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RECRUITING
NCT07482176
PHASE3

Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)

Sponsor: Adverum Biotechnologies, Inc.

View on ClinicalTrials.gov

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

GENETIC

Ixo-vec

Ixo-vec will be administered intravitreally.

DRUG

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