A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
Summary
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.
Timeline
- Start
- 2016-04-27
- Primary completion
- 2017-09-15
- Completion
- 2017-12-14
Outcome
Met primary endpoint
paper The 6.0-mg faricimab dose demonstrated a statistically significant gain of 3.6 letters over ranibizumab (P = 0.03). PMID 30905643 ↗
paper The BOULEVARD trial met its primary end point; faricimab demonstrated statistically superior visual acuity gains versus ranibizumab at week 24 in treatment-naïve patients. PMID 30905643 ↗
Publications
- von Schulthess EL, Maunz A, Chakravarthy U, Holekamp N, Pauleikhoff D, Patel K, Bachmeier I, Yu S, Cohen Y, Scherb MP, Jones IL, Gibson K, Willis JR, Glittenberg C, Singh RP, Fauser S. Intraretinal Hyper-Reflective Foci Are Almost Universally Present and Co-Localize With Intraretinal Fluid in Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2024 May 1;65(5):26. doi: 10.1167/iovs.65.5.26.
- Sahni J, Patel SS, Dugel PU, Khanani AM, Jhaveri CD, Wykoff CC, Hershberger VS, Pauly-Evers M, Sadikhov S, Szczesny P, Schwab D, Nogoceke E, Osborne A, Weikert R, Fauser S. Simultaneous Inhibition of Angiopoietin-2 and Vascular Endothelial Growth Factor-A with Faricimab in Diabetic Macular Edema: BOULEVARD Phase 2 Randomized Trial. Ophthalmology. 2019 Aug;126(8):1155-1170. doi: 10.1016/j.ophtha.2019.03.023. Epub 2019 Mar 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Faricimab | Monoclonal antibody | 1.5 mg | Intravitreal |
| Subject | Faricimab | Monoclonal antibody | 6 mg | Intravitreal |
| Comparator | Ranibizumab | Monoclonal antibody | 0.3 mg | Intravitreal |