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Monoclonal Antibodies

Treat and Extend 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 104 weeks

Awards & highlights

AO 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.Check my eligibility

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.See study design

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.

AO Trial 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.

AO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 104 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

E-ETDRS Change in Visual Acuity Letter Score

Number of intravitreal injections of Faricimab (6.0 mg) in the study eye

AO 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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jaeb Center for Health ResearchLead Sponsor

153 Previous Clinical Trials

34,311 Total Patients Enrolled

National Eye Institute (NEI)NIH

547 Previous Clinical Trials

1,401,557 Total Patients Enrolled

Juvenile Diabetes Research FoundationOTHER

232 Previous Clinical Trials

141,184 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit in terms of patient enrollment for this medical study?

"A total of 600 eligible individuals are needed to enroll in this investigation as per the outlined criteria. Potential participants may join the research from varied locations, including Kent W. Small, MD, AMC situated in Glendale, Florida and the National Ophthalmic Research Institute located in Fort Myers, Georgia."

Answered by AI

At how many distinct locations is this medical trial being administered?

"Thirteen clinical sites are actively participating in this trial, including locations such as Kent W. Small, MD, AMC in Glendale; National Ophthalmic Research Institute in Fort Myers; and Retina Associates of Sarasota in Sarasota. Additional centers are also involved across 13 other diverse locations."

Answered by AI

Has the treatment and extension method been officially sanctioned by the FDA?

"Our team at Power has assessed the safety of the Treat and Extend approach to be a 3 on our scale. This rating indicates that, being in Phase 3, there is existing efficacy data along with substantial evidence supporting its safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

2023. "Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05904028.