RECRUITING

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

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Conditions

Neovascular Age-Related Macular Degeneration (nAMD)Wet AMDIxoberogene soroparvovecIxo-vecAfliberceptNeovascular age-related macular degenerationnAMDADVMADVM-022ADVM-022-12wAMDWet Age-related Macular DegenerationCNVNeovascular AMDAAVAAV vectorAAV.7m8-afliberceptAAV.7m8Gene therapyEye diseaseBlindnessAdeno-associated viruses

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-02-28
Study Completion:2030-03-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06856577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. At least 50 years old at Screening Visit 1.
  4. 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. 5. Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening
  6. 6. Able to reliably use eye drops per protocol
  1. 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. 2. Received any prior gene therapy.
  3. 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. 4. Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future.
  5. 5. History or evidence of any of the following cardiovascular diseases:
  6. 1. Myocardial infarction in the 6-month period prior to Day 1.
  7. 2. Uncontrolled hypertension defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg.
  8. 3. Stroke in the 6-month period prior to Day 1.
  9. 6. History of ongoing bleeding disorders
  10. 7. Use of systemic immunosuppressive drugs within 90 days prior to Screening Visit 1.
  11. 8. Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% during screening
  12. 1. Any active ocular or periocular infection in the study eye from Screening Visit 1.
  13. 2. History or evidence of the following in the study eye:
  14. 1. Intraocular or refractive surgery within 90 days prior to Screening Visit 1 (Day -56 to Day -49).
  15. 2. Any previous penetrating keratoplasty or vitrectomy.
  16. 3. Any previous panretinal photocoagulation.
  17. 4. Any previous submacular surgery, other surgical intervention (including port delivery system) or laser treatment for age related macular degeneration.
  18. 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 Day 1.
  19. 4. Uncontrolled ocular hypertension or glaucoma in the study eye from Screening Visit 1 to Week 1.
  20. 5. Any history of intraocular pressure (IOP) elevation related to topical steroid administration in either eye.
  21. 6. Any history of uveitis or inflammation (grade trace or above) except mild anticipated post operative inflammation that resolved in either eye.
  22. 7. Any history of treatment with complement inhibitors for geographic atrophy in the study eye.
  23. 8. Known history of ocular herpes simplex virus, varicella-zoster virus, or cytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye.

Contacts and Locations

Study Contact

Adverum Study Contact
CONTACT
650-656-9323
ADVM02212ClinOp@adverum.com

Principal Investigator

Adam Turpcu, PhD
STUDY_DIRECTOR
Adverum Biotechnologies, Inc.

Study Locations (Sites)

Adverum Clinical Site 159
Tucson, Arizona, 85704
United States
Adverum Clinical Site 169
Fullerton, California, 92835
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 124
Pompano Beach, Florida, 33064
United States
Adverum Clinical Site 122
West Columbia, South Carolina, 29169
United States

Collaborators and Investigators

Sponsor: Adverum Biotechnologies, Inc.

  • Adam Turpcu, PhD, STUDY_DIRECTOR, Adverum Biotechnologies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28
Study Completion Date2030-03-25

Study Record Updates

Study Start Date2025-02-28
Study Completion Date2030-03-25

Terms related to this study

Keywords Provided by Researchers

  • Ixoberogene soroparvovec
  • Ixo-vec
  • Aflibercept
  • Neovascular age-related macular degeneration
  • nAMD
  • ADVM
  • ADVM-022
  • ADVM-022-12
  • Wet AMD
  • wAMD
  • Wet Age-related Macular Degeneration
  • CNV
  • Neovascular AMD
  • AAV
  • AAV vector
  • AAV.7m8-aflibercept
  • AAV.7m8
  • Gene therapy
  • Eye disease
  • Blindness
  • Adeno-associated viruses

Additional Relevant MeSH Terms

  • Neovascular Age-Related Macular Degeneration (nAMD)
  • Wet AMD