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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, also known as ixoberogene soroparvovec, is an investigational gene therapy being developed for neovascular age-related macular degeneration (nAMD), including wet AMD. It is designed to treat this condition, which affects the retina and can lead to vision loss.
Ixo-vec is a gene therapy, a class of treatment that delivers genetic material to cells. It is being studied for neovascular age-related macular degeneration (nAMD), a condition characterized by abnormal blood vessel growth in the eye.
Ixo-vec is being developed by Adverum Biotechnologies, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this gene therapy for neovascular age-related macular degeneration.
Ixo-vec is currently in Phase 3 clinical trials for neovascular age-related macular degeneration (nAMD). It has received FDA designations including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track, reflecting its potential to address a serious condition.
Ixo-vec is being studied in two Phase 3 trials: NCT06856577, with 311 participants, and NCT07482176 (AQUARIUS), with 284 participants. Both are active in the United States, enrolling adults aged 50 and older with nAMD or wet AMD.
Yes, Ixo-vec is the same as ixoberogene soroparvovec. Both names refer to the same investigational gene therapy being developed for neovascular age-related macular degeneration (nAMD).