
| Total, other adverse events | BRVO | 37 | 42 |
| Total, other adverse events | CRVO | 35 | 39 |
| Total, serious adverse events | BRVO | 17 | 42 |
| Total, serious adverse events | CRVO | 12 | 39 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BRVO vs CRVO: 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/NCT01003106
GET https://conductscience.org/api/trials/v1/NCT01003106/flow?page=2