Actively Recruiting
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration
Led by Adverum Biotechnologies, Inc. · Updated on 2025-11-18
284
Participants Needed
79
Research Sites
299 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 an 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 at an average of 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
Who Can Participate
Eligibility Criteria
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 secondary to neovascular age-related macular degeneration (nAMD) in the study eye, showing disease activity at screening
- At least 50 years old at screening
- Best corrected visual acuity (BCVA) letter score between 35 and 78 in the study eye at screening (approximate Snellen equivalent of 20/200 to 20/32)
- Demonstrated a meaningful anatomical 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...
- History of medical conditions that contraindicate Ixo-vec use or may affect study participation or results, including severe COVID-19 complications as judged by the investigator
- Prior gene therapy treatment
- Treatment with any non-gene therapy investigational drug or device in the study eye within 3 months before screening or 5 half-lives of the drug prior to dosing, whichever is longer
- Female participants who are pregnant, breastfeeding, or intend to become pregnant or breastfeed
- History or evidence of recent myocardial infarction or stroke within 6 months before Week 1
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg) during screening
- History of ongoing bleeding disorders (aspirin or anticoagulants allowed)
- Use of systemic immunosuppressive drugs within 90 days prior to screening (short courses of corticosteroids and local steroid use permitted)
- Poorly controlled diabetes with HbA1c ≥ 8.0% during screening
- Active ocular or periocular infection in the study eye at screening
- History or evidence of recent intraocular or refractive surgery within 5 months prior to Week 1 in the study eye
- Previous penetrating keratoplasty, vitrectomy, panretinal photocoagulation, submacular surgery, or laser treatment for age-related macular degeneration in the study eye
- History or evidence of retinal detachment or retinal pigment epithelium tear in the study eye
- Uncontrolled ocular hypertension or glaucoma in the study eye, current use of two or more IOP-lowering medications, or history of specific glaucoma surgeries
- History of intraocular pressure elevation related to topical steroid use in either eye
- History of uveitis or inflammation (greater than mild postoperative inflammation) in either eye
- Prior treatment with complement inhibitors for geographic atrophy in the study eye
- Known history of ocular herpes simplex virus, varicella-zoster virus, or cytomegalovirus infections including viral uveitis, retinitis, or keratitis in either eye
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 79 locations
1
Adverum Clinical Site 223
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
Adverum Clinical Site 178
Phoenix, Arizona, United States, 85021
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3
Adverum Clinical Site 126
Phoenix, Arizona, United States, 85053
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4
Adverum Clinical Site 229
Scottsdale, Arizona, United States, 85255
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5
Adverum Clinical Site 159
Tucson, Arizona, United States, 85704
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6
Adverum Clinical Site 198
Springdale, Arkansas, United States, 72764
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7
Adverum Clinical Site 109
Bakersfield, California, United States, 93309
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8
Adverum Clinical Site 100
Beverly Hills, California, United States, 90211
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9
Adverum Clinical Site 201
Campbell, California, United States, 95008
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10
Adverum Clinical Site 172
Encino, California, United States, 91436
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11
Adverum Clinical Site 169
Fullerton, California, United States, 92835
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12
Adverum Clinical Site 224
Huntington Beach, California, United States, 92647
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13
Adverum Clinical Site 215
Redlands, California, United States, 92374
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14
Adverum Clinical Site 164
Riverside, California, United States, 92505
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15
Adverum Clinical Site 140
Sacramento, California, United States, 95825
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16
Adverum Clinical Site 212
Sacramento, California, United States, 95841
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17
Adverum Clinical Site 175
Santa Barbara, California, United States, 93103
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18
Adverum Clinical Site 202
Torrance, California, United States, 90503
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19
Adverum Clinical Site 189
Walnut Creek, California, United States, 94598
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20
Adverum Clinical Site 200
Denver, Colorado, United States, 80222
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21
Adverum Clinical Site 116
Lakewood, Colorado, United States, 80228
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22
Adverum Clinical Site 165
Waterford, Connecticut, United States, 06385
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23
Adverum Clinical Site 184
Deerfield Beach, Florida, United States, 33064
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24
Adverum Clinical Site 176
Fort Lauderdale, Florida, United States, 33308
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25
Adverum Clinical Site 221
Fort Myers, Florida, United States, 33912
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26
Adverum Clinical Site 236
Gainesville, Florida, United States, 32605
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27
Adverum Clinical Site 168
Jacksonville, Florida, United States, 32216
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28
Adverum Clinical Site 214
Lakeland, Florida, United States, 33805
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29
