Home OCT-guided treatment for neovascular AMD management
Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
This study tests if using home monitoring with a special eye scan can help people with neovascular age-related macular degeneration see better and make treatment easier compared to the usual method.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Jaeb Center for Health Research Academic / other |
| Drugs / interventions | faricimab |
| Locations | 64 sites (Glendale, California and 63 other locations) |
| Trial ID | NCT05904028 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two treatment approaches for managing neovascular age-related macular degeneration (nAMD): a home optical coherence tomography (OCT)-guided treatment strategy and a standard 'Treat and Extend' regimen. The study aims to determine if daily monitoring with home OCT can lead to better visual acuity outcomes and reduced treatment burden compared to traditional methods. Participants will receive intravitreal injections of faricimab while undergoing either treatment approach over a two-year period. The trial seeks to personalize treatment by utilizing home monitoring to optimize injection frequency and improve disease management.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with untreated, active macular neovascularization secondary to age-related macular degeneration.
Not a fit: Patients who have previously received treatment for macular neovascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved visual outcomes and reduced treatment burden for patients with neovascular AMD.
How similar studies have performed: Other studies have shown promise in using home monitoring technologies for chronic conditions, but this specific approach is novel in the context of nAMD management.
Eligibility criteria
Show full inclusion / exclusion criteria
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 MNV lesion (i.e., any intraretinal or subretinal fluid within the center 3 mm diameter circle on OCT) secondary to age-related macular degeneration * ≥ 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 * A condition that, in the opinion of the investigator, would preclude participation in the study or ability to complete daily Home OCT scans for 2 years (e.g., unstable medical status that may preclude successful completion of follow-up, dementia, Alzheimer's disease, uncontrollable tremors) * MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia
Where this trial is running
Glendale, California and 63 other locations
- Kent W. Small, MD, AMC — Glendale, California, United States (Recruiting)
- Loma Linda University — Loma Linda, California, United States (Recruiting)
- East Bay Retina Consultants, Inc. — Oakland, California, United States (Recruiting)
- Kaiser Permanente - Oakland — Oakland, California, United States (Recruiting)
- Southern California Desert Retina Consultants, Inc. — Palm Desert, California, United States (Recruiting)
- UC Davis Health Eye Center — Sacramento, California, United States (Recruiting)
- Macula Retina Vitreous Institute — Torrance, California, United States (Recruiting)
- Bay Area Retina Associates A Medical Group — Walnut Creek, California, United States (Recruiting)
- Retina Consultants — Manchester, Connecticut, United States (Recruiting)
- National Ophthalmic Research Institute — Fort Myers, Florida, United States (Recruiting)
- National Ophthalmic Research Institute — Fort Myers, Florida, United States (Recruiting)
- University of Florida- Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Florida Retina Institute, James A. Staman, MD, PA- Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Argus Research Center, Inc — Naples, Florida, United States (Recruiting)
- Southeast Eye Institute, P.A. dba Eye Associates of Pinellas — Pinellas Park, Florida, United States (Recruiting)
- Retina Associates of Sarasota — Sarasota, Florida, United States (Recruiting)
- Sarasota Retina Institute — Sarasota, Florida, United States (Recruiting)
- Retina Associates of Florida, LLC — Tampa, Florida, United States (Recruiting)
- Southeast Retina Center, P.C. — Augusta, Georgia, United States (Recruiting)
- Thomas Eye Group — Sandy Springs, Georgia, United States (Recruiting)
- Northwestern Memorial Group — Chicago, Illinois, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- UIC - Dept of Ophthalmology & Visual Sciences — Chicago, Illinois, United States (Recruiting)
- The Trustees of Indiana University — Indianapolis, Indiana, United States (Recruiting)
- Midwest Eye Institute — Indianapolis, Indiana, United States (Recruiting)
- Wolfe Clinic, P.C.- West Des Moines — West Des Moines, Iowa, United States (Recruiting)
- Mid-America Retina Consultants, P.A. — Overland Park, Kansas, United States (Recruiting)
- University of Kentucky Advanced Eye Care — Lexington, Kentucky, United States (Recruiting)
- Elman Retina Group, BA — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Valley Eye Physicians and Surgeons — Ayer, Massachusetts, United States (Recruiting)
- Joslin Diabetes Center — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- Retina Associates of Michigan — Grand Blanc, Michigan, United States (Recruiting)
- Associated Retinal Consultants, P.C. — Royal Oak, Michigan, United States (Recruiting)
- Associated Retinal Consultants — Traverse City, Michigan, United States (Recruiting)
- The Retina Institute — St Louis, Missouri, United States (Recruiting)
- Associated Retinal Surgeons d/b/a Mid Atlantic Retina — Cherry Hill, New Jersey, United States (Recruiting)
- New York University Langone Health — New York, New York, United States (Recruiting)
- Macula Care — New York, New York, United States (Recruiting)
- Vitreous Retina Macula Consultants of NY - VRMNY — New York, New York, United States (Recruiting)
- Retina Associates of Western NY, P.C. — Rochester, New York, United States (Recruiting)
- The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine — Cleveland, Ohio, United States (Recruiting)
- Retina Vitreous Center — Edmond, Oklahoma, United States (Recruiting)
- Verum Research LLC — Eugene, Oregon, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- Cascade Medical Research Institute, LLC — Springfield, Oregon, United States (Recruiting)
- Retina Vitreous Consultants — Monroeville, Pennsylvania, United States (Recruiting)
- The Trustees of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Hilton Head Retina Institute — Hilton Head Island, South Carolina, United States (Recruiting)
+14 more sites — see ClinicalTrials.gov for the full list.
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.