NCT07482176From ClinicalTrials.govRecruiting

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

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)

Neovascular Age-Related Macular Degeneration (nAMD)
Wet AMD

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Adverum Biotechnologies, Inc.
Enrolment target: 534
Started: 16 March 2026
Main results due: 15 November 2027
Study sites: 79
Registry updated: 24 September 2026

Can you take part?

Aged 50 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(79)

Adverum Clinical Site 245
Mesa, Arizona, United States
Recruiting
Adverum Clinical Site 126
Phoenix, Arizona, United States
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Adverum Clinical Site 178
Phoenix, Arizona, United States
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Adverum Clinical Site 223
Phoenix, Arizona, United States
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Adverum Clinical Site 229
Scottsdale, Arizona, United States
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Adverum Clinical Site 242
Sun City, Arizona, United States
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Adverum Clinical Site 198
Springdale, Arkansas, United States
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Adverum Clinical Site 109
Bakersfield, California, United States
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Adverum Clinical Site 100
Beverly Hills, California, United States
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Adverum Clinical Site 201
Campbell, California, United States
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Adverum Clinical Site 172
Encino, California, United States
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Adverum Clinical Site 169
Fullerton, California, United States
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Adverum Clinical Site 224
Huntington Beach, California, United States
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Adverum Clinical Site 130
Poway, California, United States
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Adverum Clinical Site 215
Redlands, California, United States
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Adverum Clinical Site 140
Sacramento, California, United States
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Adverum Clinical Site 212
Sacramento, California, United States
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Adverum Clinical Site 175
Santa Barbara, California, United States
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Adverum Clinical Site 202
Torrance, California, United States
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Adverum Clinical Site 189
Walnut Creek, California, United States
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Adverum Clinical Site 200
Denver, Colorado, United States
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Adverum Clinical Site 116
Denver, Colorado, United States
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Adverum Clinical Site 165
Waterford, Connecticut, United States
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Adverum Clinical Site 124
Deerfield Beach, Florida, United States
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Adverum Clinical Site 184
Deerfield Beach, Florida, United States
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Adverum Clinical Site 176
Fort Lauderdale, Florida, United States
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Adverum Clinical Site 221
Fort Myers, Florida, United States
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Adverum Clinical Site 236
Gainesville, Florida, United States
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Adverum Clinical Site 214
Lakeland, Florida, United States
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Adverum Clinical Site 168
Miami Springs, Florida, United States
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Adverum Clinical Site 213
Orlando, Florida, United States
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Adverum Clinical Site 206
Plantation, Florida, United States
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Adverum Clinical Site 183
South Miami, Florida, United States
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Adverum Clinical Site 120
St. Petersburg, Florida, United States
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Adverum Clinical Site 148
Tampa, Florida, United States
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Adverum Clinical Site 238
Winter Haven, Florida, United States
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Adverum Clinical Site 182
Augusta, Georgia, United States
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Adverum Clinical Site 246
Chicago, Illinois, United States
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Adverum Clinical Site 179
Oak Forest, Illinois, United States
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Adverum Clinical Site 207
Oak Park, Illinois, United States
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Adverum Clinical Site 195
Carmel, Indiana, United States
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Adverum Clinical Site 205
Carmel, Indiana, United States
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Adverum Clinical Site 253
Carmel, Indiana, United States
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Adverum Clinical Site 197
Hagerstown, Maryland, United States
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Adverum Clinical Site 204
Hagerstown, Maryland, United States
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Adverum Clinical Site 216
Jackson, Mississippi, United States
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Adverum Clinical Site 240
Bloomfield, New Jersey, United States
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Adverum Clinical Site 171
Teaneck, New Jersey, United States
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Adverum Clinical Site 225
Liverpool, New York, United States
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Adverum Clinical Site 244
Rochester, New York, United States
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Adverum Clinical Site 196
Asheville, North Carolina, United States
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Adverum Clinical Site 234
Cary, North Carolina, United States
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Adverum Clinical Site 211
Greensboro, North Carolina, United States
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Adverum Clinical Site 219
Greensboro, North Carolina, United States
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Adverum Clinical Site 220
Hickory, North Carolina, United States
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Adverum Clinical Site 209
Wake Forest, North Carolina, United States
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Adverum Clinical Site 248
Beachwood, Ohio, United States
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Adverum Clinical Site 247
Cleveland, Ohio, United States
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Adverum Clinical Site 254
Edmond, Oklahoma, United States
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Adverum Clinical Site 252
Portland, Oregon, United States
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Showing 60 of 79 sites — filter to narrow it down. 79 of the 79 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07482176. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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