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Title A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy. Safe and Pharmacokinetics of the Port Delivery System with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration
Therapeutic Area Macular Degeneration
Principal Investigator Nadia Waheed, MD
Min Age 50 Years
Gender All
Contact Michael Dixon
More Information


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). 

Study Details

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).