Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration (nAMD)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 1/17/2019 |
| Start Date: | January 27, 2017 |
| End Date: | March 29, 2018 |
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
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.
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.
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
We found this trial at
33
sites
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
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