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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
451
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
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
Centro Oftalmologico Dr. Charles S.A.
Capital Federal, Argentina
Oftalmos
Capital Federal, Argentina
Grupo Laser Vision
Rosario, Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Eye and Retina Consultants
Hurstville, New South Wales, Australia
Retina Associates Liverpool
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
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.
Time frame: Baseline to Week 72
Change from baseline in BCVA score over time
Time frame: Baseline up to Week 72
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72
Time frame: Baseline to Week 72
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time
Time frame: Baseline up to Week 72
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72
Time frame: Baseline to Week 72
Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time
Time frame: Baseline up to Week 72
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 At Weeks 24, 40 and 72
Time frame: At Weeks 24, 40, 72
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 At Weeks 24, 40 and 72
Time frame: At Weeks 24, 40, 72
Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) total score in the Q36W arm compared with the Q24W arm
Time frame: At Week 40
Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72
Time frame: Baseline to Week 72
Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time
Time frame: Baseline up to Week 72
Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms
Time frame: Baseline up to Week 72
Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in the Q36W and Q24W arms
Time frame: Baseline up to Week 72
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 frame: Baseline up to Week 72
Incidence and severity of adverse device effects in the Q36W and Q24W arms
Time frame: Baseline up to Week 72
Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms
Time frame: Baseline up to Week 72
Change from baseline in center point thickness (CPT) up to and including Week 72
Time frame: Baseline up to Week 72
Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure
Time frame: Week 16 to Week 68
Observed serum concentration of ranibizumab at specified timepoints
Time frame: Baseline to Week 72
Incidence of treatment-emergent ADAs during the study
Time frame: Baseline to Week 72
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Liverpool, New South Wales, Australia
Retina and Macula Specialists
Miranda, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Queensland Eye Institute
Woolloongabba, Queensland, Australia
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