Comparison · NCT01521559-sae
Macular Laser Photocoagulation Treatment (Control) vs Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Macular Laser Photocoagulation Treatment (Control) vs Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321): serious adverse events. Trial comparisons, record NCT01521559-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01521559-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.109 | 0.0601 | 0.189 | wilson | |
| Risk in group 2 | 0.143 | 0.0854 | 0.229 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0342 | -0.133 | 0.0643 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.761 | 0.352 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 0.732 | 0.303 | 1.77 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Macular Laser Photocoagulation Treatment (Control) than on Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 29.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Macular Laser Photocoagulation Treatment (Control) | Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing. | 10 | 92 | EG000 |
| Group 2 | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36. | 13 | 91 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through Week 52 (end of study)
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Branch Retinal Vein Occlusion
- Interventions
- Macular Laser Photocoagulation, Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2014-11-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01521559?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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