Comparison · NCT04126317-ebf1d2f6
Intravitreal Aflibercept Injection (IAI) vs High-Dose Aflibercept Injection (HD): Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Intravitreal Aflibercept Injection (IAI) vs High-Dose Aflibercept Injection (HD): Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye. Trial comparisons, record NCT04126317-ebf1d2f6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04126317-ebf1d2f6
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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 | 0.34 | 0.227 | 0.474 | wilson | |
| Risk in group 2 | 0.509 | 0.379 | 0.639 | wilson | |
| Risk difference, group 1 minus group 2 | -0.17 | -0.341 | 0.0176 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.421 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.495 | 0.226 | 1.08 | log | |
| Number needed to treat, for one fewer participant with the outcome on Intravitreal Aflibercept Injection (IAI) than on High-Dose Aflibercept Injection (HD) | 5.89 | 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. | 18 | 53 | OG000 |
| 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. | 27 | 53 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
- Description
Center subfield=the circular area in 1 millimeter (mm) diameter centered around the center point of the fovea. Without fluid defined as absence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the center subfield. Presence of retinal fluid was assessed by spectral domain optical coherence tomography (SD-OCT)
- Time frame
- At Week 16
- Population
Full analysis set (FAS): All randomized participants; it was based on the treatment allocated (as randomized). Missing post-baseline values for a given participant were imputed using the last observation carried forward (LOCF).
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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