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Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)
Sponsor: Adverum Biotechnologies, Inc.
Summary
This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to intravitreal aflibercept (active comparator). The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured as an average at Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.
Official title: A Multi-center, Randomized, Double-masked, Active-comparator-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
284
Start Date
2026-03-16
Completion Date
2031-10-20
Last Updated
2026-05-20
Healthy Volunteers
No
Interventions
Ixo-vec
Ixo-vec will be administered intravitreally.
Aflibercept
Aflibercept will be administered intravitreally.
Locations (46)
Adverum Clinical Site 126
Phoenix, Arizona, United States
Adverum Clinical Site 178
Phoenix, Arizona, United States
Adverum Clinical Site 223
Phoenix, Arizona, United States
Adverum Clinical Site 229
Scottsdale, Arizona, United States
Adverum Clinical Site 198
Springdale, Arkansas, United States
Adverum Clinical Site 109
Bakersfield, California, United States
Adverum Clinical Site 100
Beverly Hills, California, United States
Adverum Clinical Site 201
Campbell, California, United States
Adverum Clinical Site 172
Encino, California, United States
Adverum Clinical Site 169
Fullerton, California, United States
Adverum Clinical Site 224
Huntington Beach, California, United States
Adverum Clinical Site 215
Redlands, California, United States
Adverum Clinical Site 140
Sacramento, California, United States
Adverum Clinical Site 212
Sacramento, California, United States
Adverum Clinical Site 202
Torrance, California, United States
Adverum Clinical Site 189
Walnut Creek, California, United States
Adverum Clinical Site 116
Denver, Colorado, United States
Adverum Clinical Site 165
Waterford, Connecticut, United States
Adverum Clinical Site 124
Deerfield Beach, Florida, United States
Adverum Clinical Site 184
Deerfield Beach, Florida, United States
Adverum Clinical Site 176
Fort Lauderdale, Florida, United States
Adverum Clinical Site 221
Fort Myers, Florida, United States
Adverum Clinical Site 214
Lakeland, Florida, United States
Adverum Clinical Site 213
Orlando, Florida, United States
Adverum Clinical Site 183
South Miami, Florida, United States
Adverum Clinical Site 182
Augusta, Georgia, United States
Adverum Clinical Site 195
Carmel, Indiana, United States
Adverum Clinical Site 204
Hagerstown, Maryland, United States
Adverum Clinical Site 216
Jackson, Mississippi, United States
Adverum Clinical Site 225
Liverpool, New York, United States
Adverum Clinical Site 196
Asheville, North Carolina, United States
Adverum Clinical Site 211
Greensboro, North Carolina, United States
Adverum Clinical Site 219
Greensboro, North Carolina, United States
Adverum Clinical Site 220
Hickory, North Carolina, United States
Adverum Clinical Site 209
Wake Forest, North Carolina, United States
Adverum Clinical Site 241
Bluffton, South Carolina, United States
Adverum Clinical Site 222
Ladson, South Carolina, United States
Adverum Clinical Site 127
Austin, Texas, United States
Adverum Clinical Site 107
Conroe, Texas, United States
Adverum Clinical Site 194
Dallas, Texas, United States
Adverum Clinical Site 162
McAllen, Texas, United States
Adverum Clinical Site 232
San Marcos, Texas, United States
Adverum Clinical Site 228
Schertz, Texas, United States
Adverum Clinical Site 231
The Woodlands, Texas, United States
Adverum Clinical Site 237
Tyler, Texas, United States
Adverum Clinical Site 199
Lynchburg, Virginia, United States