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RECRUITING

NCT06856577

PHASE3

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

Sponsor: Adverum Biotechnologies, Inc.

View on ClinicalTrials.gov

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.

Official title: A Multi-Center, Randomized, Double-Masked, Active-Comparator-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration (ARTEMIS)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

284

Start Date

2025-02-28

Completion Date

2030-11-23

Last Updated

2025-11-18

Healthy Volunteers

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)Wet AMD

Interventions

GENETIC

Ixo-vec

Ixo-vec will be administered intravitreally.

DRUG

Aflibercept

Aflibercept will be administered intravitreally.

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.

Locations (79)

Adverum Clinical Site 223

Gilbert, Arizona, United States

Adverum Clinical Site 178

Phoenix, Arizona, United States

Adverum Clinical Site 126

Phoenix, Arizona, United States

Adverum Clinical Site 229

Scottsdale, Arizona, United States

Adverum Clinical Site 159

Tucson, Arizona, United States

Adverum Clinical Site 198

Springdale, Arkansas, United States

Adverum Clinical Site 109

Bakersfield, California, United States

Adverum Clinical Site 100

Beverly Hills, California, United States

Adverum Clinical Site 201

Campbell, California, United States

Adverum Clinical Site 172

Encino, California, United States

Adverum Clinical Site 169

Fullerton, California, United States

Adverum Clinical Site 224

Huntington Beach, California, United States

Adverum Clinical Site 215

Redlands, California, United States

Adverum Clinical Site 164

Riverside, California, United States

Adverum Clinical Site 140

Sacramento, California, United States

Adverum Clinical Site 212

Sacramento, California, United States

Adverum Clinical Site 175

Santa Barbara, California, United States

Adverum Clinical Site 202

Torrance, California, United States

Adverum Clinical Site 189

Walnut Creek, California, United States

Adverum Clinical Site 200

Denver, Colorado, United States

Adverum Clinical Site 116

Lakewood, Colorado, United States

Adverum Clinical Site 165

Waterford, Connecticut, United States

Adverum Clinical Site 184

Deerfield Beach, Florida, United States

Adverum Clinical Site 176

Fort Lauderdale, Florida, United States

Adverum Clinical Site 221

Fort Myers, Florida, United States

Adverum Clinical Site 236

Gainesville, Florida, United States

Adverum Clinical Site 168

Jacksonville, Florida, United States

Adverum Clinical Site 214

Lakeland, Florida, United States

Adverum Clinical Site 213

Orlando, Florida, United States

Adverum Clinical Site 230

Pensacola, Florida, United States

Adverum Clinical Site 124

Pompano Beach, Florida, United States

Adverum Clinical Site 183

South Miami, Florida, United States

Adverum Clinical Site 120

St. Petersburg, Florida, United States

Adverum Clinical Site 193

Tampa, Florida, United States

Adverum Clinical Site 182

Augusta, Georgia, United States

Adverum Clinical Site 149

‘Aiea, Hawaii, United States

Adverum Clinical Site 179

Oak Forest, Illinois, United States

Adverum Clinical Site 207

Oak Park, Illinois, United States

Adverum Clinical Site 195

Carmel, Indiana, United States

Adverum Clinical Site 205

Carmel, Indiana, United States

Adverum Clinical Site 197

Hagerstown, Maryland, United States

Adverum Clinical Site 204

Hagerstown, Maryland, United States

Adverum Clinical Site 167

Detroit, Michigan, United States

Adverum Clinical Site 216

Madison, Mississippi, United States

Adverum Clinical Site 163

Southaven, Mississippi, United States

Adverum Clinical Site 190

St Louis, Missouri, United States

Adverum Clinical Site 171

Teaneck, New Jersey, United States

Adverum Clinical Site 225

Liverpool, New York, United States

Adverum Clinical Site 196

Asheville, North Carolina, United States

Adverum Clinical Site 234

Cary, North Carolina, United States

Adverum Clinical Site 186

Durham, North Carolina, United States

Adverum Clinical Site 211

Greensboro, North Carolina, United States

Adverum Clinical Site 220

Hickory, North Carolina, United States

Adverum Clinical Site 209

Wake Forest, North Carolina, United States

Adverum Clinical Site 219

Winston-Salem, North Carolina, United States

Adverum Clinical Site 181

Erie, Pennsylvania, United States

Adverum Clinical Site 110

Philadelphia, Pennsylvania, United States

Adverum Clinical Site 208

Charleston, South Carolina, United States

Adverum Clinical Site 222

Ladson, South Carolina, United States

Adverum Clinical Site 122

West Columbia, South Carolina, United States

Adverum Clinical Site 144

Rapid City, South Dakota, United States

Adverum Clinical Site 123

Abilene, Texas, United States

Adverum Clinical Site 127

Austin, Texas, United States

Adverum Clinical Site 108

Bellaire, Texas, United States

Adverum Clinical Site 227

Burleson, Texas, United States

Adverum Clinical Site 194

Dallas, Texas, United States

Adverum Clinical Site 188

Houston, Texas, United States

Adverum Clinical Site 218

Katy, Texas, United States

Adverum Clinical Site 162

McAllen, Texas, United States

Adverum Clinical Site 151

San Antonio, Texas, United States

Adverum Clinical Site 185

San Antonio, Texas, United States

Adverum Clinical Site 232

San Marcos, Texas, United States

Adverum Clinical Site 228

Schertz, Texas, United States

Adverum Clinical Site 107

The Woodlands, Texas, United States

Adverum Clinical Site 231

The Woodlands, Texas, United States

Adverum Clinical Site 199

Lynchburg, Virginia, United States

Adverum Clinical Site 131

Spokane, Washington, United States

Adverum Clinical Site 152

Morgantown, West Virginia, United States

Adverum Clinical Site 187

Wausau, Wisconsin, United States