Diabetic Macular Edema
Conditions
Brief summary
This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.
Interventions
DRUGFaricimab
Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.
OTHERSham Procedure
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The first 16 weeks of this study will be a masked period (to transition from the multi-arm parent studies) during which participants may receive either faricimab or sham injection. Participants and physicians will be masked only to the faricimab treatment interval. After the Week 16 treatment procedure, this study will follow an open-label design. The BCVA examiner will remain masked for the duration of this long-term extension study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation * Ability to comply with the study protocol, in the investigator's judgment * For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Exclusion criteria
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection of faricimab * Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications * Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications * History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study * Requirement for continuous use of any medications or treatments indicated as prohibited therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Participant flow
Pre-assignment details
A total of 1479 patients were enrolled, but 5 participants in total were excluded from the analysis populations because of Good Clinical Practice (GCP) non-compliance at a single site.
Participants by arm
| Arm | Count |
|---|---|
| Faricimab PTI (Prior Faricimab Q8W) This analysis group includes participants who were previously randomized to Arm A (faricimab 6 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen. | 493 |
| Faricimab PTI (Prior Faricimab PTI) This analysis group includes participants who were previously randomized to Arm B (faricimab 6 mg PTI) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen. | 506 |
| Faricimab PTI (Prior Aflibercept Q8W) This analysis group includes participants who were previously randomized to Arm C (aflibercept 2 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen. | 475 |
| Total | 1,474 |
Baseline characteristics
| Characteristic | Faricimab PTI (Prior Faricimab Q8W) | Faricimab PTI (Prior Faricimab PTI) | Faricimab PTI (Prior Aflibercept Q8W) | Total |
|---|---|---|---|---|
| Age, Continuous | 63.4 Years STANDARD_DEVIATION 9.9 | 64.0 Years STANDARD_DEVIATION 9.8 | 63.5 Years STANDARD_DEVIATION 9.4 | 63.6 Years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 68 Participants | 87 Participants | 79 Participants | 234 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 415 Participants | 408 Participants | 386 Participants | 1209 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 11 Participants | 10 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 4 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) Asian | 54 Participants | 52 Participants | 45 Participants | 151 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 32 Participants | 25 Participants | 84 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 12 Participants | 11 Participants | 36 Participants |
| Race (NIH/OMB) White | 392 Participants | 406 Participants | 389 Participants | 1187 Participants |
| Sex: Female, Male Female | 191 Participants | 184 Participants | 205 Participants | 580 Participants |
| Sex: Female, Male Male | 302 Participants | 322 Participants | 270 Participants | 894 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 23 / 493 | 23 / 506 | 17 / 475 |
| other Total, other adverse events | 233 / 491 | 213 / 500 | 219 / 473 |
| serious Total, serious adverse events | 158 / 491 | 124 / 500 | 134 / 473 |
Outcome results
Primary
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
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.
Time frame: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE Leading to Withdrawal from Study Treatment | 2 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Any AE of Special Interest (AESI) | 0 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Drop in Visual Acuity Score ≥30 Letters | 0 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Elevated ALT or AST with Either Elevated Bilirubin or Clinical Jaundice | 0 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Moderate | 124 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Any Adverse Event (AE), Any Severity | 317 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Severe | 102 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Serious Adverse Event (SAE) | 122 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Mild | 91 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Any Adverse Event (AE), Any Severity | 295 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Moderate | 124 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Any AE of Special Interest (AESI) | 0 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Mild | 94 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE Leading to Withdrawal from Study Treatment | 7 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Drop in Visual Acuity Score ≥30 Letters | 0 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Elevated ALT or AST with Either Elevated Bilirubin or Clinical Jaundice | 0 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Serious Adverse Event (SAE) | 100 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Severe | 77 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Elevated ALT or AST with Either Elevated Bilirubin or Clinical Jaundice | 0 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Any Adverse Event (AE), Any Severity | 297 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Mild | 97 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Moderate | 115 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Severe | 85 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Serious Adverse Event (SAE) | 112 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AE Leading to Withdrawal from Study Treatment | 4 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | Any AE of Special Interest (AESI) | 1 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Drop in Visual Acuity Score ≥30 Letters | 1 Participants |
Primary
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
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.
