This study will evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered with the PDS Implant compared with ranibizumab delivered as a monthly intravitreal injection in patients with neovascular age-related macular degeneration (nAMD).
Inclusion Criteria
- Initial diagnosis of exudative nAMD within 9 months prior to the screening visit
- Previous treatment with at least three anti-VEGF intravitreal injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD within 6 months prior to the screening visit
- 20/200 or better approximate Snellen equivalent
Exclusion Criteria
- History of vitrectomy surgery, submacular surgery, or other surgical or Laser intervention for AMD
- Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit
- History of glaucoma-filtering surgery, tube shunts, microinvasive glaucoma surgery, corneal transplant
Study Requirements
Have the Implant (pre-filled with 100 mg/ml ranibizumab) surgically inserted on Day 1; patients in the Implant arm will have scheduled safety visit assessments on Days 2 and 7 (± 2 days) and will receive Implant refills with 100 mg/ml ranibizumab Q24W at Week 24 (± 7 days), Week 48 (± 7 days), and Week 72 (± 7 days).
