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Gene therapy shot could end monthly eye injections for wet AMD

NCT ID NCT06856577

Disease control Sponsor: Adverum Biotechnologies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a single injection of Ixo-vec gene therapy in 311 people with wet age-related macular degeneration (AMD). The goal is to see if it can maintain or improve vision as well as standard aflibercept injections, but with fewer follow-up treatments. Participants receive either Ixo-vec or aflibercept, and their vision is tracked over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ixoberogene soroparvovec (Ixo-vec) gene therapy
What this could lead to
If it works, this could offer a one-time treatment for wet AMD, reducing or eliminating the need for regular eye injections.
What could go wrong
This is still an early Phase 3 trial with 311 participants. The gene therapy may not improve vision as hoped, and there are risks from the injection itself, such as inflammation or infection.
Why investors are watching

Adverum Biotechnologies is running a Phase 3 trial of Ixo-vec, a one-time gene therapy injection for wet age-related macular degeneration, against an active comparator in 311 patients. For a micro-cap company with few other products, this readout is the main driver of its value, and the result will show whether the therapy can match or beat standard care on vision improvement.

If it works: A positive result could position Ixo-vec as a durable alternative to repeated eye injections, giving Adverum a commercial product in a large patient market. That outcome might attract partnership interest or funding to advance the drug.

If it fails: Phase 3 trials often fail to meet their primary endpoint, and a miss or safety problem could leave Adverum without a lead asset and with limited cash. Any delay in the readout would also pressure the company, given its small size.

AI-written from the trial record. Speculative, and not investment advice.

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

311 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Nov 2030

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 Early Treatment Diabetic Retinopathy Study (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 criteria 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 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: * Incisional glaucoma surgery (i.e., glaucoma drainage implant/shunt or trabeculectomy) * Ocular angle-based surgery (i.e., goniotomy or canaloplasty) * Minimally Invasive Glaucoma Surgery (MIGS) in the study eye. * Angle-based glaucoma surgery (e.g., Argon or Selective Laser Trabeculoplasty) 5. Any history of intraocular pressure (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.

blindness (disorder) eye disorder wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neovascular age-related macular degeneration (NAMD) Wet AMD

