Trial · NCT01521559
Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
NCT01521559, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2014-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO). Trials, record NCT01521559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01521559
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
- NCT number
- NCT01521559
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 183 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Branch Retinal Vein Occlusion
- Interventions
- Macular Laser Photocoagulation, Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
- First posted
- 2012-01-30
- Last updated
- 2014-11-13
- Results first posted
- 2014-11-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF | Baseline to week 24 | Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data. |
| Secondary | Change From Baseline to Week 24 in BCVA Score - LOCF | Baseline to Week 24 | Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data. |
| Secondary | Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF | Baseline to week 24 | CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT). |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF | Baseline to week 24 | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF | Baseline to week 24 | FAS | participants | NUMBER |
| SECONDARY | Change From Baseline to Week 24 in BCVA Score - LOCF | Baseline to Week 24 | FAS | letters correctly read | MEAN |
| SECONDARY | Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF | Baseline to week 24 | FAS | microns | MEAN |
| SECONDARY | Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF | Baseline to week 24 | FAS | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF | Macular Laser Photocoagulation Treatment (Control) | 24 | participants | ||
| Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 48 | participants | ||
| Change From Baseline to Week 24 in BCVA Score - LOCF | Macular Laser Photocoagulation Treatment (Control) | 6.9 | Standard Deviation 12.91 | letters correctly read | |
| Change From Baseline to Week 24 in BCVA Score - LOCF | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 17.0 | Standard Deviation 11.88 | letters correctly read | |
| Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF | Macular Laser Photocoagulation Treatment (Control) | -128.0 | Standard Deviation 195.02 | microns | |
| Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | -280.5 | Standard Deviation 189.7 | microns | |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF | Macular Laser Photocoagulation Treatment (Control) | 6.3 | Standard Deviation 12.34 | scores on a scale | |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 7.7 | Standard Deviation 11.08 | scores on a scale |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macular Laser Photocoagulation Treatment (Control) | 92 | |
| Overall Study | STARTED | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 91 | |
| Overall Study | Completed Week 24 | Macular Laser Photocoagulation Treatment (Control) | 83 | |
| Overall Study | Completed Week 24 | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 85 | |
| Overall Study | Completed Week 52 | Macular Laser Photocoagulation Treatment (Control) | 77 | |
| Overall Study | Completed Week 52 | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 73 | |
| Overall Study | COMPLETED | Macular Laser Photocoagulation Treatment (Control) | 77 | |
| Overall Study | COMPLETED | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 73 | |
| Overall Study | NOT COMPLETED | Macular Laser Photocoagulation Treatment (Control) | 15 | |
| Overall Study | NOT COMPLETED | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 18 |
Source ClinicalTrials.gov
Adverse events104
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 | Blood pressure increased | Investigations | Macular Laser Photocoagulation Treatment (Control) | 5 | 92 | |
| other | Blood pressure increased | Investigations | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 4 | 91 | |
| other | Bronchitis | Infections and infestations | Macular Laser Photocoagulation Treatment (Control) | 2 | 92 | |
| other | Bronchitis | Infections and infestations | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 6 | 91 | |
| other | Conjunctival haemorrhage | Eye disorders | Macular Laser Photocoagulation Treatment (Control) | 14 | 92 | |
| other | Conjunctival haemorrhage | Eye disorders | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 22 | 91 | |
| other | Eye irritation | Eye disorders | Macular Laser Photocoagulation Treatment (Control) | 1 | 92 | |
| other | Eye irritation | Eye disorders | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 7 | 91 | |
| other | Eye pain | Eye disorders | Macular Laser Photocoagulation Treatment (Control) | 7 | 92 | |
| other | Eye pain | Eye disorders | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 5 | 91 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macular Laser Photocoagulation Treatment (Control) | ||
| Total, all-cause mortality | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | ||
| Total, other adverse events | Macular Laser Photocoagulation Treatment (Control) | 30 | 92 |
| Total, other adverse events | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 25 | 91 |
| Total, serious adverse events | Macular Laser Photocoagulation Treatment (Control) | 10 | 92 |
| Total, serious adverse events | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 13 | 91 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32633861 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Macular Laser Photocoagulation Treatment (Control) vs Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321): Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF | Trial comparisons |
| Macular Laser Photocoagulation Treatment (Control) vs Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321): serious adverse events | 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/NCT01521559
GET https://conductscience.org/api/trials/v1/NCT01521559/events?page=2