A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Phase 3

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Faricimab; Other: Sham Procedure

• Registration Number: NCT04777201
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study.

Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-02
• Study Start: 2021-04-19
• Primary Completion: 2024-09-03
• Study Completion: 2024-09-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1036

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main Study: Faricimab PTI	Sham Procedure	-
Substudy: Faricimab PTI	Faricimab	-
Main Study: Faricimab PTI	Faricimab	-

Primary Outcome Measures

Name	Time	Method
Main Study: Incidence and Severity of Systemic (Non-Ocular) Adverse Events	Up to 2 years
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye	Baseline and 1 year	1 Year is defined as the earliest substudy visit closest to Week 52 occurring between Week 48 and Week 64.
Main Study: Incidence and Severity of Ocular Adverse Events	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye	Baseline and Week 24	Week 24 is defined as the earliest substudy visit closest to Week 24 occurring between Week 20 and Week 28.

Trial Locations

Locations (254)

Barnet Dulaney Perkins Eye Center; 🇺🇸 Mesa, Arizona, United States

Arizona Retina and Vitreous Consultants; 🇺🇸 Phoenix, Arizona, United States

Associated Retina Consultants; 🇺🇸 Phoenix, Arizona, United States

Retina Associates Southwest PC; 🇺🇸 Tucson, Arizona, United States

Retinal Diagnostic Center; 🇺🇸 Campbell, California, United States

The Retina Partners; 🇺🇸 Encino, California, United States

South Coast Retina Center; 🇺🇸 Los Angeles, California, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

Southern CA Desert Retina Cons; 🇺🇸 Palm Desert, California, United States

California Eye Specialists Medical group Inc.; 🇺🇸 Pasadena, California, United States

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