Trial · NCT01599650
Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
NCT01599650, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-11-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion. Trials, record NCT01599650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01599650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
- NCT number
- NCT01599650
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 455 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Branch Retinal Vein Occlusion
- Interventions
- Ranibizumab, Laser
- First posted
- 2012-05-16
- Last updated
- 2016-11-10
- Other registries' IDs
- eudract:2011-002859-34
- Results first posted
- 2016-11-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Baseline, 6 Months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model. |
| Secondary | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Baseline, 24 Months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients. |
| Secondary | Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group | Day 1 through Month 23 | Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data. |
| Secondary | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | From Baseline through Month 6 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients. |
| Secondary | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Baseline, Month 12 and Month 24 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model. |
| Secondary | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | Baseline, Month 6 and Month 24 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 \& Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups). |
| Secondary | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | Month 6 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome. |
| Secondary | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | Month 24 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome. |
| Secondary | The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | Month 12 and Month 24 | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity \& analysis was based on analysis of variance (ANOVA) |
| Secondary | The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | Months 6 and 24 | The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Baseline, 6 Months | analysis for change consists of the group that had a baseline and 6 month data point | letters | MEAN |
| SECONDARY | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Baseline, 24 Months | analysis for change consists of the group that had a baseline and 24 month data point | letters | MEAN |
| SECONDARY | Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group | Day 1 through Month 23 | treatments | MEAN | |
| SECONDARY | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | From Baseline through Month 6 | letters | MEAN | |
| SECONDARY | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Baseline, Month 12 and Month 24 | Full Analysis set | letters | MEAN |
| SECONDARY | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | Baseline, Month 6 and Month 24 | percent patients gaining improvement | NUMBER | |
| SECONDARY | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | Month 6 | participants | NUMBER | |
| SECONDARY | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | Month 24 | participants | NUMBER | |
| SECONDARY | The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | Month 12 and Month 24 | microns | MEAN | |
| SECONDARY | The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | Months 6 and 24 | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group125
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 1-ranibizumab Monotherapy | Baseline | 59.5 | Standard Deviation 11.78 | letters |
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 2-ranibizumab With Laser | Baseline | 56.6 | Standard Deviation 13.19 | letters |
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 3-laser Monotherapy | Baseline | 56.8 | Standard Deviation 13.86 | letters |
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 1-ranibizumab Monotherapy | Month 6 | 74.3 | Standard Deviation 12.27 | letters |
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 2-ranibizumab With Laser | Month 6 | 71.4 | Standard Deviation 14.43 | letters |
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 3-laser Monotherapy | Month 6 | 62.8 | Standard Deviation 14.08 | letters |
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 1-ranibizumab Monotherapy | Change from Baseline atMonth 6 | 14.8 | Standard Deviation 10.70 | letters |
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 2-ranibizumab With Laser | Change from Baseline atMonth 6 | 14.8 | Standard Deviation 11.13 | letters |
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | 3-laser Monotherapy | Change from Baseline atMonth 6 | 6.0 | Standard Deviation 14.27 | letters |
| The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | 1-ranibizumab Monotherapy | Baseline | 59.5 | Standard Deviation 11.78 | letters |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1-ranibizumab Monotherapy | 183 | |
| Overall Study | STARTED | 2-ranibizumab With Laser | 180 | |
| Overall Study | STARTED | 3-laser Monotherapy | 92 | |
| Overall Study | Completed 6 Mos | 1-ranibizumab Monotherapy | 174 | |
| Overall Study | Completed 6 Mos | 2-ranibizumab With Laser | 170 | |
| Overall Study | Completed 6 Mos | 3-laser Monotherapy | 80 | |
| Overall Study | COMPLETED | 1-ranibizumab Monotherapy | 161 | |
| Overall Study | COMPLETED | 2-ranibizumab With Laser | 154 | |
| Overall Study | COMPLETED | 3-laser Monotherapy | 65 | |
| Overall Study | NOT COMPLETED | 1-ranibizumab Monotherapy | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events688
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 | Vertigo | Ear and labyrinth disorders | Ranibizumab 0.5mg | 3 | 180 | |
| other | Vertigo | Ear and labyrinth disorders | Ranibizumab 0.5mg + Laser | 1 | 183 | |
| other | Vertigo | Ear and labyrinth disorders | Laser Monotherapy With Ranibizumab 0.5 mg From Month 6 | 2 | 63 | |
| other | Vertigo | Ear and labyrinth disorders | Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6 | 0 | 25 | |
| other | Blepharitis (Fellow untreated eye) | Eye disorders | Ranibizumab 0.5mg | 2 | 180 | |
| other | Blepharitis (Fellow untreated eye) | Eye disorders | Ranibizumab 0.5mg + Laser | 11 | 183 | |
| other | Blepharitis (Fellow untreated eye) | Eye disorders | Laser Monotherapy With Ranibizumab 0.5 mg From Month 6 | 0 | 63 | |
| other | Blepharitis (Fellow untreated eye) | Eye disorders | Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6 | 0 | 25 | |
| other | Blepharitis (Study eye) | Eye disorders | Ranibizumab 0.5mg | 3 | 180 | |
| other | Blepharitis (Study eye) | Eye disorders | Ranibizumab 0.5mg + Laser | 11 | 183 |
1 to 10 of 688Source ClinicalTrials.gov
See all 688 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab 0.5mg | ||
| Total, all-cause mortality | Ranibizumab 0.5mg + Laser | ||
| Total, all-cause mortality | Laser Monotherapy With Ranibizumab 0.5 mg From Month 6 | ||
| Total, all-cause mortality | Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6 | ||
| Total, other adverse events | Ranibizumab 0.5mg | 112 | 180 |
| Total, other adverse events | Ranibizumab 0.5mg + Laser | 121 | 183 |
| Total, other adverse events | Laser Monotherapy With Ranibizumab 0.5 mg From Month 6 | 40 | 63 |
| Total, other adverse events | Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6 | 14 | 25 |
| Total, serious adverse events | Ranibizumab 0.5mg | 30 | 180 |
| Total, serious adverse events | Ranibizumab 0.5mg + Laser | 33 | 183 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01599650
GET https://conductscience.org/api/trials/v1/NCT01599650/results?page=2