A Study to Determine the Efficacy, Safety, and Durability... | NCT06795048

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

NCT06795048

Sponsor

Hoffmann-La Roche

Status

Active, not recruiting

Last Update Posted

Apr 30, 2026Actual

Enrollment

274Estimated

Phase

Phase 4

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Interventions

Faricimab

Countries

United States
Australia
Canada
China
France
Germany
Italy
Singapore
South Korea
Spain
Taiwan
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2024-517545-13-00	Registry Identifier	EU CT Number

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2025Actual

Primary Completion Date

Oct 15, 2026Estimated

Completion Date

Sep 16, 2027Estimated

First Submitted Date

Jan 24, 2025

First Submission Date that Met QC Criteria

Jan 24, 2025

First Posted Date

Jan 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

Apr 30, 2026Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

274Estimated

Label	Type	Description	Intervention Names
Arm A: Faricimab Early Treat & Extend Regimen	Experimental		Drug: Faricimab
Arm B: Faricimab Modified Treat & Extend Regimen	Experimental		Drug: Faricimab

Name	Type	Description	Arm Group Labels	Other Names
Faricimab	Drug	Participants will receive 6-mg faricimab intravitreal (IVT) injections in the study eye according to the dosing regimen for the study arm to which they are randomized.

Measure	Description	Time Frame
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52		Baseline and average of Weeks 44, 48, and 52

Measure	Description	Time Frame
Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100		Baseline and average of Weeks 92, 96, and 100
Change from Baseline in BCVA Score Over Time		From Baseline to Week 100

Eligibility Module

Eligibility Criteria

Inclusion 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

Ocular Inclusion Criteria for Study Eye:

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

Exclusion Criteria:

Ocular Exclusion Criteria for Study Eye:

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

Ocular Exclusion Criteria for Fellow (Non-Study) Eye:

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

Ocular Exclusion for Both Eyes:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Orange County Retina Medical Group		Santa Ana	California	92705	United States
Florida Retina Institute

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided