Phase 3
N=671
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)
Wet Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT03823287 ↗Enrolled (actual)
671
Serious AEs
25.9%
Results posted
May 2022
Primary outcome: Primary: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 — 5.8; 5.1 ETDRS Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Faricimab (Drug); Aflibercept (Drug); Sham Procedure (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 |
5.8; 5.1 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 |
5.4; 4.6 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye Over Time |
4.0; 3.6; 5.5; 4.5; 6.4; 5.3 | — |
| SECONDARY Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 |
20.0; 15.7; 37.1; 31.7; 59.2; 58.0 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 |
19.2; 16.6 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time |
10.1; 6.3; 13.7; 8.1; 16.7; 10.1 | — |
| SECONDARY Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time |
20.1; 16.0; 28.6; 25.3; 31.4; 30.3 | — |
| SECONDARY Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time |
47.6; 45.6; 57.8; 52.3; 61.5; 55.0 | — |
| SECONDARY Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time |
78.9; 77.6; 80.7; 78.3; 84.2; 81.4 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 |
95.4; 94.1; 91.6; 92.0; 88.0; 86.8 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 |
93.9; 94.1 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time |
97.6; 99.0; 97.6; 98.7; 98.2; 97.5 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time |
95.1; 96.2; 96.0; 96.9; 96.3; 95.5 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time |
90.5; 90.6; 92.3; 90.6; 92.2; 88.8 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 |
24.3; 21.3 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time |
11.0; 8.1; 16.3; 11.1; 20.4; 14.9 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 |
56.4; 57.0 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time |
52.8; 50.5; 54.5; 50.7; 58.3; 53.4 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 |
6.4; 6.9 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time |
5.5; 5.5; 5.8; 5.9; 4.6; 5.6 | — |
| SECONDARY Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48 |
20.3; 34.0; 45.7 | — |
| SECONDARY Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60 |
20.2; 33.4; 46.4 | — |
| SECONDARY Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112 |
25.8; 15.1; 59.0 | — |
| SECONDARY Number of Study Drug Injections Received in the Study Eye Through Week 48 |
6.0; 8.0 | — |
| SECONDARY Number of Study Drug Injections Received in the Study Eye Through Week 60 |
7.0; 9.0 | — |
| SECONDARY Number of Study Drug Injections Received in the Study Eye Through Week 108 |
10.0; 15.0 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48 |
-136.8; -129.4 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60 |
-134.5; -135.5 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Over Time |
-131.7; -116.3; -142.6; -131.8; -149.0; -136.1 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time |
89.2; 85.2; 87.5; 84.3; 89.3; 85.4 | — |
| SECONDARY Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time |
67.8; 58.8; 84.5; 76.4; 87.2; 78.5 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time |
60.8; 49.0; 74.5; 63.1; 77.4; 66.3 | — |
| SECONDARY Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time |
5.3; 4.9; 3.5; 4.3; 2.9; 2.1 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time |
— | — |
| SECONDARY Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48 |
0.0; 0.4 | — |
| SECONDARY Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112 |
1.2; 1.6 | — |
| SECONDARY Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48 |
-3.8; -3.0 | — |
| SECONDARY Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112 |
-5.4; -5.0 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event |
88.3; 89.3; 24.0; 27.7; 3.6; 2.7 | — |
| SECONDARY Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye |
55.0; 56.5; 4.2; 3.9; 1.8; 0.6 | — |
| SECONDARY Percentage of Participants With at Least One Non-Ocular Adverse Event |
75.7; 72.9; 19.8; 22.6; 1.8; 2.1 | — |
| SECONDARY Plasma Concentration of Faricimab Over Time |
0.0000; 0.0288; 0.0337; 0.0044; 0.0139; 0.0057 | — |
| SECONDARY Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study |
11.5; 11.2; 0.3 | — |
Summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
- Ability to comply with the study protocol, in the investigator's judgment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate 180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
- Pregnancy or breastfeeding, or intention to become pregnant during the study
- CNV due to causes other than AMD in the study eye
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
- Uncontrolled glaucoma in the study eye
- Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
- Prior IVT administration of faricimab in either eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Active ocular inflammation or suspected or active ocular or periocular infection in either eye
- Other protocol-specified exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03823287). 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.