Comparison · NCT03203447-sae
Active vs Control: 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. Active vs Control: serious adverse events. Trial comparisons, record NCT03203447-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03203447-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 | 0.00625 | 0.0011 | 0.0345 | wilson | |
| Risk in group 2 | 0.0185 | 0.00632 | 0.053 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0123 | -0.0472 | 0.0185 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.338 | 0.0355 | 3.21 | log | |
| Odds ratio, group 1 over group 2 | 0.333 | 0.0343 | 3.24 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Active than on Control | 81.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Active | Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin | 1 | 160 | EG000 |
| Group 2 | Control | Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure~suprachoroidal sham: sham suprachoroidal procedure~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin | 3 | 162 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected through follow-up and study completion, approximately 6 months.
Source ClinicalTrials.gov
Trial
- Title
- Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
- NCT number
- NCT03203447
- Phases
- PHASE3
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Interventions
- suprachoroidal CLS-TA, suprachoroidal sham, Lucentis or Avastin
- Lead sponsor
- Clearside Biomedical, Inc.
- Results first posted
- 2021-04-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03203447?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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