Phase 2 N=263 Randomized Double-blind Treatment

A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Choroidal Neovascularization

Bottom Line

View on ClinicalTrials.gov: NCT02484690 ↗

Enrolled (actual)

263

Serious AEs

15.3%

Results posted

Oct 2020

Primary outcome: Primary: Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants — 7.61; 9.18; 6.02; 6.10 BCVA Letters — p=0.5244

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Faricimab (Drug); Ranibizumab (Drug); Sham Procedure (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants	7.61; 9.18; 6.02; 6.10	0.5244
PRIMARY Mean Change From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders	1.72; 0.04	0.3034
SECONDARY Percentage of Participants Gaining Greater Than or Equal to (≥) 15 Letters From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants	31.0; 36.6; 27.9; 23.7	0.5527
SECONDARY Percentage of Participants Gaining ≥15 Letters From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders	5.71; 0.00	0.2328
SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Treatment-Naive Participants	49.5; 49.0; 39.4; 41.8	0.9581
SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Anti-VEGF Incomplete Responders	22.86; 16.22	0.5586
SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Treatment-Naive Participants	7.7; 8.7; 15.8; 8.8	0.8536
SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Anti-VEGF Incomplete Responders	14.29; 13.51	1.0000
SECONDARY Mean Change From Baseline in Foveal Center Point Thickness at Week 36, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT), in Treatment-Naive Participants	-194.00; -181.35; -193.12; -161.20	0.3798
SECONDARY Mean Change From Week 12 in Foveal Center Point Thickness at Week 36, as Measured by SD-OCT, in Anti-VEGF Incomplete Responders	-14.5; -20.8	0.5185
SECONDARY Mean Change From Baseline in Central Subfield Thickness at Week 36, as Measured by SD-OCT, in Treatment-Naive Participants	-176.18; -156.73; -173.40; -147.66	0.1624
SECONDARY Mean Change From Week 12 in Central Subfield Thickness at Week 36, as Measured by SD-OCT in Anti-VEGF Incomplete Responders	-17.00; -31.42	0.2089
SECONDARY Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants	52; 29; 29; 38; 13; 7	—
SECONDARY Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders	9; 11; 4; 5; 5; 6	—
SECONDARY Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by Fundus Fluorescein Angiography (FFA), in Treatment-Naive Participants	-3.41; -3.81; -3.19; -3.31	0.6717
SECONDARY Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders	-0.50; -1.37	—
SECONDARY Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Treatment-Naive Participants	-4.18; -5.14; -2.96; -3.83	0.3189
SECONDARY Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders	-1.87; -1.88	—
SECONDARY Mean Change From Baseline in Total Area of Leakage at Week 36, as Measured by FFA, in Treatment-Naive Participants	-5.15; -5.94; -3.71; -4.66	0.4353
SECONDARY Mean Change From Week 12 in Total Area of Leakage at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders	-1.87; -2.00	—
SECONDARY Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants	51; 39; 31; 39; 54; 39	—
SECONDARY Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants	28; 21; 21; 27; 28; 27	—
SECONDARY Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants	37; 37; 23; 30; 43; 30	—
SECONDARY Number of Participants With Abnormal Systolic Blood Pressure, in All Participants	0; 0; 0; 0; 0; 20	—
SECONDARY Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants	0; 0; 0; 0; 0; 15	—
SECONDARY Number of Participants With Abnormal Heart Rate, in All Participants	1; 0; 1; 0; 0; 1	—
SECONDARY Number of Participants With Abnormal Body Temperature, in All Participants	28; 19; 14; 25; 29; 4	—
SECONDARY Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants	1; 0; 0; 0; 0; 1	—
SECONDARY Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants	0; 0; 1; 0; 0; 0	—
SECONDARY Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants	15.07; 14.74; 14.69; 14.98; 14.27; 1.90	—
SECONDARY Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint	1; 0; 0; 0; 41; 35	—
SECONDARY Mean Plasma Concentration of Faricimab Over Time, in All Participants	0.40; 0.40; 0.40; 0.47; 8.83; 31.06	—
SECONDARY Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants	15.25; 16.83; 24.63; 16.53; 22.60; 0.52	—
SECONDARY Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants	2.14; 1.81; 1.86; 1.80; 1.92; 0.03	—
SECONDARY Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants	2.19; 1.81; 1.88; 1.73; 1.95; 0.00	—

Summary

This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study was designed to allow the evaluation of RO6867461 in a treatment-naive population (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per participant was chosen as the study eye.

Eligibility Criteria

Inclusion Criteria

Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity by FFA or SD-OCT
Active CNV

Exclusion Criteria

CNV due to causes other than AMD
Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area
Cataract surgery within 3 months of baseline, or any other previous intraocular surgery
Major illness or surgery within 1 month prior to Screening
Glycosylated hemoglobin (HbA1c) above 7.5%
Uncontrolled blood pressure

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02484690). 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.