Actively Recruiting

Phase 3
Age: 50Years +
All Genders
NCT07482176

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

Led by Adverum Biotechnologies, Inc. · Updated on 2026-04-29

284

Participants Needed

36

Research Sites

292 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide informed consent and comply with study requirements and visits.
  • Male or female diagnosed with choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration in the study eye, with active disease at screening.
  • At least 50 years old at screening.
  • Best corrected visual acuity (BCVA) letter score between 35 and 78 (approximate Snellen equivalent 20/200 to 20/32) in the study eye at screening.
  • Demonstrated meaningful anatomic response to prior anti-VEGF therapy during screening.
  • Able to reliably use eye drops as required by the study protocol.
Not Eligible

You will not qualify if you...

  • History of medical conditions that contraindicate Ixo-vec use, interfere with study participation, or increase treatment risk, including severe COVID-19 if judged relevant.
  • Received prior gene therapy.
  • Received investigational medicinal product or medical device in the study eye within 3 months or 5 half-lives before dosing.
  • Female participants who are pregnant, breastfeeding, or planning pregnancy.
  • History of myocardial infarction or stroke within 6 months before Week 1.
  • Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg) during screening.
  • Ongoing bleeding disorders (aspirin or some anticoagulants allowed).
  • Use of systemic immunosuppressive drugs within 90 days before screening, except short courses of corticosteroids or certain steroid forms.
  • Poorly controlled diabetes with HbA1c ≥ 8.0% during screening.
  • Active ocular or periocular infection in the study eye at screening.
  • History of intraocular or refractive surgery within 5 months prior to Week 1.
  • Previous penetrating keratoplasty or vitrectomy in the study eye.
  • Previous panretinal photocoagulation or certain other ocular surgeries or laser treatments for AMD.
  • History or evidence of retinal detachment or retinal pigment epithelium rip/tear in the study eye.
  • Uncontrolled ocular hypertension or glaucoma, use of 2 or more IOP-lowering medications, or history of specific glaucoma surgeries in the study eye.
  • History of IOP elevation related to topical steroid use in either eye.
  • History of uveitis or inflammation (grade trace or above) except mild postoperative inflammation resolved in either eye.
  • History of treatment with complement inhibitors for geographic atrophy in the study eye.
  • Known history of ocular herpes simplex, varicella-zoster, or cytomegalovirus infections including viral uveitis, retinitis, or keratitis in either eye.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 36 locations

1

Adverum Clinical Site 126

Phoenix, Arizona, United States, 85014

Actively Recruiting

2

Adverum Clinical Site 178

Phoenix, Arizona, United States, 85020

Actively Recruiting

3

Adverum Clinical Site 223

Phoenix, Arizona, United States, 85020

Actively Recruiting

4

Adverum Clinical Site 229

Scottsdale, Arizona, United States, 85255

Actively Recruiting

5

Adverum Clinical Site 198

Springdale, Arkansas, United States, 72764

Actively Recruiting

6

Adverum Clinical Site 109

Bakersfield, California, United States, 93309

Actively Recruiting

7

Adverum Clinical Site 100

Beverly Hills, California, United States, 90211

Actively Recruiting

8

Adverum Clinical Site 172

Encino, California, United States, 91436

Actively Recruiting

9

Adverum Clinical Site 169

Fullerton, California, United States, 92835

Actively Recruiting

10

Adverum Clinical Site 224

Huntington Beach, California, United States, 92647

Actively Recruiting

11

Adverum Clinical Site 215

Redlands, California, United States, 92374

Actively Recruiting

12

Adverum Clinical Site 140

Sacramento, California, United States, 95825

Actively Recruiting

13

Adverum Clinical Site 202

Torrance, California, United States, 90503

Actively Recruiting

14

Adverum Clinical Site 116

Denver, Colorado, United States, 80207

Actively Recruiting

15

Adverum Clinical Site 165

Waterford, Connecticut, United States, 06385

Actively Recruiting

16

Adverum Clinical Site 184

Deerfield Beach, Florida, United States, 33064

Actively Recruiting

17

Adverum Clinical Site 176

Fort Lauderdale, Florida, United States, 33308

Actively Recruiting

18

Adverum Clinical Site 221

Fort Myers, Florida, United States, 33912

Actively Recruiting

19

Adverum Clinical Site 183

South Miami, Florida, United States, 33143

Actively Recruiting

20

Adverum Clinical Site 182

Augusta, Georgia, United States, 30909

Actively Recruiting

21

Adverum Clinical Site 204

Hagerstown, Maryland, United States, 21740

Actively Recruiting

22

Adverum Clinical Site 216

Jackson, Mississippi, United States, 39202

Actively Recruiting

23

Adverum Clinical Site 225

Liverpool, New York, United States, 13088

Actively Recruiting

24

Adverum Clinical Site 196

Asheville, North Carolina, United States, 28803

Actively Recruiting

25

Adverum Clinical Site 211

Greensboro, North Carolina, United States, 27401

Actively Recruiting

26

Adverum Clinical Site 219

Greensboro, North Carolina, United States, 27401

Actively Recruiting

27

Adverum Clinical Site 220

Hickory, North Carolina, United States, 28602

Actively Recruiting

28

Adverum Clinical Site 209

Wake Forest, North Carolina, United States, 27587

Actively Recruiting

29

Adverum Clinical Site 127

Austin, Texas, United States, 78705

Actively Recruiting

30

Adverum Clinical Site 194

Dallas, Texas, United States, 75231

Actively Recruiting

31

Adverum Clinical Site 162

McAllen, Texas, United States, 78503

Actively Recruiting

32

Adverum Clinical Site 232

San Marcos, Texas, United States, 78666

Actively Recruiting

33

Adverum Clinical Site 228

Schertz, Texas, United States, 78154

Actively Recruiting

34

Adverum Clinical Site 231

The Woodlands, Texas, United States, 77384

Actively Recruiting

35

Adverum Clinical Site 237

Tyler, Texas, United States, 75703

Actively Recruiting

36

Adverum Clinical Site 199

Lynchburg, Virginia, United States, 24502

Actively Recruiting

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Research Team

A

Adverum Study Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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