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

May 3, 2024 updated by: Jaeb Center for Health Research
Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Treatment of Neovascular Age-Related Macular Degeneration (nAMD) with anti-vascular endothelial growth factor therapy is highly effective but is associated with considerable treatment burden and cost for patients and the healthcare system. One of the principal barriers to reducing burden and cost is that the optimal number of injections needed to achieve best visual acuity and disease control for any one person is unknown. At present, there are several algorithms that modestly reduce treatment burden, but at the expense of overtreatment in some patients and less optimal disease control in others. The lack of precision in disease management may be due in part to the low frequency of disease monitoring, which typically occurs every one to two months by standard optical coherence tomography (OCT) imaging during an office visit. Home OCT imaging allows daily disease activity monitoring and the possibility of a tailored and more personalized approach to managing neovascular AMD. To understand the role of Home OCT in clinical practice, it is essential to perform a randomized clinical trial that compares visual acuity outcomes, and visit and injection frequencies, obtained using a Home OCT-guided treatment strategy versus outcomes obtained using "Treat and Extend," the treatment algorithm widely perceived to be the most common regimen in clinical practice today.

The main objective of this study is to determine if Home OCT-guided treatment results in 1) better visual acuity outcomes and/or 2) fewer number of injections over 104 weeks compared with treat and extend (T&E) dosing for nAMD.

Upon completion of baseline testing procedures, eligible study eyes will enter the run-in phase and be given an injection of faricimab. The participant will be provided with a post-injection instruction sheet and will be reminded that the site will follow-up regarding eligibility for the randomization phase. The Notal Vision Monitoring Center must confirm adequate scan quality from the study eye prior to randomization. Once Notal Vision Monitoring Center confirms acceptable scans, randomization can be completed. The participant does not need to be present in the office for randomization. Randomization of eligible study eyes must occur within 10 days of the baseline visit. Prior to randomization, the site must call the participant to confirm they are still willing to participate and agree to follow the daily Home OCT scan requirement if randomized to the Home OCT group. Sites will also confirm the participant's understanding of the trial, willingness to accept the assigned treatment group, and commitment to the follow-up schedule, and compliance with device use.

Procedures at the baseline visit include eligibility assessment, vision testing, ocular examination, various imaging, and test session on the in-office Home OCT device. Eligible study eyes will enter the run-in phase and receive a baseline intravitreal faricimab injection. Participants must meet criteria for successful scanning as confirmed by Notal Vision for eligibility into the randomization phase. Eyes eligible for the randomization phase will be randomly assigned 1:1 into one of two groups to guide follow-up treatment: (1) Treat and Extend or (2) Home OCT-guided treatment.

Eyes receiving an initial faricimab injection that are not eligible for the randomization phase will have a final closeout safety visit 1 month after injection. For eyes in the randomization phase, follow-up for treatment group comparisons of vision and imaging outcomes will occur at 52- and 104-week visits. Additional visits will occur every 4-18 weeks in the T&E group. Participants assigned to the Home OCT group will self-scan daily using the Home OCT device and will only return for a visit if fluid passing the threshold for an office visit is seen on Home OCT. Follow-up visit procedures include vision testing, ocular exam, and various imaging. The primary outcomes are a comparison of mean change in visual acuity and number of injections from baseline to 104 weeks between the Home OCT vs. T&E groups (study eye only).

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91203-1971
        • Recruiting
        • Kent W. Small, MD, AMC
        • Contact:
      • Oakland, California, United States, 94609
        • Recruiting
        • East Bay Retina Consultants, Inc.
        • Contact:
      • Palm Desert, California, United States, 92211
        • Recruiting
        • Southern California Desert Retina Consultants, Inc.
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Health Eye Center
        • Contact:
      • Torrance, California, United States, 90503
        • Recruiting
        • Macula Retina Vitreous Institute
        • Contact:
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Bay Area Retina Associates A Medical Group
        • Contact:
    • Connecticut
      • Manchester, Connecticut, United States, 06042
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • National Ophthalmic Research Institute
        • Contact:
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida- Jacksonville
        • Contact:
      • Sarasota, Florida, United States, 34233
        • Recruiting
        • Retina Associates of Sarasota
        • Contact:
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Retina Associates of Florida, LLC
        • Contact:
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Southeast Retina Center, P.C.
        • Contact:
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Wolfe Clinic, P.C.- West Des Moines
        • Contact:
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Mid-America Retina Consultants, P.A.
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • Elman Retina Group, BA
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Joslin Diabetes Center
        • Contact:
          • Lloyd P Aiello, MD, PhD
          • Phone Number: 614-309-2520
    • Missouri
      • Saint Louis, Missouri, United States, 63128
    • New York
      • Rochester, New York, United States, 14620
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Retina Vitreous Center
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Verum Research LLC
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29926
        • Recruiting
        • Hilton Head Retina Institute
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Recruiting
        • Southeastern Retina Associates, P.C.
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030-4101
        • Recruiting
        • Baylor College of Medicine, Baylor Eye Physicians and Surgeons
        • Contact:
      • Lubbock, Texas, United States, 79424
      • San Antonio, Texas, United States, 78240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Age ≥ 50 years
  • Have the capacity to consent on his/her own behalf
  • Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site
  • Willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days)
  • Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20/320 or better (Snellen))
  • Previously untreated, active macular neovascularization (MNV) lesion (i.e., any intraretinal or subretinal fluid on OCT) secondary to age-related macular degeneration
  • MNV or sequelae of the MNV (i.e., pigment epithelium detachment, subretinal or sub-RPE hemorrhage, or subretinal, sub-RPE or intraretinal fluid) involving the foveal center
  • ≥ 1 intermediate drusen (>63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye

Key Exclusion Criteria for Study Eye:

  • Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent, or any other AMD therapy)
  • Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication
  • Treatment with intravitreal corticosteroids within the last 6 months
  • Any condition that may preclude adequate imaging of the macula (e.g., dense cataract or other media opacity, severe ptosis)
  • MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treat and Extend
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Drug: Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Experimental: Home optical coherence tomography-Guided Treatment
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Device: Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Other Names:
  • Home OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E-ETDRS Change in Visual Acuity Letter Score
Time Frame: Baseline to 104 weeks
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity.
Baseline to 104 weeks
Number of intravitreal injections of Faricimab (6.0 mg) in the study eye
Time Frame: Baseline to 104 weeks
Baseline to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

Juvenile Diabetes Research Foundation
National Eye Institute (NEI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol AO
  • UG1EY014231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neovascular Age-related Macular Degeneration

Clinical Trials on Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe