Phase 3
N=729
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Macular Edema · Central Retinal Vein Occlusion · Hemiretinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT04740931 ↗Enrolled (actual)
729
Serious AEs
12.0%
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; 17.3 ETDRS Letters — p=0.6715
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
- Aug 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; 17.3 | 0.6715 |
| SECONDARY Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 |
13.5; 14.3; 15.5; 16.5; 16.9; 17.1 | — |
| SECONDARY Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24 |
56.6; 58.1 | — |
| SECONDARY Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
41.5; 45.4; 51.1; 53.7; 54.6; 55.1 | — |
| SECONDARY Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
60.9; 62.3; 69.1; 72.8; 73.2; 74.7 | — |
| SECONDARY Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
83.1; 83.5; 85.2; 86.8; 87.4; 87.1 | — |
| SECONDARY Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
92.1; 95.6; 92.1; 94.8; 93.2; 92.6 | — |
| 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 |
98.4; 98.9; 98.1; 98.1; 98.6; 97.5 | — |
| 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 |
98.1; 98.6; 97.5; 97.5; 97.8; 97.0 | — |
| 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 |
97.0; 98.1; 96.2; 96.4; 95.9; 96.1 | — |
| 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 |
6.0; 4.7; 8.7; 10.2; 10.9; 11.9 | — |
| 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 |
45.0; 46.1; 48.6; 54.6; 54.9; 55.7 | — |
| 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 |
10.0; 8.6; 8.2; 7.0; 7.3; 6.4 | — |
| SECONDARY Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24 |
-420.8; -417.3; -444.2; -437.5; -451.0; -442.5 | — |
| SECONDARY Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24 |
83.8; 82.4; 92.6; 91.2; 93.4; 91.5 | — |
| SECONDARY Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
45.5; 40.3; 63.1; 61.7; 53.2; 51.0 | — |
| SECONDARY Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
66.1; 65.0; 89.6; 90.1; 94.0; 93.9 | — |
| SECONDARY Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
33.0; 29.3; 59.3; 59.3; 52.7; 50.2 | — |
| SECONDARY Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24 |
6.9; 8.1 | — |
| SECONDARY Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72 |
13.6; 14.3; 15.6; 16.5; 17.0; 17.2 | — |
| 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 |
41.5; 45.2; 51.1; 53.7; 54.6; 55.1 | — |
| 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 |
60.9; 62.3; 69.1; 72.8; 73.2; 74.7 | — |
| 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 |
83.1; 83.5; 85.2; 86.8; 87.4; 87.1 | — |
| 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 |
92.1; 95.6; 92.1; 94.8; 93.2; 92.6 | — |
| 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 |
98.4; 98.9; 98.1; 98.1; 98.6; 97.5 | — |
| 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 |
98.1; 98.6; 97.5; 97.5; 97.8; 97.0 | — |
| 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 |
97.0; 98.1; 96.2; 96.4; 95.9; 96.1 | — |
| 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 |
6.0; 4.7; 8.7; 10.2; 10.9; 11.9 | — |
| 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 |
45.0; 46.1; 48.6; 54.6; 54.9; 55.7 | — |
| 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 |
10.0; 8.6; 8.2; 7.0; 7.3; 6.4 | — |
| SECONDARY Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72 |
7.0; 8.2; 7.0; 8.3; 7.8; 8.5 | — |
| SECONDARY Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72 |
-422.1; -418.2; -445.1; -438.5; -452.3; -443.7 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72 |
83.8; 82.4; 92.6; 91.2; 93.4; 91.5 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72 |
45.5; 40.6; 63.1; 61.7; 53.2; 51.0 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72 |
66.1; 65.0; 89.6; 90.1; 94.0; 93.9 | — |
| 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 |
33.0; 29.3; 59.3; 59.3; 52.7; 50.2 | — |
| SECONDARY Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72 |
-0.8; -1.2; 0.2; 0.2; -0.1; 0.1 | — |
| 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 |
86.3; 83.8; 88.8; 87.9; 89.3; 87.9 | — |
| 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 |
82.8; 81.3; 87.1; 86.0; 84.7; 85.4 | — |
| 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 |
72.7; 69.7; 78.4; 75.5; 74.1; 80.2 | — |
| 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 |
48.9; 45.4; 56.0; 52.9; 55.5; 55.1 | — |
| SECONDARY Part 2: Percentage of Participants on Different Treatment Intervals at Week 68 |
34.5; 32.4; 20.0; 17.5; 8.5; 11.1 | — |
| SECONDARY Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72 |
5.0; 4.0 | — |
| SECONDARY Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale |
89; 98; 130; 118; 65; 65 | — |
| SECONDARY Incidence of Ocular Adverse Events in the Fellow Eye |
31; 33; 70; 51; 1; 1 | — |
| SECONDARY Incidence of Non-Ocular Adverse Events |
123; 134; 191; 174; 22; 23 | — |
| SECONDARY Plasma Concentration of Faricimab Over Time |
0.0001; 0.0222; 0.0257; 0.0005; 0.0055; 0.0026 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study |
4; 5; 9; 62; 27; 89 | — |
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 patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
Eligibility Criteria
Inclusion Criteria
- Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), 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)
- 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 sheathotomy
- 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 (NCT04740931). 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.