A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 3b
Masking: Single (Outcomes Assessor)
Masking Description:
- The BCVA examiner will only conduct refraction and BCVA assessments and will be masked to participant study eye assignment and study visit type.
- The BCVA examiner will have no access to a participant's BCVA scores from previous visits and will be aware only of the participant's refraction data from previous visits.
- The BCVA examiner may provide no other direct or indirect participant care.
Primary Purpose: Treatment
Official Title: A Phase IIIb, Global, Multicenter, Randomized, Visual Assessor-Masked Study Of The Efficacy, Safety, And Pharmacokinetics Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab In Patients With Neovascular Age-Related Macular Degeneration (Velodrome)
Estimated Study Start Date: May 6, 2021
Estimated Primary Completion Date: September 21, 2023
Estimated Study Completion Date: September 21, 2023

Arm:
- Experimental: Arm A [Q36W] 36-weeks between refill-exchange procedures
- Active Comparator: Arm B [Q24W] 24-weeks between refill-exchange procedures

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