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Evaluating a new gene therapy for wet age-related macular degeneration

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)

Phase 3 Interventional Adverum Biotechnologies, Inc. · NCT06856577

This study is testing a new gene therapy to see if it can help people with wet age-related macular degeneration improve their vision compared to a standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment284 (estimated)
Ages50 Years and up
SexAll
SponsorAdverum Biotechnologies, Inc. Industry-sponsored
Locations79 sites (Gilbert, Arizona and 78 other locations)
Trial IDNCT06856577 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a multi-center, randomized, double-masked, active-comparator-controlled study assessing the efficacy and safety of a single intravitreal injection of Ixoberogene Soroparvovec (Ixo-vec) in participants with neovascular age-related macular degeneration (nAMD). The study aims to determine the non-inferiority of Ixo-vec compared to an active comparator, focusing on changes in best corrected visual acuity (BCVA) over a period of 52 to 56 weeks. Participants will be evaluated for safety, tolerability, and efficacy throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with a diagnosis of neovascular age-related macular degeneration and a specific range of visual acuity scores.

Not a fit: Patients with contraindications to Ixo-vec or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the treatment burden for patients with wet AMD, potentially improving their vision and quality of life.

How similar studies have performed: Previous studies have shown promise with gene therapy approaches for retinal diseases, indicating potential for success with this novel treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Gilbert, Arizona and 78 other locations

+29 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neovascular Age-Related Macular DegenerationWet AMDIxoberogene soroparvovecIxo-vecAfliberceptNeovascular age-related macular degenerationnAMDADVM
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.