Trial · NCT04432831
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
NCT04432831, Phase 3, Completed, Hoffmann-La Roche; results first posted 2024-10-30
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 Diabetic Macular Edema. Trials, record NCT04432831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04432831
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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 Diabetic Macular Edema
- NCT number
- NCT04432831
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,479 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Diabetic Macular Edema
- Interventions
- Faricimab, Sham Procedure
- First posted
- 2020-06-16
- Last updated
- 2026-02-09
- Other registries' IDs
- eudract:2020-000402-29
- Results first posted
- 2024-10-30
Source ClinicalTrials.gov
Registered outcomes3
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 day of the first dose of faricimab until the end of the study (up to 108 weeks) | 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 day of the first dose of faricimab until the end of the study (up to 108 weeks) | This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the fellow eye (i.e., non-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 day of the first dose of faricimab until the end of the study (up to 108 weeks) | 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. |
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 | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | From the day of the first dose of faricimab until the end of the study (up to 108 weeks) | The Safety-Evaluable Population included all participants who enrolled in this long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE. A total of 10 participants who were enrolled in the study but did not receive treatment with faricimab were excluded from the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Ocular Adverse Events in the Fellow Eye | From the day of the first dose of faricimab until the end of the study (up to 108 weeks) | The Safety-Evaluable Population included all participants who enrolled in this long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE. A total of 10 participants who were enrolled in the study but did not receive treatment with faricimab were excluded from the analysis. | 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 day of the first dose of faricimab until the end of the study (up to 108 weeks) | The Safety-Evaluable Population included all participants who enrolled in this long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE. A total of 10 participants who were enrolled in the study but did not receive treatment with faricimab were excluded from the analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group90
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 | Faricimab PTI (Prior Faricimab Q8W) | Any Adverse Event (AE), Any Severity | 219 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Faricimab PTI (Prior Faricimab PTI) | 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 | Faricimab PTI (Prior Aflibercept Q8W) | Any Adverse Event (AE), Any Severity | 197 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Faricimab PTI (Prior Faricimab Q8W) | AE by Severity: Mild | 119 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Faricimab PTI (Prior Faricimab PTI) | AE by Severity: Mild | 109 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Faricimab PTI (Prior Aflibercept Q8W) | AE by Severity: Mild | 109 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Faricimab PTI (Prior Faricimab Q8W) | AE by Severity: Moderate | 74 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Faricimab PTI (Prior Faricimab PTI) | AE by Severity: Moderate | 66 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Faricimab PTI (Prior Aflibercept Q8W) | AE by Severity: Moderate | 74 | Participants | |
| Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Faricimab PTI (Prior Faricimab Q8W) | AE by Severity: Severe | 20 | Participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Faricimab PTI (Prior Faricimab Q8W) | 493 | |
| Overall Study | STARTED | Faricimab PTI (Prior Faricimab PTI) | 506 | |
| Overall Study | STARTED | Faricimab PTI (Prior Aflibercept Q8W) | 475 | |
| Overall Study | Received at Least One Dose of Study Drug | Faricimab PTI (Prior Faricimab Q8W) | 491 | |
| Overall Study | Received at Least One Dose of Study Drug | Faricimab PTI (Prior Faricimab PTI) | 500 | |
| Overall Study | Received at Least One Dose of Study Drug | Faricimab PTI (Prior Aflibercept Q8W) | 473 | |
| Overall Study | COMPLETED | Faricimab PTI (Prior Faricimab Q8W) | 405 | |
| Overall Study | COMPLETED | Faricimab PTI (Prior Faricimab PTI) | 407 | |
| Overall Study | COMPLETED | Faricimab PTI (Prior Aflibercept Q8W) | 392 | |
| Overall Study | NOT COMPLETED | Faricimab PTI (Prior Faricimab Q8W) | 88 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events987
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 | Faricimab PTI (Prior Faricimab Q8W) | 65 | 491 | 65 |
| other | Cataract | Eye disorders | Faricimab PTI (Prior Faricimab PTI) | 60 | 500 | 60 |
| other | Cataract | Eye disorders | Faricimab PTI (Prior Aflibercept Q8W) | 63 | 473 | 63 |
| other | Diabetic retinal oedema | Eye disorders | Faricimab PTI (Prior Faricimab Q8W) | 22 | 491 | 22 |
| other | Diabetic retinal oedema | Eye disorders | Faricimab PTI (Prior Faricimab PTI) | 27 | 500 | 31 |
| other | Diabetic retinal oedema | Eye disorders | Faricimab PTI (Prior Aflibercept Q8W) | 24 | 473 | 27 |
| other | Posterior capsule opacification | Eye disorders | Faricimab PTI (Prior Faricimab Q8W) | 16 | 491 | 17 |
| other | Posterior capsule opacification | Eye disorders | Faricimab PTI (Prior Faricimab PTI) | 17 | 500 | 17 |
| other | Posterior capsule opacification | Eye disorders | Faricimab PTI (Prior Aflibercept Q8W) | 14 | 473 | 14 |
| other | COVID-19 | Infections and infestations | Faricimab PTI (Prior Faricimab Q8W) | 63 | 491 | 70 |
1 to 10 of 987Source ClinicalTrials.gov
See all 987 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Faricimab PTI (Prior Faricimab Q8W) | 23 | 493 |
| Total, all-cause mortality | Faricimab PTI (Prior Faricimab PTI) | 23 | 506 |
| Total, all-cause mortality | Faricimab PTI (Prior Aflibercept Q8W) | 17 | 475 |
| Total, other adverse events | Faricimab PTI (Prior Faricimab Q8W) | 233 | 491 |
| Total, other adverse events | Faricimab PTI (Prior Faricimab PTI) | 213 | 500 |
| Total, other adverse events | Faricimab PTI (Prior Aflibercept Q8W) | 219 | 473 |
| Total, serious adverse events | Faricimab PTI (Prior Faricimab Q8W) | 158 | 491 |
| Total, serious adverse events | Faricimab PTI (Prior Faricimab PTI) | 124 | 500 |
| Total, serious adverse events | Faricimab PTI (Prior Aflibercept Q8W) | 134 | 473 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT04432831
GET https://conductscience.org/api/trials/v1/NCT04432831/results?page=2