A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Public ClinicalTrials.gov record NCT04777201. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study. Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.
Study identification
- NCT ID
- NCT04777201
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,036 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 19, 2021 (Actual)
- Primary completion
- Sep 3, 2024 (Actual)
- Completion
- Sep 3, 2024 (Actual)
- Last update posted
- Oct 24, 2025
2021 – 2024
United States locations
- U.S. sites
- 85
- U.S. states
- 29
- U.S. cities
- 78
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Mesa | Arizona | 85206 | — |
| Arizona Retina and Vitreous Consultants | Phoenix | Arizona | 85016 | — |
| Associated Retina Consultants | Phoenix | Arizona | 85020 | — |
| Retina Associates Southwest PC | Tucson | Arizona | 85704 | — |
| Retinal Diagnostic Center | Campbell | California | 95008 | — |
| The Retina Partners | Encino | California | 91436 | — |
| South Coast Retina Center | Los Angeles | California | 90033 | — |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | — |
| Southern CA Desert Retina Cons | Palm Desert | California | 92211 | — |
| California Eye Specialists Medical group Inc. | Pasadena | California | 91107 | — |
| Retina Consultants, San Diego | Poway | California | 92064 | — |
| Retina Consultants of Southern California | Redlands | California | 92373 | — |
| University of California, Davis, Eye Center | Sacramento | California | 95817 | — |
| Retinal Consultants Med Group | Sacramento | California | 95825 | — |
| Orange County Retina Med Group | Santa Ana | California | 92705 | — |
| California Retina Consultants | Santa Barbara | California | 93103 | — |
| Retina Consultants of Southern | Colorado Springs | Colorado | 80909 | — |
| Colorado Retina Associates, PC | Lakewood | Colorado | 80228 | — |
| Retina Group of New England | Waterford | Connecticut | 06385 | — |
| Rand Eye | Deerfield Beach | Florida | 33064 | — |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | — |
| Florida Eye Associates | Melbourne | Florida | 32901 | — |
| Retina Care Specialists | Palm Beach Gardens | Florida | 33410 | — |
| Retina Specialty Institute | Pensacola | Florida | 32503 | — |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | — |
| Retina Vitreous Assoc of FL | St. Petersburg | Florida | 33711 | — |
| Southern Vitreoretinal Assoc | Tallahassee | Florida | 32308 | — |
| Retina Associates of Florida, LLC | Tampa | Florida | 33609 | — |
| Southeast Retina Center | Augusta | Georgia | 30909 | — |
| Georgia Retina PC | Marietta | Georgia | 30060 | — |
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | — |
| Northwestern Medical Group/Northwestern University | Chicago | Illinois | 60611 | — |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | — |
| Prairie Retina Center | Springfield | Illinois | 62704 | — |
| Raj K. Maturi, MD PC | Indianapolis | Indiana | 46290 | — |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | — |
| Retina Associates | Lenexa | Kansas | 66215 | — |
| Maine Eye Center | Portland | Maine | 04101 | — |
| Retina Specialists | Baltimore | Maryland | 21204 | — |
| The Retina Care Center | Baltimore | Maryland | 21209 | — |
| Johns Hopkins Med | Baltimore | Maryland | 21287 | — |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | — |
| VitreoRetinal Surgery, PLLC. | Edina | Minnesota | 55435 | — |
| Midwest Vision Research Foundation | Chesterfield | Missouri | 63017 | — |
| Retina Associates of St. Louis | Florissant | Missouri | 63031 | — |
| Sierra Eye Associates | Reno | Nevada | 89502 | — |
| Mid Atlantic Retina - Wills Eye Hospital | Cherry Hill | New Jersey | 08034 | — |
| NJ Retina | Edison | New Jersey | 08820 | — |
| Retina Associates of NJ | Teaneck | New Jersey | 07666 | — |
| Long Is. Vitreoretinal Consult | Great Neck | New York | 11021 | — |
| Ophthalmic Cons of Long Island | Oceanside | New York | 11572 | — |
| Retina Assoc of Western NY | Rochester | New York | 14620 | — |
| Vitreoretinal Consultants of New York | Shirley | New York | 11967 | — |
| The Retina Consultants | Slingerlands | New York | 12159 | — |
| Retina Vit Surgeons/Central NY | Syracuse | New York | 13224 | — |
| Western Carolina Retinal Associate PA | Asheville | North Carolina | 28803 | — |
| Char Eye Ear &Throat Assoc | Charlotte | North Carolina | 28210 | — |
| Graystone Eye | Winston-Salem | North Carolina | 27104 | — |
| Cincinnati Eye Institute | Blue Ash | Ohio | 45242-5537 | — |
| Retina Assoc of Cleveland Inc | Cleveland | Ohio | 44122 | — |
| The Ohio State University Havener Eye Institute | Columbus | Ohio | 43212 | — |
| Midwest Retina | Dublin | Ohio | 43016 | — |
| Retina Northwest | Portland | Oregon | 97221 | — |
| Charleston Neuroscience Inst | Ladson | South Carolina | 29456 | — |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | — |
| Black Hills Eye Institute | Rapid City | South Dakota | 57701 | — |
| Southeastern Retina Associates Chattanooga | Chattanooga | Tennessee | 37421 | — |
| Charles Retina Institute | Germantown | Tennessee | 38138 | — |
| Tennessee Retina PC. | Nashville | Tennessee | 37203 | — |
| Retina Res Institute of Texas | Abilene | Texas | 79606 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Austin Clinical Research LLC | Austin | Texas | 78750 | — |
| Texas Retina Associates | Dallas | Texas | 75231 | — |
| Retina Consultants of Texas | Houston | Texas | 77030 | — |
| Valley Retina Institute P.A. | McAllen | Texas | 78503 | — |
| Retina Center of Texas | Southlake | Texas | 76092 | — |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | — |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | — |
| Retina Associates of Utah, PLLC | Salt Lake City | Utah | 84107 | — |
| Rocky Mountain Retina | Salt Lake City | Utah | 84107 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
| Wagner Kapoor Institute | Norfolk | Virginia | 23451 | — |
| Pacific Northwest Retina | Silverdale | Washington | 98383 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 166 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04777201, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 24, 2025 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04777201 live on ClinicalTrials.gov.