Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration

Last updated: July 11, 2025
Sponsor: Adverum Biotechnologies, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Ixo-vec

Aflibercept

Clinical Study ID

NCT06856577
ADVM-022-12
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to provide informed consent (or have a legally authorizedrepresentative who is able and willing to provide informed consent) prior to anystudy 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 nAMDdisease 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 ScreeningVisit 1.

  5. Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening

  6. Able to reliably use eye drops per protocol

Exclusion

Exclusion Criteria:

General Exclusion Criteria

  1. History of a medical condition giving reasonable suspicion of a condition thatcontraindicates the use of Ixo-vec, compromises the participant's ability to complywith the planned study activities, or that might affect the interpretation of theresults of the study or render the participant at high risk for treatmentcomplications in the opinion of the Investigator. History of severe coronavirusdisease (COVID-19) infection may meet this exclusion criteria if, in the opinion ofthe 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) ormedical device in the study eye within 3 months of Screening Visit 1 or 5 half-livesof the IMP prior to dosing with Ixo-vec, whichever is longer.

  4. Female participants who are pregnant or breastfeeding or who intend to becomepregnant or breastfeed in the future.

  5. History or evidence of any of the following cardiovascular diseases:

  6. Myocardial infarction in the 6-month period prior to Day 1.

  7. Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg ordiastolic blood pressure > 100 mmHg.

  8. Stroke in the 6-month period prior to Day 1.

  9. History of ongoing bleeding disorders

  10. Use of systemic immunosuppressive drugs within 90 days prior to Screening Visit 1.

  11. Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% duringscreening

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:

  3. Intraocular or refractive surgery within 90 days prior to Screening Visit 1 (Day -56 to Day -49).

  4. Any previous penetrating keratoplasty or vitrectomy.

  5. Any previous panretinal photocoagulation.

  6. Any previous submacular surgery, other surgical intervention (including portdelivery system) or laser treatment for age related macular degeneration.

  7. Any history or evidence of retinal detachment (with or without repair) or retinalpigment epithelium rip/tear in the study eye, as determined by the Investigatorduring screening or at Day 1.

  8. Uncontrolled ocular hypertension or glaucoma in the study eye from Screening Visit 1to Week 1.

  9. Any history of intraocular pressure (IOP) elevation related to topical steroidadministration in either eye.

  10. Any history of uveitis or inflammation (grade trace or above) except mildanticipated post operative inflammation that resolved in either eye.

  11. Any history of treatment with complement inhibitors for geographic atrophy in thestudy eye.

  12. Known history of ocular herpes simplex virus, varicella-zoster virus, orcytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye.

Study Design

Total Participants: 284
Treatment Group(s): 2
Primary Treatment: Ixo-vec
Phase: 3
Study Start date:
February 28, 2025
Estimated Completion Date:
March 25, 2030

Study Description

The primary objective of this study is to evaluate the non-inferiority in efficacy of a single intravitreal (IVT) injection of Ixo-vec 6 x 10^10 vector genome (vg)/eye compared to an active comparator.

Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. Ixo-vec (also known as ADVM-022 or AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD. Ixo-vec is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Safety, tolerability, and efficacy will be evaluated throughout this study. 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 post-treatment.

Connect with a study center

  • Adverum Clinical Site 223

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • Adverum Clinical Site 126

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Adverum Clinical Site 178

    Phoenix, Arizona 85021
    United States

    Active - Recruiting

  • Adverum Clinical Site 229

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Adverum Clinical Site 159

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Adverum Clinical Site 198

    Springdale, Arkansas 72764
    United States

    Active - Recruiting

  • Adverum Clinical Site 109

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Adverum Clinical Site 100

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Adverum Clinical Site 201

    Campbell, California 95008
    United States

    Active - Recruiting

  • Adverum Clinical Site 172

    Encino, California 91436
    United States

    Active - Recruiting

  • Adverum Clinical Site 169

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Adverum Clinical Site 164

    Riverside, California 92505
    United States

    Active - Recruiting

  • Adverum Clinical Site 140

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Adverum Clinical Site 212

    Sacramento, California 95841
    United States

    Active - Recruiting

  • Adverum Clinical Site 175

    Santa Barbara, California 93103
    United States

    Active - Recruiting

  • Adverum Clinical Site 189

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Adverum Clinical Site 200

    Denver, Colorado 80222
    United States

    Active - Recruiting

  • Adverum Clinical Site 116

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Adverum Clinical Site 165

    Waterford, Connecticut 06385
    United States

    Active - Recruiting

  • Adverum Clinical Site 184

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • Adverum Clinical Site 176

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Adverum Clinical Site 221

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Adverum Clinical Site 168

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Adverum Clinical Site 213

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Adverum Clinical Site 230

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Adverum Clinical Site 124

    Pompano Beach, Florida 33064
    United States

    Active - Recruiting

  • Adverum Clinical Site 120

    Saint Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Adverum Clinical Site 183

    South Miami, Florida 33143
    United States

    Active - Recruiting

  • Adverum Clinical Site 182

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • Adverum Clinical Site 149

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • Adverum Clinical Site 179

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Adverum Clinical Site 207

    Oak Park, Illinois 60304
    United States

    Active - Recruiting

  • Adverum Clinical Site 195

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • Adverum Clinical Site 205

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • Adverum Clinical Site 197

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Adverum Clinical Site 204

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Adverum Clinical Site 167

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Adverum Clinical Site 216

    Madison, Mississippi 39110
    United States

    Active - Recruiting

  • Adverum Clinical Site 163

    Southaven, Mississippi 38671
    United States

    Active - Recruiting

  • Adverum Clinical Site 190

    Saint Louis, Missouri 63128
    United States

    Active - Recruiting

  • Adverum Clinical Site 225

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Adverum Clinical Site 196

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Adverum Clinical Site 211

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Adverum Clinical Site 209

    Wake Forest, North Carolina 27587
    United States

    Active - Recruiting

  • Adverum Clinical Site 219

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Adverum Clinical Site 181

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • Adverum Clinical Site 110

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Adverum Clinical Site 222

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Adverum Clinical Site 122

    West Columbia, South Carolina 29169
    United States

    Active - Recruiting

  • Adverum Clinical Site 123

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Adverum Clinical Site 127

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Adverum Clinical Site 108

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Adverum Clinical Site 227

    Burleson, Texas 76028
    United States

    Active - Recruiting

  • Adverum Clinical Site 194

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Adverum Clinical Site 188

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Adverum Clinical Site 162

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Adverum Clinical Site 185

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Adverum Clinical Site 107

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Adverum Clinical Site 199

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Adverum Clinical Site 187

    Wausau, Wisconsin 54403
    United States

    Active - Recruiting

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