One-Shot gene therapy could replace frequent eye injections for wet AMD
NCT ID NCT07482176
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This phase 3 study tests a single injection of Ixo-vec gene therapy against standard aflibercept injections in 284 people with wet AMD. The goal is to see if Ixo-vec can maintain or improve vision while reducing the need for repeated eye injections. Participants must be at least 50 years old with active disease in the study eye.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 284 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
79 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Adverum Clinical Site 100
RECRUITINGBeverly Hills, California, 90211, United States
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Adverum Clinical Site 101
RECRUITINGNashville, Tennessee, 37203, United States
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Adverum Clinical Site 107
RECRUITINGConroe, Texas, 77384, United States
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Adverum Clinical Site 109
RECRUITINGBakersfield, California, 93309, United States
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Adverum Clinical Site 110
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Adverum Clinical Site 116
RECRUITINGDenver, Colorado, 80207, United States
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Adverum Clinical Site 120
RECRUITINGSt. Petersburg, Florida, 33711, United States
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Adverum Clinical Site 124
RECRUITINGDeerfield Beach, Florida, 33064, United States
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Adverum Clinical Site 126
RECRUITINGPhoenix, Arizona, 85014, United States
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Adverum Clinical Site 127
RECRUITINGAustin, Texas, 78705, United States
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Adverum Clinical Site 130
RECRUITINGPoway, California, 92064, United States
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Adverum Clinical Site 140
RECRUITINGSacramento, California, 95825, United States
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Adverum Clinical Site 145
RECRUITINGArlington, Texas, 76012, United States
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Adverum Clinical Site 148
RECRUITINGTampa, Florida, 33609, United States
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Adverum Clinical Site 162
RECRUITINGMcAllen, Texas, 78503, United States
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Adverum Clinical Site 165
RECRUITINGWaterford, Connecticut, 06385, United States
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Adverum Clinical Site 168
RECRUITINGMiami Springs, Florida, 33166, United States
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Adverum Clinical Site 169
RECRUITINGFullerton, California, 92835, United States
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Adverum Clinical Site 171
RECRUITINGTeaneck, New Jersey, 07666, United States
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Adverum Clinical Site 172
RECRUITINGEncino, California, 91436, United States
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Adverum Clinical Site 175
RECRUITINGSanta Barbara, California, 93103, United States
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Adverum Clinical Site 176
RECRUITINGFort Lauderdale, Florida, 33308, United States
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Adverum Clinical Site 178
RECRUITINGPhoenix, Arizona, 85020, United States
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Adverum Clinical Site 179
RECRUITINGOak Forest, Illinois, 60452, United States
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Adverum Clinical Site 181
RECRUITINGErie, Pennsylvania, 16505, United States
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Adverum Clinical Site 182
RECRUITINGAugusta, Georgia, 30909, United States
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Adverum Clinical Site 183
RECRUITINGSouth Miami, Florida, 33143, United States
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Adverum Clinical Site 184
RECRUITINGDeerfield Beach, Florida, 33064, United States
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Adverum Clinical Site 185
RECRUITINGSan Antonio, Texas, 78240, United States
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Adverum Clinical Site 189
RECRUITINGWalnut Creek, California, 94598, United States
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Adverum Clinical Site 194
RECRUITINGDallas, Texas, 75231, United States
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Adverum Clinical Site 195
RECRUITINGCarmel, Indiana, 46032, United States
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Adverum Clinical Site 196
RECRUITINGAsheville, North Carolina, 28803, United States
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Adverum Clinical Site 197
RECRUITINGHagerstown, Maryland, 21740, United States
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Adverum Clinical Site 198
RECRUITINGSpringdale, Arkansas, 72764, United States
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Adverum Clinical Site 199
RECRUITINGLynchburg, Virginia, 24502, United States
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Adverum Clinical Site 200
RECRUITINGDenver, Colorado, 800222, United States
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Adverum Clinical Site 201
RECRUITINGCampbell, California, 95008, United States
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Adverum Clinical Site 202
RECRUITINGTorrance, California, 90503, United States
