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

  • Eye Disorder
  • Macular Degeneration
  • Neoangiogenesis
  • Age‑Related Macular Degeneration
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • Abilene
  • Albuquerque
  • Arlington
  • Augusta
  • Austin
  • Bakersfield
  • Baltimore
  • Campbell
  • Carmel
  • Colorado Springs
  • Edina
  • Eugene
  • Germantown
  • Great Neck
  • Melbourne
  • Murray
  • Phoenix
  • Pompano Beach
  • Portland
  • Reno
  • St. Petersburg
  • Tallahassee
  • Tucson
  • West Des Moines
  • Willow Park
Trial Identifier:

NCT03038880 CR39521

  • California Retina Consultants

    5555 Business Park S93309BakersfieldUnited States
  • Charles Retina Institute

    1432 Kimbrough Rd38138GermantownUnited States
  • Eye Associates of New Mexico

    5757 Harper Dr NE87109AlbuquerqueUnited States
  • Florida Eye Associates

    509 E New Haven Ave32901MelbourneUnited States
  • Midwest Eye Institute

    10300 N Illinois St46290CarmelUnited States
  • Oregon Retina, LLP

    1125 Darlene Ln97401EugeneUnited States
  • Rand Eye

    5 W Sample Rd33064Pompano BeachUnited States
  • Retina Associates of Utah

    5169 S Cottonwood St84107MurrayUnited States
  • Retina Associates Southwest PC

    7470 N Oracle Rd85704TucsonUnited States
  • Retina Consultants of Southern Colorado PC; Clinical Research Department

    2770 N Union Blvd80909Colorado SpringsUnited States
  • Retina Northwest

    5440 SW Westgate Dr97221PortlandUnited States
  • Retina Res Institute of Texas

    5441 Health Center Dr79606AbileneUnited States
  • Retina Research Center

    9707 Anderson Mill Rd78750AustinUnited States
  • Retina Vitreous Assoc of FL

    4344 Central Ave33711St. PetersburgUnited States
  • Retinal Consultants of Arizona

    15401 N 29th Ave85053PhoenixUnited States
  • Retinal Diagnostic Center

    3395 S Bascom Ave95008CampbellUnited States
  • Sierra Eye Associates

    950 Ryland St89502RenoUnited States
  • Southeast Retina Center

    3685 Wheeler Rd30909AugustaUnited States
  • Southern Vitreoretinal Assoc

    2439 Care Dr32308TallahasseeUnited States
  • Strategic Clinical Research Group, LLC

    Willow ParkUnited States
  • Texas Retina Associates

    801 W Randol Mill Rd76012ArlingtonUnited States
  • The Retina Care Center

    6115 Falls Rd21209BaltimoreUnited States
  • Vitreo Retinal Surgery

    3601 W 76th St55435EdinaUnited States
  • Vitreoretinal Consultants

    600 Northern Blvd11021Great NeckUnited States
  • Wolfe Eye Clinic

    6200 Westown Pkwy50266West Des MoinesUnited States
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study 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.

    Hoffmann-La Roche Sponsor
    Phase 2 Phase
    NCT03038880, CR39521 Trial Identifier
    RO6867461, Ranibizumab, Faricimab, Sham Procedure Treatments
    Neovascularization, Choroidal, Macular Degeneration, Age-Related Condition
    Official Title

    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

    Eligibility Criteria

    All Gender
    ≥ 50 Years Age
    No Healthy Volunteers
    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 breastfeeding, or intended to become pregnant during the study
    • Known hypersensitivity to ranibizumab, fluorescein, any ingredients of the formulation used, dilating eye drops, or any of the anesthetic and antimicrobial drops used
    • Treatment with investigational therapy within 3 months before initiation of study treatment

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