Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...