NCT03038880

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neovascularization, Choroidal
• Macular Degeneration, Age-Related

Interventions

Type	Name	Description
DRUG	Faricimab	Faricimab was administered via IVT injections as specified during the treatment period.
DRUG	Ranibizumab	Ranibizumab was administered via IVT injections as specified during the treatment period.
DRUG	Sham Procedure	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.

Timeline

• Start date: 2017-01-27
• Primary completion: 2018-01-11
• Completion: 2018-03-29
• First posted: 2017-02-01
• Last updated: 2021-01-05
• Results posted: 2021-01-05

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study