A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Description

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

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Study Overview

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Study Details

Study overview

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients With Neovascular Age-Related Macular Degeneration

A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Condition
Neovascular Age-related Macular Degeneration (nAMD)
Intervention / Treatment

-

Contacts and Locations

Lemont

University Retina and Macula Associates, PC, Lemont, Illinois, United States, 60439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Overtly healthy as determined by medical evaluation that includes medical history and physical examination
  • * Agreement to adhere to the contraception requirements described in the protocol
  • * Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT)
  • * BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study \[ETDRS\] protocol and addressed at the initial testing distance of 4 meters on Day 1)
  • * Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
  • * MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
  • * Retinal pigment epithelial tear involving the macula on Day 1
  • * Current vitreous hemorrhage on Day 1
  • * Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor \[VEGF\], or complement inhibitor medication) for other retinal diseases
  • * Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits
  • * History of idiopathic or autoimmune associated uveitis in either eye
  • * Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2028-01-31