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

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ClinicalTrials.gov Identifier: NCT03038880
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE February 1, 2017
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE January 27, 2017
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40 Using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Like Charts [ Time Frame: Baseline, Week 40 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03038880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Change From Baseline in BCVA at Protocol Specified Time-Points Using the ETDRS-Like Charts [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants Gaining Greater Than or Equal to (>/=) 15, >/=10, >/=5, or >/=0 Letters From Baseline in BCVA at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants Avoiding Loss of >/=15, >/=10, >/=5, or >/=0 Letters From Baseline in BCVA at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants With BCVA of 20/40 or Better [ Time Frame: Baseline up to Week 52 ]
  • Percentage of Participants With BCVA of 20/200 or Worse [ Time Frame: Baseline up to Week 52 ]
  • Change From Baseline in Central Foveal Thickness (CFT) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Change From Baseline in Central Subfield Thickness (CST) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants With Intraretinal Fluid, Subretinal Fluid, Cysts, or Pigment Epithelial Detachment [ Time Frame: Baseline, up to Week 52 ]
  • Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Change From Baseline in Total Area of CNV Component at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Change From Baseline in Total Area of Leakage at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants With Anti-Faricimab Antibodies [ Time Frame: Baseline up to Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Change From Baseline in BCVA at Protocol Specified Time-Points Using the ETDRS-Like Charts [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants Gaining Greater Than or Equal to (>/=) 15, >/=10, >/=5, or >/=0 Letters From Baseline in BCVA at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants Avoiding Loss of >/=15, >/=10, >/=5, or >/=0 Letters From Baseline in BCVA at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants With BCVA of 20/40 or Better [ Time Frame: Baseline up to Week 52 ]
  • Percentage of Participants With BCVA of 20/200 or Worse [ Time Frame: Baseline up to Week 52 ]
  • Change From Baseline in Central Foveal Thickness (CFT) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Change From Baseline in Central Subfield Thickness (CST) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants With Intraretinal Fluid, Subretinal Fluid, Cysts, or Pigment Epithelial Detachment [ Time Frame: Baseline, up to Week 52 ]
  • Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Change From Baseline in Total Area of CNV Component at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Change From Baseline in Total Area of Leakage at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  • Percentage of Participants With Anti-RO6867461 Antibodies [ Time Frame: Baseline up to Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration (nAMD)
Official Title  ICMJE 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
Brief Summary This is 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 nAMD. Only one eye will be chosen as the study eye.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neovascularization, Choroidal
  • Macular Degeneration, Age-Related
Intervention  ICMJE
  • Drug: Faricimab
    Faricimab will be administered via IVT injections as specified during the treatment period.
    Other Name: RO6867461; RG7716
  • Drug: Ranibizumab
    Ranibizumab will be administered via IVT injections as specified during the treatment period.
Study Arms  ICMJE
  • Experimental: Faricimab (Short interval)
    Faricimab will be given via intravitreal (IVT) administration at a short interval duration during the 52 weeks treatment period.
    Intervention: Drug: Faricimab
  • Experimental: Faricimab (Long interval)
    Faricimab will be given via IVT administration at a long interval duration during the 52 weeks treatment period.
    Intervention: Drug: Faricimab
  • Sham Comparator: Ranibizumab
    Ranibizumab will be given via IVT administration during the 52 weeks treatment period.
    Intervention: Drug: Ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2017)
76
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
75
Actual Study Completion Date  ICMJE March 29, 2018
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Treatment-naive CNV secondary to AMD
  • Subfoveal or juxtafoveal CNV with a subfoveal component related to the CNV activity
  • Active CNV
  • BCVA letter score of 73 to 24 letters (inclusive)

Exclusion Criteria:

  • CNV due to causes other than AMD
  • Retinal pigment epithelial tear involving the macula
  • On fundus fluorescein angiography (FFA) subretinal hemorrhage, fibrosis or atrophy of >50% of the total lesion area and/or that involves the fovea
  • Cataract surgery within 3 months of baseline assessments
  • Uncontrolled blood pressure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03038880
Other Study ID Numbers  ICMJE CR39521
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP