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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Adverum Biotechnologies, Inc. • ClinicalTrials.gov ID: NCT07482176

Registry updated: 2026-09-24
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Description

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.

Interventions

  • Ixo-vec (Genetic)
    Ixo-vec will be administered intravitreally.
  • Aflibercept (Drug)
    Aflibercept will be administered intravitreally.

Eligibility criteria

Inclusion Criteria: 1. Able and willing to provide informed consent (or have a legally authorized representative who is able and willing to provide informed consent) prior to any study assessments and procedures and comply with the study requirements and visits. 2. Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMD disease activity at Screening Visit 1. 3. At least 50 years old at Screening Visit 1. 4. An ETDRS BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at Screening Visit 1. 5. Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening. 6. Able to reliably use eye drops per protocol. Exclusion Criteria: General Exclusion Criteria 1. History of a medical condition giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's ability to comply with the planned study activities, or that might affect the interpretation of the results of the study or render the participant at high risk for treatment complications in the opinion of the Investigator. History of severe coronavirus disease (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any important complications. 2. Received any prior gene therapy. 3. Prior treatment with any non-gene therapy investigational medicinal product (IMP) or medical device in the study eye within 3 months of Screening Visit 1 or 5 half-lives of the IMP prior to dosing with Ixo-vec, whichever is longer. 4. Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future. 5. History or evidence of any of the following cardiovascular diseases: 1. Myocardial infarction in the 6-month period prior to Week 1. 2. Uncontrolled hypertension defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg during screening. 3. Stroke in the 6-month period prior to Week 1. 6. History of ongoing bleeding disorders. The use of aspirin or other anticoagulants (e.g., Factor Xa inhibitors) is permitted. 7. Use of systemic immunosuppressive drugs within 90 days prior to Screening Visit 1. Short courses of oral corticosteroids are permitted, as well as any inhaled, intra-articular, nasal or dermal steroid use. 8. Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% during screening. Ocular Exclusion Criteria 1. Any active ocular or periocular infection in the study eye from Screening Visit 1. 2. History or evidence of the following in the study eye: 1. Intraocular or refractive surgery within 5 months prior to Week 1. 2. Any previous penetrating keratoplasty or vitrectomy. 3. Any previous panretinal photocoagulation. 4. Any previous submacular surgery, other surgical intervention (including port delivery system) or laser treatment for age-related macular degeneration. 3. Any history or evidence of retinal detachment (with or without repair) or retinal pigment epithelium rip/tear in the study eye, as determined by the Investigator during screening or at Week 1. 4. Uncontrolled ocular hypertension or glaucoma in the study eye from Screening Visit 1 to Week 1 or current use of ≥ 2 intraocular pressure (IOP) lowering medications or normal tension glaucoma/suspect in the study eye or history of any of the following procedures in the study eye prior to Week 1: 1. Incisional glaucoma surgery (i.e., glaucoma drainage implant/shunt or trabeculectomy) 2. Ocular angle-based surgery (i.e., goniotomy or canaloplasty) 3. Minimally Invasive Glaucoma Surgery (MIGS) in the study eye. 4. Angle-based glaucoma surgery (e.g., Argon or Selective Laser Trabeculoplasty) 5. Any history of IOP elevation related to topical steroid administration in either eye. 6. Any history of uveitis or inflammation (grade trace or above) except mild anticipated post operative inflammation that resolved in either eye. 7. Any history of treatment with complement inhibitors for geographic atrophy in the study eye. 8. Known history of ocular herpes simplex virus, varicella-zoster virus, or cytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye.

Conditions

Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD

Locations

  • Adverum Clinical Site 245 — Mesa, Arizona, United States
  • 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 242 — Sun City, 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 130 — Poway, 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 175 — Santa Barbara, California, United States
  • Adverum Clinical Site 202 — Torrance, California, United States
  • Adverum Clinical Site 189 — Walnut Creek, California, United States
  • Adverum Clinical Site 200 — Denver, Colorado, 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 236 — Gainesville, Florida, United States
  • Adverum Clinical Site 214 — Lakeland, Florida, United States
  • Adverum Clinical Site 168 — Miami Springs, Florida, United States
  • Adverum Clinical Site 213 — Orlando, Florida, United States
  • Adverum Clinical Site 206 — Plantation, Florida, United States
  • Adverum Clinical Site 183 — South Miami, Florida, United States
  • Adverum Clinical Site 120 — St. Petersburg, Florida, United States
  • Adverum Clinical Site 148 — Tampa, Florida, United States
  • Adverum Clinical Site 238 — Winter Haven, Florida, United States
  • Adverum Clinical Site 182 — Augusta, Georgia, United States
  • Adverum Clinical Site 246 — Chicago, Illinois, United States
  • Adverum Clinical Site 179 — Oak Forest, Illinois, United States
  • Adverum Clinical Site 207 — Oak Park, Illinois, United States
  • Adverum Clinical Site 195 — Carmel, Indiana, United States
  • Adverum Clinical Site 205 — Carmel, Indiana, United States
  • Adverum Clinical Site 253 — Carmel, Indiana, United States
  • Adverum Clinical Site 197 — Hagerstown, Maryland, United States
  • Adverum Clinical Site 204 — Hagerstown, Maryland, United States
  • Adverum Clinical Site 216 — Jackson, Mississippi, United States
  • Adverum Clinical Site 240 — Bloomfield, New Jersey, United States
  • Adverum Clinical Site 171 — Teaneck, New Jersey, United States
  • Adverum Clinical Site 225 — Liverpool, New York, United States
  • Adverum Clinical Site 244 — Rochester, New York, United States
  • Adverum Clinical Site 196 — Asheville, North Carolina, United States
  • Adverum Clinical Site 234 — Cary, 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 248 — Beachwood, Ohio, United States
  • Adverum Clinical Site 247 — Cleveland, Ohio, United States
  • Adverum Clinical Site 254 — Edmond, Oklahoma, United States
  • Adverum Clinical Site 252 — Portland, Oregon, United States
  • Adverum Clinical Site 181 — Erie, Pennsylvania, United States
  • Adverum Clinical Site 239 — Philadelphia, Pennsylvania, United States
  • Adverum Clinical Site 110 — Philadelphia, Pennsylvania, United States
  • Adverum Clinical Site 241 — Bluffton, South Carolina, United States
  • Adverum Clinical Site 222 — Ladson, South Carolina, United States
  • Adverum Clinical Site 101 — Nashville, Tennessee, United States
  • Adverum Clinical Site 145 — Arlington, Texas, United States
  • Adverum Clinical Site 127 — Austin, Texas, United States
  • Adverum Clinical Site 243 — 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 185 — San Antonio, 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
  • Adverum Clinical Site 249 — Silverdale, Washington, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record