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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

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.

Condition or disease Intervention/treatment Phase
Neovascularization, Choroidal Macular Degeneration, Age-Related Drug: Faricimab Drug: Ranibizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 27, 2017
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : March 29, 2018


Arm Intervention/treatment
Experimental: Faricimab (Short interval)
Faricimab will be given via intravitreal (IVT) administration at a short interval duration during the 52 weeks treatment period.
Drug: Faricimab
Faricimab will be administered via IVT injections as specified during the treatment period.
Other Name: RO6867461; RG7716

Experimental: Faricimab (Long interval)
Faricimab will be given via IVT administration at a long interval duration during the 52 weeks treatment period.
Drug: Faricimab
Faricimab will be administered via IVT injections as specified during the treatment period.
Other Name: RO6867461; RG7716

Sham Comparator: Ranibizumab
Ranibizumab will be given via IVT administration during the 52 weeks treatment period.
Drug: Ranibizumab
Ranibizumab will be administered via IVT injections as specified during the treatment period.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change From Baseline in BCVA at Protocol Specified Time-Points Using the ETDRS-Like Charts [ Time Frame: Baseline, up to Week 52 ]
  2. 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 ]
  3. 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 ]
  4. Percentage of Participants With BCVA of 20/40 or Better [ Time Frame: Baseline up to Week 52 ]
  5. Percentage of Participants With BCVA of 20/200 or Worse [ Time Frame: Baseline up to Week 52 ]
  6. Change From Baseline in Central Foveal Thickness (CFT) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  7. Change From Baseline in Central Subfield Thickness (CST) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  8. Percentage of Participants With Intraretinal Fluid, Subretinal Fluid, Cysts, or Pigment Epithelial Detachment [ Time Frame: Baseline, up to Week 52 ]
  9. Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  10. Change From Baseline in Total Area of CNV Component at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  11. Change From Baseline in Total Area of Leakage at Protocol Specified Time-Points [ Time Frame: Baseline, up to Week 52 ]
  12. Percentage of Participants With Anti-Faricimab Antibodies [ Time Frame: Baseline up to Week 52 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038880


  Hide Study Locations
Locations
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United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85012
Retina Associates Southwest PC
Tucson, Arizona, United States, 85750
United States, California
California Retina Consultants
Bakersfield, California, United States, 93309
Retinal Diagnostic Center
Campbell, California, United States, 95008
United States, Colorado
Retina Consultants of Southern Colorado PC; Clinical Research Department
Colorado Springs, Colorado, United States, 80909-1183
Colorado Retina Associates, PC
Golden, Colorado, United States, 80201
United States, Florida
Rand Eye
Deerfield Beach, Florida, United States, 33064
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Florida Eye Associates
Melbourne, Florida, United States, 32901
Retina Vitreous Assoc of FL
Saint Petersburg, Florida, United States, 33711
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States, 32308
United States, Georgia
Southeast Retina Center
Augusta, Georgia, United States, 30909
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Iowa
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
United States, Maryland
The Retina Care Center
Baltimore, Maryland, United States, 21209
United States, Minnesota
Vitreo Retinal Surgery
Minneapolis, Minnesota, United States, 55435
United States, Nevada
Sierra Eye Associates
Reno, Nevada, United States, 89502
United States, New Jersey
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey, United States, 08034
United States, New Mexico
Eye Associates of New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
Vitreoretinal Consultants
Great Neck, New York, United States, 11021
Opthalmic Consultants of LI
Lynbrook, New York, United States, 11563
United States, North Carolina
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States, 28210
United States, Ohio
Retina Assoc of Cleveland Inc
Cleveland, Ohio, United States, 44122
United States, Oregon
Oregon Retina, LLP
Eugene, Oregon, United States, 97401
Retina Northwest
Portland, Oregon, United States, 97221
United States, Tennessee
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, United States, 37421
Charles Retina Institution
Germantown, Tennessee, United States, 38138
United States, Texas
Retina Res Institute of Texas
Abilene, Texas, United States, 79606
Texas Retina Associates
Arlington, Texas, United States, 76012
Austin Retina Associates
Austin, Texas, United States, 78705
Retina Research Center
Austin, Texas, United States, 78705
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States, 76087
United States, Utah
Retina Associates of Utah
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03038880     History of Changes
Other Study ID Numbers: CR39521
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Macular Degeneration
Neovascularization, Pathologic
Wet Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents