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A Study to Determine Safety and Long-Term Effectiveness of Faricimab in Participants with Age-Related Macular Degeneration
EU CTIS ID: 2024-517545-13-00
What this study is testing
To evaluate the efficacy of intravitreal (IVT) injections of faricimab in the study eye following the regimen in each of the treatment arms as change from baseline in best corrected visual acuity (BCVA) averaged over Weeks 44, 48, and 52
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥50 years at the time of signing Informed Consent Form
- Overtly healthy as determined by medical evaluation that includes medical history and physical examination.
- Agreement to adhere to the contraception requirements described
- 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 OCT.
- Ocular Inclusion Criteria for Study Eye: 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).
- Ocular Inclusion Criteria for Study Eye:Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
You likely can't join if
- Macular neovascularization due to causes other than AMD, 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 will be excluded from study entry
- Ocular Exclusion for Both Eyes Potential participants are excluded from the study if any of the following criteria apply: – 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Australia
- Taiwan
- Korea, Republic of
- United States
- China
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; Australia; Taiwan; Korea, Republic of; United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.