Phase 3
N=553
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
Macular Edema · Branch Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT04740905 ↗Enrolled (actual)
553
Serious AEs
7.7%
Results posted
Jan 2024
Primary outcome: Primary: Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 — 16.9; 17.5 ETDRS Letters — p=0.4978
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Faricimab (Drug); Aflibercept (Drug); Sham Procedure (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 |
16.9; 17.5 | 0.4978 |
| SECONDARY Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 |
11.5; 12.4; 13.7; 15.1; 15.1; 15.9 | — |
| SECONDARY Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24 |
56.1; 60.4 | — |
| SECONDARY Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
34.3; 36.9; 41.2; 46.7; 51.0; 52.1 | — |
| SECONDARY Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
57.5; 59.2; 69.1; 69.0; 75.0; 74.8 | — |
| SECONDARY Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
75.7; 79.1; 84.0; 88.1; 87.0; 87.0 | — |
| SECONDARY Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
90.2; 93.2; 92.7; 96.8; 94.9; 94.2 | — |
| SECONDARY Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
99.3; 98.9; 99.3; 98.9; 99.3; 98.9 | — |
| SECONDARY Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
98.5; 98.9; 98.5; 98.9; 98.5; 98.9 | — |
| SECONDARY Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
97.1; 98.6; 97.8; 98.6; 97.8; 98.9 | — |
| SECONDARY Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24 |
8.7; 8.6; 14.1; 15.5; 15.6; 20.2 | — |
| SECONDARY Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24 |
55.6; 62.3; 63.9; 70.3; 69.0; 69.2 | — |
| SECONDARY Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24 |
3.6; 1.5; 3.2; 1.9; 2.3; 1.5 | — |
| SECONDARY Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24 |
-283.9; -281.1; -299.4; -296.9; -304.4; -298.8 | — |
| SECONDARY Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24 |
88.8; 88.1; 94.5; 93.2; 96.4; 92.1 | — |
| SECONDARY Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
46.1; 54.8; 53.8; 57.4; 65.3; 56.6 | — |
| SECONDARY Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
76.1; 72.9; 93.1; 91.4; 96.4; 97.1 | — |
| SECONDARY Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
37.8; 40.8; 50.9; 54.1; 63.8; 56.3 | — |
| SECONDARY Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24 |
5.6; 5.9 | — |
| SECONDARY Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72 |
11.5; 12.4; 13.7; 15.1; 15.1; 15.9 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
34.3; 36.9; 41.2; 46.7; 51.0; 52.1 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
57.5; 59.2; 69.1; 69.0; 75.0; 74.8 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
75.7; 79.1; 84.0; 88.1; 87.0; 87.0 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
90.2; 93.2; 92.7; 96.8; 94.9; 94.2 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
99.3; 98.9; 99.3; 98.9; 99.3; 98.9 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
98.5; 98.9; 98.5; 98.9; 98.5; 98.9 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
97.1; 98.6; 97.8; 98.6; 97.8; 98.9 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72 |
8.7; 8.6; 14.1; 15.5; 15.6; 20.2 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72 |
55.6; 62.3; 63.9; 70.3; 69.0; 69.2 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72 |
3.6; 1.5; 3.2; 1.9; 2.3; 1.5 | — |
| SECONDARY Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72 |
5.6; 5.9; 6.4; 6.3; 6.0; 7.8 | — |
| SECONDARY Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72 |
-287.3; -284.3; -302.9; -300.2; -307.8; -301.9 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72 |
88.8; 88.1; 94.5; 93.2; 96.4; 92.1 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72 |
46.1; 54.8; 53.8; 57.4; 65.3; 56.6 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72 |
76.1; 72.9; 93.1; 91.4; 96.4; 97.1 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72 |
37.8; 40.8; 50.9; 54.1; 63.8; 56.3 | — |
| SECONDARY Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72 |
-0.3; -0.1; 0.5; 0.0; 0.5; 0.6 | — |
| SECONDARY Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72 |
85.5; 84.1; 89.1; 87.7; 89.5; 88.4 | — |
| SECONDARY Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72 |
84.8; 82.3; 88.8; 85.9; 87.3; 87.0 | — |
| SECONDARY Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72 |
74.6; 73.6; 80.0; 77.2; 79.7; 79.0 | — |
| SECONDARY Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72 |
46.4; 51.3; 55.4; 54.2; 55.1; 52.7 | — |
| SECONDARY Part 2: Percentage of Participants on Different Treatment Intervals at Week 68 |
22.6; 25.0; 13.3; 18.0; 11.7; 9.4 | — |
| SECONDARY Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72 |
4.0; 4.0 | — |
| SECONDARY Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale |
45; 56; 76; 81; 40; 47 | — |
| SECONDARY Incidence of Ocular Adverse Events in the Fellow Eye |
25; 21; 37; 30; 0; 0 | — |
| SECONDARY Incidence of Non-Ocular Adverse Events |
94; 99; 136; 126; 9; 16 | — |
| SECONDARY Plasma Concentration of Faricimab Over Time |
0.0000; 0.0215; 0.0220; 0.0005; 0.0040; 0.0025 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study |
3; 4; 7; 33; 23; 56 | — |
Summary
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).
Eligibility Criteria
Inclusion Criteria
- Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit
- Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
- Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
Exclusion Criteria
- Any major illness or major surgical procedure within 1 month before screening
- Uncontrolled blood pressure
- Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
- Pregnant or breastfeeding, or intending to become pregnant during the study
Ocular Exclusion Criteria for Study Eye:
- History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
- Macular laser (focal/grid) in the study eye at any time prior to Day 1
- Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
- Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
- Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
- Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)
Ocular Exclusion Criteria for Both Eyes:
- Prior IVT administration of faricimab in either eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
Data sourced from ClinicalTrials.gov (NCT04740905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.