Comparison · NCT04126317-sae
Intravitreal Aflibercept Injection (IAI) vs High-Dose Aflibercept Injection (HD): 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. Intravitreal Aflibercept Injection (IAI) vs High-Dose Aflibercept Injection (HD): serious adverse events. Trial comparisons, record NCT04126317-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04126317-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 | 0.0755 | 0.0297 | 0.179 | wilson | |
| Risk in group 2 | 0.132 | 0.0655 | 0.248 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0566 | -0.182 | 0.0661 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.571 | 0.178 | 1.84 | log | |
| Odds ratio, group 1 over group 2 | 0.536 | 0.147 | 1.95 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Intravitreal Aflibercept Injection (IAI) than on High-Dose Aflibercept Injection (HD) | 17.7 | 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 | Intravitreal Aflibercept Injection (IAI) | Treatment-naïve participants with neovascular wet age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32. | 4 | 53 | EG000 |
| Group 2 | High-Dose Aflibercept Injection (HD) | Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32. | 7 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose up to Week 44 (end of study)
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
- NCT number
- NCT04126317
- Phases
- PHASE2
- Conditions
- Neovascular (Wet) Age-Related Macular Degeneration
- Interventions
- aflibercept, High-dose aflibercept
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2023-08-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04126317?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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