Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration
STAIRWAY
STAIRWAY: Simultaneous Blockade of Angiopoietin-2 and VEGF-A With the Bispecific Antibody RO6867461 (RG7716) for Extended Durability in the Treatment of Neovascular Age-Related Macular Degeneration
1 other identifier
interventional
76
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2017
CompletedFirst Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2018
CompletedResults Posted
Study results publicly available
January 5, 2021
CompletedJanuary 5, 2021
December 1, 2020
12 months
January 31, 2017
December 9, 2020
December 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40, Using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA Charts
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline BCVA.
Baseline, Week 40
Secondary Outcomes (18)
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- +13 more secondary outcomes
Study Arms (3)
6 mg Faricimab Q12W
EXPERIMENTAL6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
6 mg Faricimab Q16W
EXPERIMENTAL6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
0.5 mg Ranibizumab Q4W
ACTIVE COMPARATOR0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Interventions
Faricimab was administered via IVT injections as specified during the treatment period.
Ranibizumab was administered via IVT injections as specified during the treatment period.
The sham was a procedure that mimicked an IVT injection and involved the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in the faricimab treatments arms at applicable visits to maintain masking among treatment arms.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Retinal Consultants of Arizona
Phoenix, Arizona, 85053, United States
Retina Associates Southwest PC
Tucson, Arizona, 85704, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
Retina Consultants of Southern Colorado PC; Clinical Research Department
Colorado Springs, Colorado, 80909-1183, United States
Rand Eye
Deerfield Beach, Florida, 33064, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Vitreo Retinal Surgery
Minneapolis, Minnesota, 55435, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Vitreoretinal Consultants
Great Neck, New York, 11021, United States
Oregon Retina, LLP
Eugene, Oregon, 97401, United States
Retina Northwest
Portland, Oregon, 97221, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Retina Res Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Retina Research Center
Austin, Texas, 78750, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
Related Publications (1)
Khanani AM, Patel SS, Ferrone PJ, Osborne A, Sahni J, Grzeschik S, Basu K, Ehrlich JS, Haskova Z, Dugel PU. Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):964-972. doi: 10.1001/jamaophthalmol.2020.2699.
PMID: 32729897DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Interpretability of the imaging endpoints is limited by the relatively small sample size of the study and imbalances between the arms at baseline. Formal comparisons could not be performed across the treatment arms.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 1, 2017
Study Start
January 27, 2017
Primary Completion
January 11, 2018
Study Completion
March 29, 2018
Last Updated
January 5, 2021
Results First Posted
January 5, 2021
Record last verified: 2020-12