Comparison · NCT02259088-sae
Ranibizumab (RFB002) vs Laser: 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. Ranibizumab (RFB002) vs Laser: serious adverse events. Trial comparisons, record NCT02259088-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02259088-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 | 0.186 | 0.146 | 0.233 | wilson | |
| Risk in group 2 | 0.2 | 0.125 | 0.304 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0143 | -0.126 | 0.0742 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.928 | 0.558 | 1.55 | log | |
| Odds ratio, group 1 over group 2 | 0.912 | 0.483 | 1.72 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ranibizumab (RFB002) than on Laser | 69.8 | 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 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | 57 | 307 | EG000 |
| Group 2 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections | 15 | 75 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 through study completion, an average of 1 year
Source ClinicalTrials.gov
Trial
- Title
- A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
- NCT number
- NCT02259088
- Phases
- PHASE3
- Conditions
- Diabetic Macular Edema, Visual Impairment
- Interventions
- Ranibizumab (RFB002), Laser, Sham injection, Sham laser
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2019-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02259088?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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