At a glance
ClinicalIndex Comparison Record- ✓Treatment-naive CNV secondary to AMD (age-related macular degeneration)
- ✓Subfoveal or juxtafoveal CNV with subfoveal component, confirmed by fundus fluorescence angiography (FFA) or spectral-domain optical coherence tomography (SD-OCT)
- ✓CNV lesion with total lesion size ≤6 disc areas, CNV component ≥50% of total lesion, active CNV confirmed by FFA leakage, and exudation confirmed by SD-OCT (fluid present)
- ✓Best-corrected visual acuity (BCVA) of 24–73 ETDRS letters (Snellen equivalent 20/320–20/40)
- ✕CNV due to causes other than AMD (e.g., ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis)
- ✕Any prior or concomitant treatment for CNV, including intravitreous injections (steroids, anti-VEGF, tPA, ocriplasmin, C3F8 gas), periocular treatment, argon laser, photodynamic therapy, or surgical intervention
- ✕Subretinal hemorrhage, fibrosis, or atrophy involving >50% of total lesion area and/or fovea on FFA
- ✕Cataract surgery within 3 months of baseline or any other intraocular surgery (vitrectomy, glaucoma surgery, corneal transplant)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Faricimab, Ranibizumab, and 1 other intervention for Neovascularization, Choroidal and Macular Degeneration, Age-Related. Completed, enrolled 76 participants across 25 sites.
Detailed 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.
Study Details
Timeline
Interventions
Faricimab was administered via IVT injections as specified during the treatment period.
Ranibizumab was administered via IVT injections as specified during the treatment period.
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.