Contacts and locations

Locations

  • Adverum Clinical Site 100

    Beverly Hills, California, 90211, United States

  • Adverum Clinical Site 107

    The Woodlands, Texas, 77384, United States

  • Adverum Clinical Site 108

    Bellaire, Texas, 77401, United States

  • Adverum Clinical Site 109

    Bakersfield, California, 93309, United States

  • Adverum Clinical Site 110

    Philadelphia, Pennsylvania, 19107, United States

  • Adverum Clinical Site 116

    Lakewood, Colorado, 80228, United States

  • Adverum Clinical Site 120

    St. Petersburg, Florida, 33711, United States

  • Adverum Clinical Site 122

    West Columbia, South Carolina, 29169, United States

  • Adverum Clinical Site 123

    Abilene, Texas, 79606, United States

  • Adverum Clinical Site 124

    Pompano Beach, Florida, 33064, United States

  • Adverum Clinical Site 126

    Phoenix, Arizona, 85053, United States

  • Adverum Clinical Site 127

    Austin, Texas, 78705, United States

  • Adverum Clinical Site 131

    Spokane, Washington, 99204, United States

  • Adverum Clinical Site 140

    Sacramento, California, 95825, United States

  • Adverum Clinical Site 144

    Rapid City, South Dakota, 57701, United States

  • Adverum Clinical Site 159

    Tucson, Arizona, 85704, United States

  • Adverum Clinical Site 162

    McAllen, Texas, 78503, United States

  • Adverum Clinical Site 163

    Southaven, Mississippi, 38671, United States

  • Adverum Clinical Site 164

    Riverside, California, 92505, United States

  • Adverum Clinical Site 165

    Waterford, Connecticut, 06385, United States

  • Adverum Clinical Site 167

    Detroit, Michigan, 48201, United States

  • Adverum Clinical Site 168

    Jacksonville, Florida, 32216, United States

  • Adverum Clinical Site 169

    Fullerton, California, 92835, United States

  • Adverum Clinical Site 171

    Teaneck, New Jersey, 07666, United States

  • Adverum Clinical Site 172

    Encino, California, 91436, United States

  • Adverum Clinical Site 175

    Santa Barbara, California, 93103, United States

  • Adverum Clinical Site 176

    Fort Lauderdale, Florida, 33308, United States

  • Adverum Clinical Site 178

    Phoenix, Arizona, 85021, United States

  • Adverum Clinical Site 179

    Oak Forest, Illinois, 60452, United States

  • Adverum Clinical Site 181

    Erie, Pennsylvania, 16507, United States

  • Adverum Clinical Site 182

    Augusta, Georgia, 30909, United States

  • Adverum Clinical Site 183

    South Miami, Florida, 33143, United States

  • Adverum Clinical Site 184

    Deerfield Beach, Florida, 33064, United States

  • Adverum Clinical Site 185

    San Antonio, Texas, 78240, United States

  • Adverum Clinical Site 186

    Durham, North Carolina, 27705, United States

  • Adverum Clinical Site 187

    Wausau, Wisconsin, 54403, United States

  • Adverum Clinical Site 188

    Houston, Texas, 77030, United States

  • Adverum Clinical Site 189

    Walnut Creek, California, 94598, United States

  • Adverum Clinical Site 190

    St Louis, Missouri, 63128, United States

  • Adverum Clinical Site 193

    Tampa, Florida, 33617, United States

  • Adverum Clinical Site 194

    Dallas, Texas, 75231, United States

  • Adverum Clinical Site 195

    Carmel, Indiana, 46032, United States

  • Adverum Clinical Site 196

    Asheville, North Carolina, 28803, United States

  • Adverum Clinical Site 197

    Hagerstown, Maryland, 21740, United States

  • Adverum Clinical Site 198

    Springdale, Arkansas, 72764, United States

  • Adverum Clinical Site 199

    Lynchburg, Virginia, 24502, United States

  • Adverum Clinical Site 200

    Denver, Colorado, 80222, United States

  • Adverum Clinical Site 201

    Campbell, California, 95008, United States

  • Adverum Clinical Site 202

    Torrance, California, 90503, United States

  • Adverum Clinical Site 204

    Hagerstown, Maryland, 21740, United States

  • Adverum Clinical Site 205

    Carmel, Indiana, 46032, United States

  • Adverum Clinical Site 207

    Oak Park, Illinois, 60304, United States

  • Adverum Clinical Site 208

    Charleston, South Carolina, 29414, United States

  • Adverum Clinical Site 209

    Wake Forest, North Carolina, 27587, United States

  • Adverum Clinical Site 211

    Greensboro, North Carolina, 27401, United States

  • Adverum Clinical Site 212

    Sacramento, California, 95841, United States

  • Adverum Clinical Site 213

    Orlando, Florida, 32806, United States

  • Adverum Clinical Site 214

    Lakeland, Florida, 33805, United States

  • Adverum Clinical Site 215

    Redlands, California, 92374, United States

  • Adverum Clinical Site 216

    Madison, Mississippi, 39110, United States

  • Adverum Clinical Site 218

    Katy, Texas, 77494, United States

  • Adverum Clinical Site 219

    Winston-Salem, North Carolina, 27103, United States

  • Adverum Clinical Site 220

    Hickory, North Carolina, 28602, United States

  • Adverum Clinical Site 221

    Fort Myers, Florida, 33912, United States

  • Adverum Clinical Site 222

    Ladson, South Carolina, 29456, United States

  • Adverum Clinical Site 223

    Gilbert, Arizona, 85297, United States

  • Adverum Clinical Site 224

    Huntington Beach, California, 92647, United States

  • Adverum Clinical Site 225

    Liverpool, New York, 13088, United States

  • Adverum Clinical Site 227

    Burleson, Texas, 76028, United States

  • Adverum Clinical Site 228

    Schertz, Texas, 78154, United States

  • Adverum Clinical Site 229

    Scottsdale, Arizona, 85255, United States

  • Adverum Clinical Site 230

    Pensacola, Florida, 32503, United States

  • Adverum Clinical Site 231

    The Woodlands, Texas, 77384, United States

  • Adverum Clinical Site 232

    San Marcos, Texas, 78666, United States

  • Adverum Clinical Site 234

    Cary, North Carolina, 27511, United States

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