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

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

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

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

Original Estimated Enrollment ^ICMJE

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

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

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