Adverum Clinical Site 213
Orlando, Florida, United States, 32806
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30
Adverum Clinical Site 230
Pensacola, Florida, United States, 32503
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31
Adverum Clinical Site 124
Pompano Beach, Florida, United States, 33064
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32
Adverum Clinical Site 183
South Miami, Florida, United States, 33143
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33
Adverum Clinical Site 120
St. Petersburg, Florida, United States, 33711
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34
Adverum Clinical Site 193
Tampa, Florida, United States, 33617
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35
Adverum Clinical Site 182
Augusta, Georgia, United States, 30909
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36
Adverum Clinical Site 149
‘Aiea, Hawaii, United States, 96701
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37
Adverum Clinical Site 179
Oak Forest, Illinois, United States, 60452
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38
Adverum Clinical Site 207
Oak Park, Illinois, United States, 60304
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39
Adverum Clinical Site 195
Carmel, Indiana, United States, 46032
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40
Adverum Clinical Site 205
Carmel, Indiana, United States, 46032
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41
Adverum Clinical Site 197
Hagerstown, Maryland, United States, 21740
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42
Adverum Clinical Site 204
Hagerstown, Maryland, United States, 21740
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43
Adverum Clinical Site 167
Detroit, Michigan, United States, 48201
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44
Adverum Clinical Site 216
Madison, Mississippi, United States, 39110
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45
Adverum Clinical Site 163
Southaven, Mississippi, United States, 38671
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46
Adverum Clinical Site 190
St Louis, Missouri, United States, 63128
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47
Adverum Clinical Site 171
Teaneck, New Jersey, United States, 07666
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48
Adverum Clinical Site 225
Liverpool, New York, United States, 13088
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49
Adverum Clinical Site 196
Asheville, North Carolina, United States, 28803
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50
Adverum Clinical Site 234
Cary, North Carolina, United States, 27511
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51
Adverum Clinical Site 186
Durham, North Carolina, United States, 27705
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52
Adverum Clinical Site 211
Greensboro, North Carolina, United States, 27401
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53
Adverum Clinical Site 220
Hickory, North Carolina, United States, 28602
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54
Adverum Clinical Site 209
Wake Forest, North Carolina, United States, 27587
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55
Adverum Clinical Site 219
Winston-Salem, North Carolina, United States, 27103
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56
Adverum Clinical Site 181
Erie, Pennsylvania, United States, 16507
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57
Adverum Clinical Site 110
Philadelphia, Pennsylvania, United States, 19107
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58
Adverum Clinical Site 208
Charleston, South Carolina, United States, 29414
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59
Adverum Clinical Site 222
Ladson, South Carolina, United States, 29456
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60
Adverum Clinical Site 122
West Columbia, South Carolina, United States, 29169
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61
Adverum Clinical Site 144
Rapid City, South Dakota, United States, 57701
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62
Adverum Clinical Site 123
Abilene, Texas, United States, 79606
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63
Adverum Clinical Site 127
Austin, Texas, United States, 78705
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64
Adverum Clinical Site 108
Bellaire, Texas, United States, 77401
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65
Adverum Clinical Site 227
Burleson, Texas, United States, 76028
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66
Adverum Clinical Site 194
Dallas, Texas, United States, 75231
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67
Adverum Clinical Site 188
Houston, Texas, United States, 77030
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68
Adverum Clinical Site 218
Katy, Texas, United States, 77494
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69
Adverum Clinical Site 162
McAllen, Texas, United States, 78503
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70
Adverum Clinical Site 151
San Antonio, Texas, United States, 78240
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71
Adverum Clinical Site 185
San Antonio, Texas, United States, 78240
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72
Adverum Clinical Site 232
San Marcos, Texas, United States, 78666
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73
Adverum Clinical Site 228
Schertz, Texas, United States, 78154
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74
Adverum Clinical Site 107
The Woodlands, Texas, United States, 77384
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75
Adverum Clinical Site 231
The Woodlands, Texas, United States, 77384
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76
Adverum Clinical Site 199
Lynchburg, Virginia, United States, 24502
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77
Adverum Clinical Site 131
Spokane, Washington, United States, 99204
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78
Adverum Clinical Site 152
Morgantown, West Virginia, United States, 26506
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79
Adverum Clinical Site 187
Wausau, Wisconsin, United States, 54403
Actively Recruiting
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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