Phase 2
Completed N=227
A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
Source: ClinicalTrials.gov NCT02699450 ↗Enrolled (actual)
227
Serious AEs
10.7%
Results posted
Sep 2020
Primary outcomePrimary: Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants — 10.3; 11.7; 13.9 BCVA letters — p=0.37
Summary
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants |
10.3; 11.7; 13.9 | 0.37 |
| SECONDARY Mean Change From Baseline in BCVA Letter Score at Week 24, in Previously Treated Participants |
8.9; 9.6 | 0.63 |
| SECONDARY Mean Change From Baseline in BCVA Letter Score at Week 24, in All Participants |
9.4; 11.7; 12.3 | 0.15 |
| SECONDARY Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Treatment-Naive Participants |
35.3; 36.0; 42.5 | 0.94 |
| SECONDARY Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Previously Treated Participants |
16.8; 23.2 | 0.56 |
| SECONDARY Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in All Participants |
28.7; 35.3; 35.9 | 0.43 |
| SECONDARY Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Treatment-Naive Participants |
69.0; 78.5; 75.8 | 0.27 |
| SECONDARY Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Previously Treated Participants |
69.0; 68.4 | 0.96 |
| SECONDARY Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in All Participants |
69.0; 78.9; 73.2 | 0.19 |
| SECONDARY Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Treatment-Naive Participants |
11.5; 8.7; 9.8 | 0.64 |
| SECONDARY Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Previously Treated Participants |
10.5; 8.2 | 0.78 |
| SECONDARY Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in All Participants |
11.1; 10.6; 9.1 | 0.93 |
| SECONDARY Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Treatment-Naive Participants |
-243.4; -249.9; -266.2 | 0.69 |
| SECONDARY Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Previously Treated Participants |
-162.1; -211.3 | 0.07 |
| SECONDARY Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in All Participants |
-210.7; -228.0; -239.9 | 0.28 |
| SECONDARY Mean Change From Baseline in Central Subfield Thickness at Week 24, in Treatment-Naive Participants |
-204.7; -217.1; -225.8 | 0.36 |
| SECONDARY Mean Change From Baseline in Central Subfield Thickness at Week 24, in Previously Treated Participants |
-148.0; -186.6 | 0.07 |
| SECONDARY Mean Change From Baseline in Central Subfield Thickness at Week 24, in All Participants |
-180.2; -200.3; -206.9 | 0.12 |
| SECONDARY Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants |
4.08; 0.00; 0.00 | 0.4948 |
| SECONDARY Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants |
7.14; 4.35 | 1.0000 |
| SECONDARY Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants |
87.76; 81.63; 90.91 | 0.5759 |
| SECONDARY Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants |
89.29; 91.30 | 1.0000 |
| SECONDARY Number of Participants With Presence or Absence of Leakage at the Macula at Week 24, in Treatment-Naive Participants |
41; 41; 25; 4; 5; 11 | — |
| SECONDARY Number of Participants With Presence or Absence of Leakage at the Macula at Week 24, in Previously Treated Participants |
24; 1; 14; 1; 0; 2 | — |
| SECONDARY Mean Change From Baseline in the Size of the Foveal Avascular Zone at Week 24, in All Participants |
— | — |
| SECONDARY Mean Plasma Concentrations of Ranibizumab (Arm A) or Faricimab (Arms B and C) Over Time, in All Participants |
2.20; 0.40; 0.40; 2.52; 48.36; 172.24 | — |
| SECONDARY Baseline and Change From Baseline in Free Vascular Endothelial Growth Factor (VEGF) Plasma Levels Over Time, in Treatment-Naive Participants |
23.93; 14.93; 12.45; -9.44; -3.85; -3.61 | — |
| SECONDARY Baseline and Change From Baseline in Free Vascular Endothelial Growth Factor (VEGF) Plasma Levels Over Time, in Previously Treated Participants |
12.94; 7.80; 16.21; 0.50; 8.20; -7.40 | — |
| SECONDARY Baseline and Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Treatment-Naive Participants |
2.77; 2.07; 2.30; 0.07; 0.04; 0.75 | — |
| SECONDARY Baseline and Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Treatment-Naive Participants |
3.05; 2.38; 2.46; -0.49; -0.59; 0.06 | — |
| SECONDARY Baseline and Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Previously Treated Participants |
2.40; 1.84; 2.31; 0.15; 0.11; 0.94 | — |
| SECONDARY Baseline and Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Previously Treated Participants |
2.67; 2.08; 2.35; -0.07; -0.04; 0.30 | — |
| SECONDARY Safety Summary of the Number of Participants With at Least One Adverse Event During the Treatment Period (up to Week 24), in All Participants |
61; 38; 54; 30; 21; 32 | — |
| SECONDARY Safety Summary of the Number of Participants With at Least One Adverse Event During the Post-Treatment Observation Period, in All Participants |
31; 21; 34; 11; 7; 12 | — |
| SECONDARY Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye During the Treatment Period by Highest Intensity, in All Participants |
22; 16; 22; 20; 15; 21 | — |
| SECONDARY Number of Participants With at Least One Systemic Adverse Event During the Treatment Period by Highest Intensity, in All Participants |
51; 30; 46; 34; 19; 34 | — |
| SECONDARY Number of Participants With Abnormal Systolic Blood Pressure Over Time, in All Participants |
0; 0; 0; 1; 3; 0 | — |
| SECONDARY Number of Participants With Abnormal Diastolic Blood Pressure Over Time, in All Participants |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With an Abnormal Heart Rate Over Time, in All Participants |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Abnormal Body Temperature Over Time, in All Participants |
8; 4; 7; 0; 0; 1 | — |
| SECONDARY Mean Heart Rate at Baseline and Week 24, as Measured by Electrocardiogram in All Participants |
71.52; 73.65; 74.12; 71.12; 73.96; 75.61 | — |
| SECONDARY Mean PR, RR, QT, QRS, QTcB, and QTcF Intervals at Baseline and Week 24, as Measured by Electrocardiogram in All Participants |
172.57; 168.50; 170.91; 171.95; 167.49; 172.02 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Hematology Tests, in All Participants |
2; 1; 3; 1; 1; 3 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Coagulation Tests, in All Participants |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Tested Negative or Positive for Anti-Drug Antibodies Against Faricimab Over Time |
53; 75; 1; 2; 50; 67 | — |
Eligibility Criteria
Inclusion Criteria
- Macular edema associated with diabetic retinopathy
- Decreased visual acuity attributable primarily to DME
- Diagnosis of diabetes mellitus
Exclusion Criteria
- High risk proliferative diabetic retinopathy
- Cataract surgery within 3 months of Baseline, or any other previous intraocular surgery
- Uncontrolled glaucoma
- Current or history of ocular disease in the study eye other than DME
- Major illness or major surgical procedure within 1 month prior to Day 1
- Uncontrolled blood pressure
- Glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%) at screening
- Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1
Data sourced from ClinicalTrials.gov (NCT02699450). 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. Informational only — not medical advice.