This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).
Name: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Name: Intravitreal Ranibizumab 0.5 mg Injection
Description: BCVA = Best-Corrected Visual Acuity ETDRS = 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 in BCVA score from baseline averaged over Weeks 60 and 64 as measured using the ETDRS chart Time: Baseline to Week 64Description: ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale
Measure: Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64 Time: Baseline to Week 64Description: CST = central subfield thickness SD-OCT = spectral domain optical coherence tomography
Measure: Change from baseline in CST as measured on SD-OCT at Week 64 Time: Baseline to Week 64Description: DME = diabetic macular edema
Measure: Percentage of participants with DME (defined as CST ≥325 μm on SD-OCT) over time Time: Baseline up to Week 120Description: PDR = proliferative diabetic retinopathy
Measure: Percentage of participants with PDR (defined as a score ≥60 on the ETDRS-DRSS) over time Time: Baseline up to Week 120Allocation: Randomized
Parallel Assignment
There is one SNP
This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W). --- Q24W ---