Trial · NCT04777201
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
NCT04777201, Phase 3, Completed, Hoffmann-La Roche; results first posted 2025-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration. Trials, record NCT04777201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04777201
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
- NCT number
- NCT04777201
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,036 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Faricimab, Sham Procedure, Anti-VEGF Therapy
- First posted
- 2021-03-02
- Last updated
- 2025-10-24
- Other registries' IDs
- eudract:2020-004523-16
- Results first posted
- 2025-10-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) | This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. |
| Primary | Incidence of Ocular Adverse Events in the Fellow Eye | From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) | This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity, and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. |
| Primary | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) | This is an analysis of participants with at least one non-ocular (systemic) adverse event (AE). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. |
| Primary | Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye | Baseline and 1 year | Specular microscopy was performed for both eyes prior to application of any topical ophthalmic anesthetic, tonometry, or any other study treatment on the same day for the evaluation of corneal endothelial cell (CEC) density. The 1-year timepoint was defined as the earliest substudy visit closest to Week 52 occurring between Week 48 and Week 64. Data (from both study eye and fellow eye) collected after the fellow eye's use of prohibited therapies-such as faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation-were excluded from the corneal endothelial cell analysis. |
| Secondary | Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye | Baseline and Week 24 | Specular microscopy was performed for both eyes prior to application of any topical ophthalmic anesthetic, tonometry, or any other study treatment on the same day for the evaluation of corneal endothelial cell (CEC) density. The Week 24 timepoint was defined as the earliest substudy visit closest to Week 24 occurring between Week 20 and Week 28. Data (from both study eye and fellow eye) collected after the fellow eye's use of prohibited therapies-such as faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation-were excluded from the corneal endothelial cell analysis. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) | Safety-Evaluable Population: all participants who enrolled in the long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Ocular Adverse Events in the Fellow Eye | From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) | Safety-Evaluable Population: all participants who enrolled in the long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) | Safety-Evaluable Population: all participants who enrolled in the long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye | Baseline and 1 year | Modified Intent-to-Treat Population: All enrolled participants who received at least one injection of faricimab in the study eye during this substudy. Only participants who completed the Year 1 visit within the analysis window (Weeks 48 to 64) were included for analysis. | Percent change in cell density | MEAN |
| SECONDARY | Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye | Baseline and Week 24 | Modified Intent-to-Treat Population: All enrolled participants who received at least one injection of faricimab in the study eye during this substudy. Only participants who completed the midpoint visit within the analysis window (Weeks 20 to 28) were included for analysis. | Percent change in cell density | MEAN |
Source ClinicalTrials.gov
Results by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | Any Adverse Event (AE), Any Severity | 188 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | Any Adverse Event (AE), Any Severity | 207 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Substudy: Faricimab PTI | Any Adverse Event (AE), Any Severity | 16 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | AEs by Severity: Mild | 114 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | AEs by Severity: Mild | 106 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Substudy: Faricimab PTI | AEs by Severity: Mild | 11 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | AEs by Severity: Moderate | 58 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | AEs by Severity: Moderate | 75 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Substudy: Faricimab PTI | AEs by Severity: Moderate | 4 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | AEs by Severity: Severe | 13 | Participants |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study | STARTED | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 524 | |
| Main Study | STARTED | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 505 | |
| Main Study | STARTED | Substudy: Faricimab PTI | 0 | |
| Main Study | Safety-Evaluable Population | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 520 | |
| Main Study | Safety-Evaluable Population | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 505 | |
| Main Study | Safety-Evaluable Population | Substudy: Faricimab PTI | 0 | |
| Main Study | COMPLETED | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 453 | |
| Main Study | COMPLETED | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 415 | |
| Main Study | COMPLETED | Substudy: Faricimab PTI | 0 | |
| Main Study | NOT COMPLETED | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 71 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events708
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 | Cataract | Eye disorders | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 56 | 520 | 78 |
| other | Cataract | Eye disorders | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 63 | 505 | 80 |
| other | Cataract | Eye disorders | Substudy: Faricimab PTI | 2 | 113 | 2 |
| other | Neovascular age-related macular degeneration | Eye disorders | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 60 | 520 | 70 |
| other | Neovascular age-related macular degeneration | Eye disorders | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 55 | 505 | 65 |
| other | Neovascular age-related macular degeneration | Eye disorders | Substudy: Faricimab PTI | 2 | 113 | 3 |
| other | Posterior capsule opacification | Eye disorders | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 14 | 520 | 17 |
| other | Posterior capsule opacification | Eye disorders | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 26 | 505 | 30 |
| other | Posterior capsule opacification | Eye disorders | Substudy: Faricimab PTI | 1 | 113 | 1 |
| other | COVID-19 | Infections and infestations | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 61 | 520 | 65 |
1 to 10 of 708Source ClinicalTrials.gov
See all 708 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 13 | 520 |
| Total, all-cause mortality | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 27 | 505 |
| Total, all-cause mortality | Substudy: Faricimab PTI | 1 | 113 |
| Total, other adverse events | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 158 | 520 |
| Total, other adverse events | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 169 | 505 |
| Total, other adverse events | Substudy: Faricimab PTI | 9 | 113 |
| Total, serious adverse events | Main Study Cohort A: Faricimab PTI (Prior Faricimab) | 125 | 520 |
| Total, serious adverse events | Main Study Cohort B: Faricimab PTI (Prior Aflibercept) | 156 | 505 |
| Total, serious adverse events | Substudy: Faricimab PTI | 14 | 113 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04777201
GET https://conductscience.org/api/trials/v1/NCT04777201/results?page=2