About this trial
This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.
Eligibility criteria
Qualifiers
Initial diagnosis of nAMD within 9 months prior to the screening visit
Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard-of-care (SOC) within 6 months prior to the screening visit
Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up to the screening visit
Disqualifiers
History of vitrectomy surgery, submacular surgery, or other surgical intervention, all for AMD
Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
Previous treatment with corticosteroid IVT injection or corticosteroid implants
Previous intraocular device implantation (not including intraocular lens implants)
Trial design
Treatments tested in this trial
- PDS With Ranibizumab (100 mg/mL)
- Ranibizumab (10 mg/mL)