Trial · NCT04126317
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
NCT04126317, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration. Trials, record NCT04126317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04126317
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
- NCT number
- NCT04126317
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 106 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Neovascular (Wet) Age-Related Macular Degeneration
- Interventions
- aflibercept, High-dose aflibercept
- First posted
- 2019-10-15
- Last updated
- 2023-08-14
- Results first posted
- 2023-08-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Up to Week 44 | |
| Primary | Number of Participants With at Least One Serious TEAE | Up to Week 44 | |
| Primary | Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye | At Week 16 | 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) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Up to Week 44 | Safety analysis set (SAF): All randomized participants who received any study drug; it was based on the treatment received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With at Least One Serious TEAE | Up to Week 44 | SAF: All randomized participants who received any study drug; it was based on the treatment received (as treated) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye | At Week 16 | 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). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Intravitreal Aflibercept Injection (IAI) | Participants with at least 1 Ocular TEAE of the Study Eye | 20 | Participants | |
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | High-Dose Aflibercept Injection (HD) | Participants with at least 1 Ocular TEAE of the Study Eye | 20 | Participants | |
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Intravitreal Aflibercept Injection (IAI) | Participants with at least 1 Ocular TEAE of the Fellow Eye | 13 | Participants | |
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | High-Dose Aflibercept Injection (HD) | Participants with at least 1 Ocular TEAE of the Fellow Eye | 13 | Participants | |
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Intravitreal Aflibercept Injection (IAI) | Participants with at least 1 Non-Ocular TEAE | 24 | Participants | |
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | High-Dose Aflibercept Injection (HD) | Participants with at least 1 Non-Ocular TEAE | 28 | Participants | |
| Number of Participants With at Least One Serious TEAE | Intravitreal Aflibercept Injection (IAI) | Participants with at least 1 Ocular Serious TEAE of the Study Eye | 1 | Participants | |
| Number of Participants With at Least One Serious TEAE | High-Dose Aflibercept Injection (HD) | Participants with at least 1 Ocular Serious TEAE of the Study Eye | 2 | Participants | |
| Number of Participants With at Least One Serious TEAE | Intravitreal Aflibercept Injection (IAI) | Participants with at least 1 Ocular Serious TEAE of the Fellow Eye | 0 | Participants | |
| Number of Participants With at Least One Serious TEAE | High-Dose Aflibercept Injection (HD) | Participants with at least 1 Ocular Serious TEAE of the Fellow Eye | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravitreal Aflibercept Injection (IAI) | 53 | |
| Overall Study | STARTED | High-Dose Aflibercept Injection (HD) | 53 | |
| Overall Study | COMPLETED | Intravitreal Aflibercept Injection (IAI) | 49 | |
| Overall Study | COMPLETED | High-Dose Aflibercept Injection (HD) | 51 | |
| Overall Study | NOT COMPLETED | Intravitreal Aflibercept Injection (IAI) | 4 | |
| Overall Study | NOT COMPLETED | High-Dose Aflibercept Injection (HD) | 2 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fall | Injury, poisoning and procedural complications | Intravitreal Aflibercept Injection (IAI) | 2 | 53 | 2 |
| other | Fall | Injury, poisoning and procedural complications | High-Dose Aflibercept Injection (HD) | 3 | 53 | 4 |
| other | Dizziness | Nervous system disorders | Intravitreal Aflibercept Injection (IAI) | 0 | 53 | 0 |
| other | Dizziness | Nervous system disorders | High-Dose Aflibercept Injection (HD) | 3 | 53 | 3 |
| other | Conjunctival haemorrhage Fellow Eye | Eye disorders | Intravitreal Aflibercept Injection (IAI) | 1 | 53 | 1 |
| other | Conjunctival haemorrhage Fellow Eye | Eye disorders | High-Dose Aflibercept Injection (HD) | 3 | 53 | 3 |
| other | Neovascular age-related macular degeneration Fellow Eye | Eye disorders | Intravitreal Aflibercept Injection (IAI) | 3 | 53 | 3 |
| other | Neovascular age-related macular degeneration Fellow Eye | Eye disorders | High-Dose Aflibercept Injection (HD) | 4 | 53 | 4 |
| other | Vitreous detachment Fellow Eye | Eye disorders | Intravitreal Aflibercept Injection (IAI) | 3 | 53 | 3 |
| other | Vitreous detachment Fellow Eye | Eye disorders | High-Dose Aflibercept Injection (HD) | 1 | 53 | 2 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravitreal Aflibercept Injection (IAI) | 0 | 53 |
| Total, all-cause mortality | High-Dose Aflibercept Injection (HD) | 1 | 53 |
| Total, other adverse events | Intravitreal Aflibercept Injection (IAI) | 14 | 53 |
| Total, other adverse events | High-Dose Aflibercept Injection (HD) | 19 | 53 |
| Total, serious adverse events | Intravitreal Aflibercept Injection (IAI) | 4 | 53 |
| Total, serious adverse events | High-Dose Aflibercept Injection (HD) | 7 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37535382 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intravitreal Aflibercept Injection (IAI) vs High-Dose Aflibercept Injection (HD): deaths from any cause | Trial comparisons |
| 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 |
| Intravitreal Aflibercept Injection (IAI) vs High-Dose Aflibercept Injection (HD): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04126317
GET https://conductscience.org/api/trials/v1/NCT04126317/events?page=2