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One-Shot gene therapy could replace frequent eye injections for wet AMD

NCT ID NCT07482176

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 284 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    79 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Adverum Clinical Site 100

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Adverum Clinical Site 101

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Adverum Clinical Site 107

    RECRUITING

    Conroe, Texas, 77384, United States

  • Adverum Clinical Site 109

    RECRUITING

    Bakersfield, California, 93309, United States

  • Adverum Clinical Site 110

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Adverum Clinical Site 116

    RECRUITING

    Denver, Colorado, 80207, United States

  • Adverum Clinical Site 120

    RECRUITING

    St. Petersburg, Florida, 33711, United States

  • Adverum Clinical Site 124

    RECRUITING

    Deerfield Beach, Florida, 33064, United States

  • Adverum Clinical Site 126

    RECRUITING

    Phoenix, Arizona, 85014, United States

  • Adverum Clinical Site 127

    RECRUITING

    Austin, Texas, 78705, United States

  • Adverum Clinical Site 130

    RECRUITING

    Poway, California, 92064, United States

  • Adverum Clinical Site 140

    RECRUITING

    Sacramento, California, 95825, United States

  • Adverum Clinical Site 145

    RECRUITING

    Arlington, Texas, 76012, United States

  • Adverum Clinical Site 148

    RECRUITING

    Tampa, Florida, 33609, United States

  • Adverum Clinical Site 162

    RECRUITING

    McAllen, Texas, 78503, United States

  • Adverum Clinical Site 165

    RECRUITING

    Waterford, Connecticut, 06385, United States

  • Adverum Clinical Site 168

    RECRUITING

    Miami Springs, Florida, 33166, United States

  • Adverum Clinical Site 169

    RECRUITING

    Fullerton, California, 92835, United States

  • Adverum Clinical Site 171

    RECRUITING

    Teaneck, New Jersey, 07666, United States

  • Adverum Clinical Site 172

    RECRUITING

    Encino, California, 91436, United States

  • Adverum Clinical Site 175

    RECRUITING

    Santa Barbara, California, 93103, United States

  • Adverum Clinical Site 176

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Adverum Clinical Site 178

    RECRUITING

    Phoenix, Arizona, 85020, United States

  • Adverum Clinical Site 179

    RECRUITING

    Oak Forest, Illinois, 60452, United States

  • Adverum Clinical Site 181

    RECRUITING

    Erie, Pennsylvania, 16505, United States

  • Adverum Clinical Site 182

    RECRUITING

    Augusta, Georgia, 30909, United States

  • Adverum Clinical Site 183

    RECRUITING

    South Miami, Florida, 33143, United States

  • Adverum Clinical Site 184

    RECRUITING

    Deerfield Beach, Florida, 33064, United States

  • Adverum Clinical Site 185

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Adverum Clinical Site 189

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Adverum Clinical Site 194

    RECRUITING

    Dallas, Texas, 75231, United States

  • Adverum Clinical Site 195

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Adverum Clinical Site 196

    RECRUITING

    Asheville, North Carolina, 28803, United States

  • Adverum Clinical Site 197

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Adverum Clinical Site 198

    RECRUITING

    Springdale, Arkansas, 72764, United States

  • Adverum Clinical Site 199

    RECRUITING

    Lynchburg, Virginia, 24502, United States

  • Adverum Clinical Site 200

    RECRUITING

    Denver, Colorado, 800222, United States

  • Adverum Clinical Site 201

    RECRUITING

    Campbell, California, 95008, United States

  • Adverum Clinical Site 202

    RECRUITING

    Torrance, California, 90503, United States

  • Adverum Clinical Site 204

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Adverum Clinical Site 205

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Adverum Clinical Site 206

    RECRUITING

    Plantation, Florida, 33324, United States

  • Adverum Clinical Site 207

    RECRUITING

    Oak Park, Illinois, 60304, United States

  • Adverum Clinical Site 209

    RECRUITING

    Wake Forest, North Carolina, 27587, United States

  • Adverum Clinical Site 211

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Adverum Clinical Site 212

    RECRUITING

    Sacramento, California, 95841, United States

  • Adverum Clinical Site 213

    RECRUITING

    Orlando, Florida, 32806, United States

  • Adverum Clinical Site 214

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Adverum Clinical Site 215

    RECRUITING

    Redlands, California, 92374, United States

  • Adverum Clinical Site 216

    RECRUITING

    Jackson, Mississippi, 39202, United States

  • Adverum Clinical Site 219

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Adverum Clinical Site 220

    RECRUITING

    Hickory, North Carolina, 28602, United States

  • Adverum Clinical Site 221

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • Adverum Clinical Site 222

    RECRUITING

    Ladson, South Carolina, 29456, United States

  • Adverum Clinical Site 223

    RECRUITING

    Phoenix, Arizona, 85020, United States

  • Adverum Clinical Site 224

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Adverum Clinical Site 225

    RECRUITING

    Liverpool, New York, 13088, United States

  • Adverum Clinical Site 228

    RECRUITING

    Schertz, Texas, 78154, United States

  • Adverum Clinical Site 229

    RECRUITING

    Scottsdale, Arizona, 85255, United States

  • Adverum Clinical Site 231

    RECRUITING

    The Woodlands, Texas, 77384, United States

  • Adverum Clinical Site 232

    RECRUITING

    San Marcos, Texas, 78666, United States

  • Adverum Clinical Site 234

    RECRUITING

    Cary, North Carolina, 27511, United States

  • Adverum Clinical Site 236

    RECRUITING

    Gainesville, Florida, 32607, United States

  • Adverum Clinical Site 237

    RECRUITING

    Tyler, Texas, 75703, United States

  • Adverum Clinical Site 238

    RECRUITING

    Winter Haven, Florida, 33880, United States

  • Adverum Clinical Site 239

    RECRUITING

    Philadelphia, Pennsylvania, 19102, United States

  • Adverum Clinical Site 240

    RECRUITING

    Bloomfield, New Jersey, 07003, United States

  • Adverum Clinical Site 241

    RECRUITING

    Bluffton, South Carolina, 29910, United States

  • Adverum Clinical Site 242

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Adverum Clinical Site 243

    RECRUITING

    Austin, Texas, 78750, United States

  • Adverum Clinical Site 244

    RECRUITING

    Rochester, New York, 14620, United States

  • Adverum Clinical Site 245

    RECRUITING

    Mesa, Arizona, 85206, United States

  • Adverum Clinical Site 246

    RECRUITING

    Chicago, Illinois, 60616, United States

  • Adverum Clinical Site 247

    RECRUITING

    Cleveland, Ohio, 44130, United States

  • Adverum Clinical Site 248

    RECRUITING

    Beachwood, Ohio, 44122-5846, United States

  • Adverum Clinical Site 249

    RECRUITING

    Silverdale, Washington, 98383, United States

  • Adverum Clinical Site 252

    RECRUITING

    Portland, Oregon, 97225, United States

  • Adverum Clinical Site 253

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Adverum Clinical Site 254

    RECRUITING

    Edmond, Oklahoma, 73013, United States

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