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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
6176361051
More Information https://www.clinicaltrials.gov/ct2/show/NCT03677934

Overview

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).