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Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Sponsor: Alcon Research
Summary
The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).
Official title: A Phase 1/2 Two-Stage Dose Escalation and Randomized Parallel-Group Study to Evaluate the Safety, Preliminary Treatment Effects, and Durability of AR-14034 Sustained Release Implant Compared to Intravitreal Anti-Vascular Endothelial Growth Factor Treatment in Participants With Neovascular Age-Related Macular Degeneration
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2023-12-06
Completion Date
2027-10
Last Updated
2026-01-06
Healthy Volunteers
No
Interventions
AR-14034 SR implant lower dose
AR-14034 SR administered as an intravitreal implant
AR-14034 SR implant higher dose
AR-14034 SR administered as an intravitreal implant
AR-14034 SR implant
AR-14034 SR administered as an intravitreal implant
Aflibercept Injection
Aflibercept administered as a 2 milligram (mg) intravitreal injection
Sham procedure
Needleless syringe used to simulate an intravitreal injection
Locations (42)
Trinity Research Group
Dothan, Alabama, United States
Associated Retina Consultants - Gilbert
Gilbert, Arizona, United States
Associated Retina Consultants - Phoenix
Phoenix, Arizona, United States
Retina Associates of SW PC
Tucson, Arizona, United States
The Retina Partners
Encino, California, United States
Retina Associates of Orange County
Laguna Hills, California, United States
Northern California Retina Vitreous Associates Medical Group
Mountain View, California, United States
Eye Research Foundation
Newport Beach, California, United States
Azul Vision Pasadena
Pasadena, California, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
Retina Group of New England | Waterford
Waterford, Connecticut, United States
Florida Retina Institute
Jacksonville, Florida, United States
Mid Florida Eye Center
Mt. Dora, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Thomas Eye Group Main Office
Sandy Springs, Georgia, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Twin Cities Eye Consultants
Coon Rapids, Minnesota, United States
Mississippi Retina Associates
Madison, Mississippi, United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, United States
NYC Retina - Queens
Forest Hills, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Verum Research, LLC
Eugene, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
MidAtlantic Retina Research
Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina
Greenville, South Carolina, United States
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates - Arlington
Arlington, Texas, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Star Vision Research
Burleson, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Berkeley Eye Center
Houston, Texas, United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, United States
Austin Retina Associates (San Marcos)
San Marcos, Texas, United States
Retina Research Center of Southern Utah
St. George, Utah, United States
Pacific Northwest Retina
Burlington, Washington, United States