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Actively Recruiting

Phase 3
Age: 50Years +
All Genders
ID05904028

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular Age-Related Macular Degeneration

Led by Jaeb Center for Health Research · Updated on 2026-05-18

600

Participants Needed

65

Research Sites

N/A

Total Duration

On this page

Sponsors

J

Jaeb Center for Health Research

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two approaches for managing neovascular age-related macular degeneration nAMD to find out if home optical coherence tomography OCT-guided treatment improves visual outcomes or reduces the number of injections compared to the common Treat and Extend dosing method. The study addresses the current challenge of determining the optimal number of anti-vascular endothelial growth factor anti-VEGF injections needed for each patient, aiming to reduce treatment burden and costs by allowing more personalized care through daily monitoring with home OCT. Participants will receive intravitreal injections of 6 mg faricimab and be randomly assigned to either the Treat and Extend group or the Home OCT-guided treatment group. The Treat and Extend group will have office visits every 4 to 18 weeks for vision testing and imaging, while the Home OCT group will perform daily self-scans at home and only return for visits when disease activity is detected by the home device. The study includes a baseline phase with initial injection and imaging confirmation before randomization, followed by 104 weeks of treatment and monitoring. During the study, participants will undergo vision tests, eye exams, and various imaging procedures at scheduled visits or as triggered by home OCT scans. Researchers will track changes in visual acuity and count the number of injections over two years. Close monitoring ensures scan quality and disease status before randomization. The study measures include the change in visual acuity letter score and total injections received, aiming to compare the effectiveness and treatment burden between the two methods over 104 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Ability to provide informed consent independently
  • Ability to successfully complete at least one self-scanning session on the Home OCT device at the study site
  • Willingness to perform daily Home OCT monitoring tests for 2 years without significant interruption
  • Best corrected visual acuity of 24 ETDRS letters (approximately 20/320 Snellen) or better
  • Presence of previously untreated, active macular neovascularization lesion with intraretinal or subretinal fluid in the center 3 mm diameter on OCT
  • At least one intermediate drusen (63 microns or larger) in either eye or late age-related macular degeneration in the other eye
Not Eligible

You will not qualify if you...

  • Previous treatment for macular neovascularization including any intravitreal anti-VEGF or anti-Ang2 injections or other AMD therapies
  • Prior treatment with macular laser for any reason
  • Treatment with intravitreal corticosteroids within the last 6 months
  • Medical or neurological conditions that prevent participation or daily Home OCT scans for 2 years (e.g., unstable health, dementia, Alzheimer's disease, uncontrollable tremors)
  • Macular neovascularization caused by conditions other than age-related macular degeneration such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia

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