A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Summary

This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study was designed to allow the evaluation of RO6867461 in a treatment-naive population (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per participant was chosen as the study eye.

Timeline

Start

2015-08-11

Primary completion

2017-09-26

Completion

2017-09-26

Outcome

Missed primary endpoint

paper AVENUE did not meet its primary end point of superiority of faricimab over ranibizumab in BCVA at week 36. PMID 32729888 ↗

registry Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) vs Arm B: Faricimab, 1.5 mg Q4W; p = 0.5244; Difference in Least Squares Means 1.57 (80% CI -1.60 to 4.74) NCT02484690 ↗

registry Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) vs Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W; p = 0.3034; Difference in Least Squares Means -1.68 (80% CI -3.77 to 0.42) NCT02484690 ↗

Publications

• Kikuchi Y, Kawczynski MG, Anegondi N, Neubert A, Dai J, Ferrara D, Quezada-Ruiz C. Machine Learning to Predict Faricimab Treatment Outcome in Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2023 Aug 18;4(2):100385. doi: 10.1016/j.xops.2023.100385. eCollection 2024 Mar-Apr.
• Yu S, Bachmeier I, Hernandez-Sanchez J, Garcia Armendariz B, Ebneter A, Pauleikhoff D, Chakravarthy U, Fauser S. Hyperreflective Material Boundary Remodeling in Neovascular Age-Related Macular Degeneration: A Post Hoc Analysis of the AVENUE Trial. Ophthalmol Retina. 2023 Nov;7(11):990-998. doi: 10.1016/j.oret.2023.06.024. Epub 2023 Jul 6.
• Maunz A, Benmansour F, Li Y, Albrecht T, Zhang YP, Arcadu F, Zheng Y, Madhusudhan S, Sahni J. Accuracy of a Machine-Learning Algorithm for Detecting and Classifying Choroidal Neovascularization on Spectral-Domain Optical Coherence Tomography. J Pers Med. 2021 Jun 8;11(6):524. doi: 10.3390/jpm11060524.
• Sahni J, Dugel PU, Patel SS, Chittum ME, Berger B, Del Valle Rubido M, Sadikhov S, Szczesny P, Schwab D, Nogoceke E, Weikert R, Fauser S. Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):955-963. doi: 10.1001/jamaophthalmol.2020.2685.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Faricimab	Monoclonal antibody	1.5 mg	Intravitreal
Subject	Faricimab	Monoclonal antibody	6 mg	Intravitreal
Subject	Ranibizumab	Monoclonal antibody	0.5 mg	Intravitreal

Indications