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Report for Clinical Trial NCT04657289
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
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).
1 Interventions
Name: PDS Implant filled with 100 mg/mL Ranibizumab
Description: Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals
Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Type: Drug
Group Labels: 6 Arm A [Q36W Arm A [Q36W] Arm A [Q36W] 36-weeks between refill-exchange procedures Arm B [Q24W Arm B [Q24W] Arm B [Q24W] 24-weeks between refill-exchange procedures
Primary Outcomes
Description: EDTRS = Early Treatment Diabetic Retinopathy Study. A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
Measure: Change from baseline in Best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72, as assessed using the ETDRS chart starting at a distance of 4 meters
Time: Baseline to Week 72
Secondary Outcomes
Measure: Change from baseline in BCVA score over time Time: Baseline up to Week 72
Measure: Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72 Time: Baseline to Week 72
Measure: Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time Time: Baseline up to Week 72
Measure: Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72 Time: Baseline to Week 72
Measure: Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time Time: Baseline up to Week 72
Measure: Percentage of participants who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Week 40 Time: At Week 40
Measure: Percentage of participants with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PPPQ at Week 40 Time: At Week 40
Measure: Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72 Time: Baseline to Week 72
Measure: Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time Time: Baseline up to Week 72
Measure: Change from baseline in center point thickness (CPT) up to and including Week 72 Time: Baseline up to Week 72
Measure: Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure Time: Week 16 to Week 68
Measure: Incidence and severity of ocular and systemic (non-ocular) adverse events in Q36W compared with Q24W Time: Baseline up to Week 72
Measure: Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in Q36W compared with Q24W Time: Baseline up to Week 72
Measure: Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (≤ 37 days of initial implantation) and follow-up period (> 37 days after implantation surgery) in all enrolled participants Time: Baseline up to Week 72
Measure: Observed serum concentration of ranibizumab at specified timepoints Time: Baseline to Week 72
Measure: Incidence of treatment-emergent ADAs during the study Time: Baseline to Week 72
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There are 2 SNPs
SNPs
1 Q24W
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). --- Q36W --- --- Q24W ---
Incidence and severity of ocular and systemic (non-ocular) adverse events in Q36W compared with Q24W. --- Q36W --- --- Q24W ---
Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in Q36W compared with Q24W. --- Q36W --- --- Q24W ---
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). --- Q36W ---
Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in Q36W compared with Q24W. --- Q36W ---