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Ixo-vec · 3 trials · 3 indications
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
The number of participants who experience an ocular adverse event will be summarized.
The number of participants who experience ocular serious adverse event will be summarized.
The number of participants who experience non-ocular serious adverse event will be summarized.
| Arm | Type | Description |
|---|---|---|
| Ixo-vec | EXPERIMENTAL | Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a single IVT injection of Ixo-vec 6 x 10\^10 vg/eye at Week 1, and sham injections every 8 weeks. |
| Aflibercept | ACTIVE_COMPARATOR | Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a sham injection at Week 1, and aflibercept 2 mg IVT every 8 weeks. |
| Ixo-vec dosing in Contralateral Eye | EXPERIMENTAL | Population of Ixo-vec-Experienced or Ixo-vec Naïve Participants. |
| Name | Type | Description |
|---|---|---|
| Ixo-vec | GENETIC | Ixo-vec will be administered intravitreally. |
| Aflibercept | DRUG | 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 o...
Ixo-vec is being developed for the treatment of neovascular age-related macular degeneration, also called wet AMD, a form of age-related vision loss driven by abnormal blood vessel growth in the retina. It is an investigational gene therapy given as an intraocular treatment and is not yet approved for commercial use.
Ixo-vec is a gene therapy, which means it delivers genetic material into retinal cells rather than supplying a conventional drug repeatedly. It belongs to the AAV vector gene therapy class. The goal of this approach is to enable the eye to produce a therapeutic protein continuously, reducing the need for frequent injections.
Ixo-vec is being developed by Adverum Biotechnologies, Inc., a clinical-stage biotechnology company that trades under the ticker symbol ADVM. Adverum is running the clinical program for the asset in ophthalmology, with a focus on neovascular age-related macular degeneration.
Ixo-vec is in Phase 3 clinical development. It is an investigational gene therapy and has not been approved by the FDA. The program has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, which are intended to support and expedite development of therapies for serious conditions.
Ixo-vec is being studied in three registered trials. The Phase 3 AQUARIUS study, NCT07482176, is recruiting with a planned enrollment of 534 participants. A second Phase 3 study, NCT06856577, is active but not recruiting with 311 participants. A Phase 2 contralateral dosing study, NCT07630649, is recruiting 15 participants.
Yes. Ixo-vec is the short name for ixoberogene soroparvovec, the full name of the gene therapy Adverum Biotechnologies is developing for neovascular age-related macular degeneration. The two names refer to the same investigational asset, so trial records and company updates may use either form.