Actively Recruiting
A Multi-center, Randomized, Double-masked, Active-comparator-controlled Study to Evaluate the Efficacy and Safety of Ixoberogene Soroparvovec (Ixo-vec) in Neovascular Age-related Macular Degeneration
Led by Adverum Biotechnologies, Inc. · Updated on 2026-05-20
284
Participants Needed
46
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a gene therapy called Ixoberogene Soroparvovec (Ixo-vec) compared to a standard treatment called aflibercept in people with neovascular (wet) age-related macular degeneration (nAMD). This Phase 3 study involves participants who have not been treated before or have prior treatment experience. The study focuses on measuring changes in best corrected visual acuity (BCVA) at one year after treatment to see how well Ixo-vec works compared to aflibercept. Participants will receive either a single intravitreal injection of Ixo-vec or a series of injections of aflibercept. All participants get three monthly aflibercept doses as a loading phase, followed by either a single Ixo-vec injection at Week 1 with sham injections every 8 weeks, or sham injection at Week 1 with aflibercept injections every 8 weeks. This design allows comparison between the gene therapy and the active drug over a 56-week period. Throughout the study, participants will have regular eye exams to measure visual acuity and retinal thickness, and researchers will monitor safety and treatment effects. Assessments include visual function questionnaires and imaging to track changes in retinal anatomy. The study lasts more than a year, with key outcomes measured at Weeks 52 and 56. Safety, tolerability, and vision changes will be carefully reviewed during this time.
CONDITIONS
Brief Title
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent and comply with study visits
- Male or female diagnosed with choroidal neovascularization secondary to neovascular age-related macular degeneration in the study eye
- At least 50 years old at screening
- Best corrected visual acuity letter score between 35 and 78 in the study eye
- Showed meaningful anatomic response to anti-VEGF therapy during screening
- Able to reliably use eye drops as required by the study protocol
You will not qualify if you...
- Medical conditions that contraindicate use of Ixo-vec or affect study participation
- Previous gene therapy
- Treatment with investigational non-gene therapy or device in the study eye within 3 months prior to screening
- Pregnant or breastfeeding females or those planning pregnancy
- History of myocardial infarction or stroke within 6 months before Week 1
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Ongoing bleeding disorders (aspirin or anticoagulants allowed)
- Use of systemic immunosuppressive drugs within 90 days prior to screening
- Poorly controlled diabetes or HbA1c ≥ 8.0%
- Active ocular or periocular infection in the study eye
- Eye surgeries or laser treatments in the study eye within specified timeframes
- History of retinal detachment or retinal pigment epithelium tear in the study eye
- Uncontrolled ocular hypertension or glaucoma requiring multiple medications or prior glaucoma surgeries
- History of eye inflammation, uveitis, or herpes virus infections affecting either eye
- Previous treatment with complement inhibitors for geographic atrophy in the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 56 weeks
Participants receive intravitreal injections including 3 monthly loading doses of aflibercept 2 mg IVT, a single IVT injection of Ixo-vec or sham injection at Week 1, followed by injections every 8 weeks for up to 56 weeks.
Multiple visits including monthly visits for the first 3 months and visits every 8 weeks thereafter
Duration - Up to Week 56 post-treatment
Participants are monitored for safety, tolerability, and efficacy outcomes through Week 56 after treatment.
Visits coincide with treatment visits and additional assessments as needed
Trial Site Locations
Total: 46 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 201
Campbell, California, United States, 95008
Actively Recruiting
9
Adverum Clinical Site 172
Encino, California, United States, 91436
Actively Recruiting
10
Adverum Clinical Site 169
Fullerton, California, United States, 92835
Actively Recruiting
11
Adverum Clinical Site 224
Huntington Beach, California, United States, 92647
Actively Recruiting
12
Adverum Clinical Site 215
Redlands, California, United States, 92374
Actively Recruiting
13
Adverum Clinical Site 140
Sacramento, California, United States, 95825
Actively Recruiting
14
Adverum Clinical Site 212
Sacramento, California, United States, 95841
Actively Recruiting
15
Adverum Clinical Site 202
Torrance, California, United States, 90503
Actively Recruiting
16
Adverum Clinical Site 189
Walnut Creek, California, United States, 94598
Actively Recruiting
17
Adverum Clinical Site 116
Denver, Colorado, United States, 80207
Actively Recruiting
18
Adverum Clinical Site 165
Waterford, Connecticut, United States, 06385
Actively Recruiting
19
Adverum Clinical Site 124
Deerfield Beach, Florida, United States, 33064
Actively Recruiting
20
Adverum Clinical Site 184
Deerfield Beach, Florida, United States, 33064
Actively Recruiting
21
Adverum Clinical Site 176
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
22
Adverum Clinical Site 221
Fort Myers, Florida, United States, 33912
Actively Recruiting
23
Adverum Clinical Site 214
Lakeland, Florida, United States, 33805
Actively Recruiting
24
Adverum Clinical Site 213
Orlando, Florida, United States, 32806
Actively Recruiting
25
Adverum Clinical Site 183
South Miami, Florida, United States, 33143
Actively Recruiting
26
Adverum Clinical Site 182
Augusta, Georgia, United States, 30909
Actively Recruiting
27
Adverum Clinical Site 195
Carmel, Indiana, United States, 46032
Actively Recruiting
28
Adverum Clinical Site 204
Hagerstown, Maryland, United States, 21740
Actively Recruiting
29
Adverum Clinical Site 216
Jackson, Mississippi, United States, 39202
Actively Recruiting
30
Adverum Clinical Site 225
Liverpool, New York, United States, 13088
Actively Recruiting
31
Adverum Clinical Site 196
Asheville, North Carolina, United States, 28803
Actively Recruiting
32
Adverum Clinical Site 211
Greensboro, North Carolina, United States, 27401
Actively Recruiting
33
Adverum Clinical Site 219
Greensboro, North Carolina, United States, 27401
Actively Recruiting
34
Adverum Clinical Site 220
Hickory, North Carolina, United States, 28602
Actively Recruiting
35
Adverum Clinical Site 209
Wake Forest, North Carolina, United States, 27587
Actively Recruiting
36
Adverum Clinical Site 241
Bluffton, South Carolina, United States, 29910
Actively Recruiting
37
Adverum Clinical Site 222
Ladson, South Carolina, United States, 29456
Actively Recruiting
38
Adverum Clinical Site 127
Austin, Texas, United States, 78705
Actively Recruiting
39
Adverum Clinical Site 107
Conroe, Texas, United States, 77384
Actively Recruiting
40
Adverum Clinical Site 194
Dallas, Texas, United States, 75231
Actively Recruiting
41
Adverum Clinical Site 162
McAllen, Texas, United States, 78503
Actively Recruiting
42
Adverum Clinical Site 232
San Marcos, Texas, United States, 78666
Actively Recruiting
43
Adverum Clinical Site 228
Schertz, Texas, United States, 78154
Actively Recruiting
44
Adverum Clinical Site 231
The Woodlands, Texas, United States, 77384
Actively Recruiting
45
Adverum Clinical Site 237
Tyler, Texas, United States, 75703
Actively Recruiting
46
Adverum Clinical Site 199
Lynchburg, Virginia, United States, 24502
Actively Recruiting
Research Team
A
Adverum Study 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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