A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Rel… (NCT03823287) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)
United States, Canada, Germany671 participantsStarted 2019-02-19
Plain-language summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
* Ability to comply with the study protocol, in the investigator's judgment
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment
* Other protocol-specified inclusion criteria may apply
Exclusion Criteria:
* Uncontrolled blood pressure, defined as systolic blood pressure \>180 millimeters of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while a patient is at rest on Day 1
* Pregnancy or breastfeeding, or intention to become pregnant during the study
* CNV due to causes other than AMD in the study eye
* Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
* Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
* Uncontrolled glaucoma in the study eye
* Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
* Prior IVT administration of faricimab in either eye
* History of idiopathic or autoimmun…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared faricimab to an existing treatment for wet macular degeneration — can you tell me how the vision changes measured at weeks 40 to 48 compare to what I might expect from the standard treatments already available to me?
2Since this is a completed Phase 3 trial, does the published data show any safety signals or side effects related to faricimab that I should be aware of given my specific health history?
3The trial measured 'best corrected visual acuity' as its main outcome — can you help me understand what those kinds of changes actually mean for day-to-day vision, and whether the results would be meaningful for someone in my situation?
4Faricimab is being studied on a different dosing schedule than some current treatments — would that schedule be realistic for my life, and how does it compare to how often I'd need injections with the standard option you'd recommend for me?
5Given that this trial has completed, is faricimab now approved or accessible outside of a trial, and if not, are there other active studies or standard treatments you think I should consider first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48