Evaluating Faricimab for Treating Neovascular Age-Related Macular Degeneration
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
This study is testing a new eye injection called faricimab to see if it can help people with a specific type of age-related vision loss feel better and improve their sight.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | faricimab |
| Locations | 17 sites (Winter Haven, Florida and 16 other locations) |
| Trial ID | NCT06795048 on ClinicalTrials.gov |
What this trial studies
This Phase IV clinical trial investigates the efficacy, safety, and durability of faricimab, administered via intravitreal injection at intervals of up to 24 weeks, in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). The study is multicenter and randomized, involving two arms over a duration of 100 weeks. Participants will be evaluated for their response to the treatment based on the presence of intraretinal or subretinal fluid affecting the central subfield, as confirmed by optical coherence tomography (OCT).
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve patients diagnosed with active neovascular age-related macular degeneration.
Not a fit: Patients with macular neovascularization due to causes other than age-related macular degeneration may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision outcomes for patients with neovascular age-related macular degeneration.
How similar studies have performed: Other studies have shown promising results with similar treatments for neovascular age-related macular degeneration, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winter Haven, Florida and 16 other locations
- Ctr for Retina & Macular Dis — Winter Haven, Florida, United States (Recruiting)
- Retinal Vitreal Consultants — Chicago, Illinois, United States (Recruiting)
- University Retina and Macula Associates, PC — Lemont, Illinois, United States (Recruiting)
- New England Retina Consultants — Springfield, Massachusetts, United States (Recruiting)
- Retina Consultants of Texas — Schertz, Texas, United States (Recruiting)
- Strathfield Retina Clinic — Strathfield, New South Wales, Australia (Recruiting)
- Adelaide Eye and Retina Centre — Adelaide, South Australia, Australia (Recruiting)
- Centre For Eye Research Australia — East Melbourne, Victoria, Australia (Recruiting)
- Retina Specialists Victoria — Rowville, Victoria, Australia (Recruiting)
- The Lions Eye Institute — Nedlands, Western Australia, Australia (Recruiting)
- Retina Institute of Ottawa — Ottawa, Ontario, Canada (Recruiting)
- Toronto Retina Institute — Toronto, Ontario, Canada (Recruiting)
- Peking University People's Hospital — Beijing, China (Recruiting)
- Yeungnam Univ. Hospital — Daegu, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung, Taiwan (Recruiting)
- National Taiwan University Hospital — Zhongzheng Dist., Taiwan (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: MR45638 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.