At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory, Prospective, Multi-Center, Open-Label, Single-Arm, Interventional, Phase IIB Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Patients With Diabetic Macular Edema Treated With Faricimab (RO6867461) - ALTIMETER STUDY
In Brief
A Phase 2 clinical trial evaluating Faricimab for Diabetic Macular Edema. Completed, enrolled 99 participants across 23 sites in 7 countries.
Signals
Detailed Summary
This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor (AH) biomarker patterns, and genetic polymorphisms in participants with diabetic macular edema (DME) who are treated with faricimab.
Study Details
Timeline
Arms & Interventions
Participants will receive 6 doses (one 6 mg faricimab intravitreal \[IVT\] injection every 28 days \[Q4W\]) starting at Day 1 and ending on the Day 140 visit. Participants will return for a safety follow-up visit (SFV) after ≥28 days and within \<35 days following their last study treatment.
Interventions
A 6-milligram (mg) dose of faricimab will be administered intravitreally (IVT) in the study eye once every 4 weeks (Q4W).