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Monoclonal Antibodies

Faricimab Schedules for Age-Related Macular Degeneration (AO Trial)

Phase 3
Recruiting
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 1 intermediate drusen (>63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye
Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site
Must not have
Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication
Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent, or any other AMD therapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 104 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two different approaches for treating age-related macular degeneration using a type of imaging called optical coherence tomography.

Who is the study for?
This trial is for people over 50 with neovascular age-related macular degeneration (AMD) who haven't been treated before. Participants must be able to consent, use a home OCT device independently, and commit to daily monitoring tests for 2 years. They should have some vision left (20/320 or better) and AMD-related changes in the eye.
What is being tested?
The study compares two ways of using faricimab injections for AMD: one group follows a Treat and Extend schedule at the clinic, while the other uses home OCT scans to decide when treatments are needed.
What are the potential side effects?
Faricimab injections can cause eye irritation, increased intraocular pressure, bleeding inside the eye, infection risk after injection, and possibly retinal detachment or cataracts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a certain type of eye condition affecting my vision.
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I can use the Home OCT device by myself for a scanning session.
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I have macular degeneration with specific complications affecting the center of my vision.
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I am 50 years old or older.
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I can make my own medical decisions.
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I have an untreated eye condition due to aging that causes fluid buildup.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had eye injections or laser treatment for eye conditions.
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I have received eye injections for macular degeneration before.
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I have not had eye injections with steroids in the last 6 months.
Select...
My vision loss is due to conditions like histoplasmosis, not aging.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 104 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
E-ETDRS Change in Visual Acuity Letter Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treat and ExtendExperimental Treatment1 Intervention
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Group II: Home optical coherence tomography-Guided TreatmentExperimental Treatment1 Intervention
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule

Find a Location

Who is running the clinical trial?

Jaeb Center for Health ResearchLead Sponsor
158 Previous Clinical Trials
34,989 Total Patients Enrolled
National Eye Institute (NEI)NIH
558 Previous Clinical Trials
1,407,871 Total Patients Enrolled
78 Trials studying Macular Degeneration
72,072 Patients Enrolled for Macular Degeneration
Juvenile Diabetes Research FoundationOTHER
235 Previous Clinical Trials
141,753 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,020 Total Patients Enrolled
2 Trials studying Macular Degeneration
161 Patients Enrolled for Macular Degeneration
~400 spots leftby Jul 2027
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