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Phase 2 Completed N=71 Randomized Double-blind Treatment

Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration

Neovascularization, Choroidal · Macular Degeneration, Age-Related
Source: ClinicalTrials.gov NCT03038880 ↗
Enrolled (actual)
71
Serious AEs
9.9%
Results posted
Jan 2021
Primary outcomePrimary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40, Using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA Charts — 9.3; 12.5; 11.4 ETDRS Letters

Summary

This was a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to investigate the efficacy, safety and pharmacokinetics of faricimab (RO6867461; RG7716) administered with extended dosing regimens in treatment-naive participants with neovascular age related macular degeneration (nAMD). Only one eye was chosen as the study eye.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40, Using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA Charts
9.3; 12.5; 11.4
SECONDARY
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
3.78; 4.62; 3.53; 5.99; 7.55; 7.53
SECONDARY
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
1; 2; 1; 2; 4; 1
SECONDARY
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
4.2; 6.5; 6.3; 12.5; 12.9; 18.8
SECONDARY
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
24; 31; 16; 24; 31; 16
SECONDARY
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
100.0; 100.0; 100.0; 100.0; 100.0; 100.0
SECONDARY
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
12.5; 22.6; 18.8; 20.8; 45.2; 18.8
SECONDARY
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
8.3; 3.2; 12.5; 4.2; 0; 0
SECONDARY
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
-93.56; -94.31; -76.01; -132.27; -130.11; -122.07
SECONDARY
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
-88.87; -84.23; -80.08; -127.20; -123.10; -111.58
SECONDARY
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
4.2; 29.0; 18.8; 21.7; 38.7; 25.0
SECONDARY
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
20.8; 12.9; 25.0; 39.1; 29.0; 31.3
SECONDARY
Percentage of Participants With No Cysts at Specified Timepoints
33.3; 48.4; 37.5; 65.2; 83.9; 75.0
SECONDARY
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
8.3; 29.0; 12.5; 13.0; 29.0; 12.5
SECONDARY
Mean Baseline Value and Mean Change From Baseline of Total Area of Choroidal Neovascularization (CNV) at Week 40 and Week 52
7.1; 5.9; 7.3; -4.7; -3.9; -4.6
SECONDARY
Mean Baseline Value and Mean Change From Baseline of Total Area of CNV Component at Week 40 and Week 52
7.0; 5.8; 7.1; -5.0; -4.0; -4.7
SECONDARY
Mean Baseline Value and Mean Change From Baseline of Total Area of Leakage at Week 40 and Week 52
7.0; 6.1; 7.6; -5.0; -4.3; -5.3
SECONDARY
Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
21; 25; 1; 4; 0; 1
SECONDARY
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
18; 23; 13; 4; 3; 0

Eligibility Criteria

Inclusion Criteria

  • Treatment-naive CNV secondary to AMD (nAMD)
  • Subfoveal or juxtafoveal CNV with a subfoveal component related to the CNV activity by fundus fluorescein angiography (FFA) or spectral-domain optical coherence tomography (SD-OCT; as evidenced by subretinal fluid, subretinal hyperreflective material, evidence of leakage, or hemorrhage)
  • CNV lesion of all types with: total lesion size (including blood, atrophy, fibrosis, and neovascularization) of 6 disc areas or less by FFA; and CNV component area of at least 50% of total lesion size by FFA; and active CNV confirmed by FFA (evidence of leakage); and CNV exudation confirmed by SD-OCT (presence of fluid)
  • BCVA letter score of 73 to 24 letters (inclusive) on ETDRS-like charts (20/40-20/320 Snellen equivalent) on day 1
  • Clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis

Exclusion Criteria

  • CNV due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
  • Central serous chorioretinopathy at screening
  • Retinal pigment epithelial tear involving the macula
  • On FFA: subretinal hemorrhage, fibrosis, or atrophy of more than (>)50% of the total lesion area and/or that involves the fovea
  • Any prior or concomitant treatment for CNV including (but not restricted to) IVT treatment (steroids, anti-VEGF, tissue plasminogen activator, ocriplasmin, C3F8 gas, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or surgical intervention
  • Cataract surgery within 3 months of baseline assessments
  • Any other intraocular surgery (pars plana vitrectomy, glaucoma surgery, corneal transplant, radiotherapy)
  • Prior IVT treatment (including anti-VEGF medication) except for management of cataract complication with steroid IVT treatment
  • Prior periocular pharmacological intervention for other retinal diseases
  • Any concurrent intraocular condition in the study eye (eg, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the course of the study
  • Active intraocular inflammation (grade trace or above) in the study eye on day 1 (before randomization)
  • Current vitreous hemorrhage in the study eye
  • Uncontrolled glaucoma (eg, progressive loss of visual fields or defined as IOP ≥25 mm Hg despite treatment with antiglaucoma medication) in the study eye
  • Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye on day 1 (before randomization)
  • Any major illness or major surgical procedure within 1 month before screening
  • Uncontrolled blood pressure (defined as systolic >180 mm Hg and/or diastolic >100 mm Hg while participant at rest). If a participant's initial reading exceeded these values, a second reading was taken later on the same day, or on another day during the screening period. If the participant's blood pressure was controlled by antihypertensive medication, the participant was taking the same medication continuously for at least 30 days before day 1
  • Stroke or myocardial infarction within 3 months before day 1
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
  • Pregnant or breas
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03038880). 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.

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