Time frame: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Intervention Required to Prevent Permanent Vision Loss | 6 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Drop in Visual Acuity Score ≥30 Letters | 23 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Serious Adverse Event (SAE) | 31 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Mild | 119 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Any AE of Special Interest (AESI) | 30 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE Leading to Withdrawal from Study Treatment | 3 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Treatment-related SAE | 0 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Treatment-related AE | 10 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Moderate | 74 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Any Adverse Event (AE), Any Severity | 219 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Associated with Severe IOI | 1 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Severe | 20 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Suspected Transmission of Infectious Agent by Study Drug | 0 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Missing | 6 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Drop in Visual Acuity Score ≥30 Letters | 10 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Any Adverse Event (AE), Any Severity | 188 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Mild | 109 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Moderate | 66 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Severe | 10 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Missing | 3 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Serious Adverse Event (SAE) | 15 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE Leading to Withdrawal from Study Treatment | 0 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Treatment-related AE | 10 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Treatment-related SAE | 1 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Any AE of Special Interest (AESI) | 14 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Associated with Severe IOI | 1 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Intervention Required to Prevent Permanent Vision Loss | 3 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Suspected Transmission of Infectious Agent by Study Drug | 0 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Intervention Required to Prevent Permanent Vision Loss | 3 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Any AE of Special Interest (AESI) | 24 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Missing | 2 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Mild | 109 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Drop in Visual Acuity Score ≥30 Letters | 20 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Moderate | 74 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE by Severity: Severe | 12 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Associated with Severe IOI | 1 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Any Adverse Event (AE), Any Severity | 197 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Treatment-related AE | 11 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AE Leading to Withdrawal from Study Treatment | 6 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | AESI: Suspected Transmission of Infectious Agent by Study Drug | 0 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Treatment-related SAE | 1 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale | Serious Adverse Event (SAE) | 26 Participants |
Primary
Incidence of Ocular Adverse Events in the Fellow Eye
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.
Time frame: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faricimab PTI (Prior Faricimab Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | Any Adverse Event (AE) | 186 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Associated with Severe IOI | 0 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | Any AE of Special Interest (AESI) | 13 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Drop in Visual Acuity Score ≥30 Letters | 6 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Suspected Transmission of Infectious Agent by Study Drug | 0 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Intervention Required to Prevent Permanent Vision Loss | 7 Participants |
| Faricimab PTI (Prior Faricimab Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | Serious Adverse Event (SAE) | 16 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence of Ocular Adverse Events in the Fellow Eye | Any AE of Special Interest (AESI) | 16 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Drop in Visual Acuity Score ≥30 Letters | 9 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence of Ocular Adverse Events in the Fellow Eye | Any Adverse Event (AE) | 185 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence of Ocular Adverse Events in the Fellow Eye | Serious Adverse Event (SAE) | 17 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Associated with Severe IOI | 1 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Intervention Required to Prevent Permanent Vision Loss | 6 Participants |
| Faricimab PTI (Prior Faricimab PTI) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Suspected Transmission of Infectious Agent by Study Drug | 0 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Associated with Severe IOI | 1 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | Any Adverse Event (AE) | 179 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Suspected Transmission of Infectious Agent by Study Drug | 0 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Intervention Required to Prevent Permanent Vision Loss | 4 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | AESI: Drop in Visual Acuity Score ≥30 Letters | 10 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | Serious Adverse Event (SAE) | 15 Participants |
| Faricimab PTI (Prior Aflibercept Q8W) | Incidence of Ocular Adverse Events in the Fellow Eye | Any AE of Special Interest (AESI) | 14 Participants |