Clinical trial NCT06795048: A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 274
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52
timeFrame: Baseline and average of Weeks 44, 48, and 52
Secondary outcomes:
measure: Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100
timeFrame: Baseline and average of Weeks 92, 96, and 100
measure: Change from Baseline in BCVA Score Over Time
timeFrame: From Baseline to Week 100
measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time
timeFrame: From Baseline to Week 100
measure: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
timeFrame: From Baseline to Week 100
measure: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
timeFrame: From Baseline to Week 100
measure: Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52
timeFrame: Baseline and average of Weeks 44, 48, and 52
measure: Change from Baseline in CST Averaged Over Weeks 92, 96, and 100
timeFrame: Baseline and average of Weeks 92, 96, and 100
measure: Change from Baseline in CST Over Time
timeFrame: From Baseline to Week 100
measure: Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100
timeFrame: Weeks 52 and 100
measure: Incidence and Severity of Ocular Adverse Events
timeFrame: From first study treatment to Week 100
measure: Incidence and Severity of Non-Ocular Adverse Events
timeFrame: From first study treatment to Week 100
Other outcomes:
Locations:
city: Winter Haven
country: United States
facility: Ctr for Retina & Macular Dis
state: Florida
city: Chicago
country: United States
facility: Retinal Vitreal Consultants
state: Illinois
city: Lemont
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Springfield
country: United States
facility: New England Retina Consultants
state: Massachusetts
city: Schertz
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Adelaide
country: Australia
facility: Adelaide Eye and Retina Centre
state: South Australia
city: East Melbourne
country: Australia
facility: Centre For Eye Research Australia
state: Victoria
city: Rowville
country: Australia
facility: Retina Specialists Victoria
state: Victoria
city: Nedlands
country: Australia
facility: The Lions Eye Institute
state: Western Australia
city: Ottawa
country: Canada
facility: Retina Institute of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
city: Beijing
country: China
facility: Peking University People's Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univ. Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Zhongzheng Dist.
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: