Secondary Outcomes
Description: ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale
Measure: Change in BCVA score from baseline averaged over Weeks 60 and 64 as measured with use of the ETDRS chart in the per protocol population
Time: Baseline to Week 64
Measure: Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64 in the efficacy population
Time: Baseline to Week 64
Measure: Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64 in the per protocol population
Time: Baseline to Week 64
Measure: Change from baseline in BCVA as measured on the ETDRS chart over time
Time: Baseline up to Week 120
Measure: Percentage of participants who lose <10, and <5 letters in BCVA from baseline over time
Time: Baseline up to Week 120
Measure: Percentage of participants who gain ≥15, ≥10, ≥5, ≥0 letters in BCVA from baseline over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a BCVA Snellen equivalent of 20/40 or better over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a BCVA Snellen equivalent of 20/200 or worse over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS at Week 64
Time: Baseline to Week 64
Measure: Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS over time
Time: Baseline up to Week 120
Measure: Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS over time
Time: Baseline up to Week 120
Measure: Time to ≥2-step worsening from baseline on the ETDRS-DRSS
Time: Baseline up to Week 120
Measure: Time to ≥3-step worsening from baseline on the ETDRS-DRSS
Time: Baseline up to Week 120
Measure: Change from baseline in ETDRS-DRSS score over time
Time: Baseline up to Week 120
Description: 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 64
Measure: Change from baseline in CST as measured on SD-OCT over time
Time: Baseline up to Week 120
Measure: Change from baseline in total macular volume as measured on SD-OCT over time
Time: Baseline up to Week 120
Description: 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 120
Description: PDR = proliferative diabetic retinopathy
Measure: Time to PDR (defined as a score ≥60 on the ETDRS-DRSS)
Time: Baseline up to Week 120
Measure: Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab within each refill-exchange interval
Time: Baseline up to Week 120
Measure: Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Week 64 among participants in the PDS arm efficacy population
Time: Baseline to Week 64
Measure: Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Week 64 among participants in per protocol population
Time: Baseline to Week 64
Description: Participants in in a subset of patients with bilateral disease who are simultaneously receiving ranibizumab via study eye PDS implant and fellow eye intravitreal injection
Measure: Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Week 64
Time: Baseline to Week 64
Measure: Incidence and severity of ocular adverse events
Time: Baseline to Week 120
Measure: Incidence and severity of non-ocular adverse events
Time: Baseline up to Week 120
Measure: Incidence, severity, and duration of adverse events of special interest
Time: Baseline up to Week 120
Measure: Incidence, severity, and duration of PDS-associated adverse events of special interest during the postoperative period (up to 37 days after initial implantation) and follow-up period (>37 days after implantation surgery)
Time: Baseline up to Week 120
Measure: Serum concentration of ranibizumab observed over time
Time: Baseline up to Week 120
Measure: PK parameter value area under the concentration- time curve over 24 weeks (AUC24W)
Time: Baseline to Week 24
Measure: Pharmacokinetic (PK) parameter maximum serum concentration (Cmax)
Time: Baseline up to Week 120
Measure: PK Parameter minimum serum concentration (Cmin)
Time: Baseline up to Week 120
Measure: PK parameter half-life (t1/2) after PDS implant insertion
Time: Baseline up to Week 120
Measure: Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
Time: Baseline up to Week 120