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Clinical Trials in the USA / NCT07482176
Recruiting Phase 3

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

NCT07482176 · tracked via the Priya Life Science USA tracker
Sponsor
Adverum Biotechnologies, Inc.
Phase
Phase 3
Started
2026-03-16
Last updated
2026-07-15

Condition(s) studied

Neovascular Age-Related Macular Degeneration (nAMD)Wet AMD

Investigational drug(s) / intervention(s)

Ixo-vecAflibercept

Ixo-vec: Ixo-vec will be administered intravitreally.

Aflibercept: Aflibercept will be administered intravitreally.

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (79)

FacilityCityRegionStatus
Adverum Clinical Site 245 Mesa Arizona Recruiting
Adverum Clinical Site 126 Phoenix Arizona Recruiting
Adverum Clinical Site 178 Phoenix Arizona Recruiting
Adverum Clinical Site 223 Phoenix Arizona Recruiting
Adverum Clinical Site 229 Scottsdale Arizona Recruiting
Adverum Clinical Site 242 Sun City Arizona Recruiting
Adverum Clinical Site 198 Springdale Arkansas Recruiting
Adverum Clinical Site 109 Bakersfield California Recruiting
Adverum Clinical Site 100 Beverly Hills California Recruiting
Adverum Clinical Site 201 Campbell California Recruiting
Adverum Clinical Site 172 Encino California Recruiting
Adverum Clinical Site 169 Fullerton California Recruiting
Adverum Clinical Site 224 Huntington Beach California Recruiting
Adverum Clinical Site 130 Poway California Recruiting
Adverum Clinical Site 215 Redlands California Recruiting
Adverum Clinical Site 140 Sacramento California Recruiting
Adverum Clinical Site 212 Sacramento California Recruiting
Adverum Clinical Site 175 Santa Barbara California Recruiting
Adverum Clinical Site 202 Torrance California Recruiting
Adverum Clinical Site 189 Walnut Creek California Recruiting
Adverum Clinical Site 200 Denver Colorado Recruiting
Adverum Clinical Site 116 Denver Colorado Recruiting
Adverum Clinical Site 165 Waterford Connecticut Recruiting
Adverum Clinical Site 124 Deerfield Beach Florida Recruiting
Adverum Clinical Site 184 Deerfield Beach Florida Recruiting
Adverum Clinical Site 176 Fort Lauderdale Florida Recruiting
Adverum Clinical Site 221 Fort Myers Florida Recruiting
Adverum Clinical Site 236 Gainesville Florida Recruiting
Adverum Clinical Site 214 Lakeland Florida Recruiting
Adverum Clinical Site 168 Miami Springs Florida Recruiting
Adverum Clinical Site 213 Orlando Florida Recruiting
Adverum Clinical Site 206 Plantation Florida Recruiting
Adverum Clinical Site 183 South Miami Florida Recruiting
Adverum Clinical Site 120 St. Petersburg Florida Recruiting
Adverum Clinical Site 148 Tampa Florida Recruiting
Adverum Clinical Site 238 Winter Haven Florida Recruiting
Adverum Clinical Site 182 Augusta Georgia Recruiting
Adverum Clinical Site 246 Chicago Illinois Recruiting
Adverum Clinical Site 179 Oak Forest Illinois Recruiting
Adverum Clinical Site 207 Oak Park Illinois Recruiting

+ 39 more sites — see the full list on the official registry below.

More Adverum Biotechnologies, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07482176 on ClinicalTrials.gov ↗ ← All trials in the USA