Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular 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)
Adverum Biotechnologies, Inc.
284 participants
Feb 28, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
- Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMD disease activity at Screening Visit 1.
- At least 50 years old at Screening Visit 1.
- 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.
- Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening
- Able to reliably use eye drops per protocol
Exclusion Criteria26
- Received any prior gene therapy.
- 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.
- Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future.
- History or evidence of any of the following cardiovascular diseases:
- Myocardial infarction in the 6-month period prior to Week 1.
- Uncontrolled hypertension defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg during screening.
- Stroke in the 6-month period prior to Week 1.
- History of ongoing bleeding disorders. The use of aspirin or other anticoagulants (e.g., Factor Xa inhibitors) is permitted.
- 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.
- Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% during screening
- Any active ocular or periocular infection in the study eye from Screening Visit 1.
- History or evidence of the following in the study eye:
- Intraocular or refractive surgery within 5 months prior to Week 1.
- Any previous penetrating keratoplasty or vitrectomy.
- Any previous panretinal photocoagulation.
- Any previous submacular surgery, other surgical intervention (including port delivery system) or laser treatment for age related macular degeneration.
- 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.
- 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)
- Any history of intraocular pressure (IOP) elevation related to topical steroid administration in either eye.
- Any history of uveitis or inflammation (grade trace or above) except mild anticipated post operative inflammation that resolved in either eye.
- Any history of treatment with complement inhibitors for geographic atrophy in the study eye.
- 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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Interventions
Ixo-vec will be administered intravitreally.
Aflibercept will be administered intravitreally.
Locations(79)
View Full Details on ClinicalTrials.gov
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NCT06856577