A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorHoffmann-La Roche

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)

Treatment groups

68 Participants
are divided into 2 treatment groups

Sponsors and collaborators