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Adverum Clinical Site 204
RECRUITINGHagerstown, Maryland, 21740, United States
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Adverum Clinical Site 205
RECRUITINGCarmel, Indiana, 46032, United States
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Adverum Clinical Site 206
RECRUITINGPlantation, Florida, 33324, United States
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Adverum Clinical Site 207
RECRUITINGOak Park, Illinois, 60304, United States
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Adverum Clinical Site 209
RECRUITINGWake Forest, North Carolina, 27587, United States
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Adverum Clinical Site 211
RECRUITINGGreensboro, North Carolina, 27401, United States
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Adverum Clinical Site 212
RECRUITINGSacramento, California, 95841, United States
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Adverum Clinical Site 213
RECRUITINGOrlando, Florida, 32806, United States
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Adverum Clinical Site 214
RECRUITINGLakeland, Florida, 33805, United States
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Adverum Clinical Site 215
RECRUITINGRedlands, California, 92374, United States
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Adverum Clinical Site 216
RECRUITINGJackson, Mississippi, 39202, United States
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Adverum Clinical Site 219
RECRUITINGGreensboro, North Carolina, 27401, United States
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Adverum Clinical Site 220
RECRUITINGHickory, North Carolina, 28602, United States
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Adverum Clinical Site 221
RECRUITINGFort Myers, Florida, 33912, United States
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Adverum Clinical Site 222
RECRUITINGLadson, South Carolina, 29456, United States
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Adverum Clinical Site 223
RECRUITINGPhoenix, Arizona, 85020, United States
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Adverum Clinical Site 224
RECRUITINGHuntington Beach, California, 92647, United States
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Adverum Clinical Site 225
RECRUITINGLiverpool, New York, 13088, United States
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Adverum Clinical Site 228
RECRUITINGSchertz, Texas, 78154, United States
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Adverum Clinical Site 229
RECRUITINGScottsdale, Arizona, 85255, United States
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Adverum Clinical Site 231
RECRUITINGThe Woodlands, Texas, 77384, United States
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Adverum Clinical Site 232
RECRUITINGSan Marcos, Texas, 78666, United States
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Adverum Clinical Site 234
RECRUITINGCary, North Carolina, 27511, United States
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Adverum Clinical Site 236
RECRUITINGGainesville, Florida, 32607, United States
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Adverum Clinical Site 237
RECRUITINGTyler, Texas, 75703, United States
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Adverum Clinical Site 238
RECRUITINGWinter Haven, Florida, 33880, United States
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Adverum Clinical Site 239
RECRUITINGPhiladelphia, Pennsylvania, 19102, United States
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Adverum Clinical Site 240
RECRUITINGBloomfield, New Jersey, 07003, United States
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Adverum Clinical Site 241
RECRUITINGBluffton, South Carolina, 29910, United States
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Adverum Clinical Site 242
RECRUITINGSun City, Arizona, 85351, United States
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Adverum Clinical Site 243
RECRUITINGAustin, Texas, 78750, United States
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Adverum Clinical Site 244
RECRUITINGRochester, New York, 14620, United States
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Adverum Clinical Site 245
RECRUITINGMesa, Arizona, 85206, United States
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Adverum Clinical Site 246
RECRUITINGChicago, Illinois, 60616, United States
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Adverum Clinical Site 247
RECRUITINGCleveland, Ohio, 44130, United States
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Adverum Clinical Site 248
RECRUITINGBeachwood, Ohio, 44122-5846, United States
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Adverum Clinical Site 249
RECRUITINGSilverdale, Washington, 98383, United States
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Adverum Clinical Site 252
RECRUITINGPortland, Oregon, 97225, United States
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Adverum Clinical Site 253
RECRUITINGCarmel, Indiana, 46032, United States
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Adverum Clinical Site 254
RECRUITINGEdmond, Oklahoma, 73013, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One eye injection, four targets: GenSci148 tested against retinal swelling
- Can a new eye injection beat the standard for wet AMD?
- Can a One-Time gene therapy tame wet AMD for years?
- Laser zap before eye injection could cut needle count for wet AMD
- New eye injection shows promise for wet AMD in everyday practice
- New syringe could simplify High-Dose eye treatment