Primary Outcomes

Measure: Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)

Time: Baseline up to Week 144

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Measure: Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)

Time: Baseline up to Week 144

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Measure: Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) for Participants who Receive the PDS Implant in the Study

Time: Baseline up to Week 144

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Secondary Outcomes

Description: 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 Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters

Time: Baseline up to Week 144

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Measure: Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time

Time: Baseline up to Week 144

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Measure: Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time

Time: Baseline up to Week 144

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Measure: Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time

Time: Baseline up to Week 144

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Measure: Change from Baseline in Center Point Thickness Over Time

Time: Baseline up to Week 144

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Measure: Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, Fourth, and Fifth Refill-exchange Interval

Time: Weeks 16 to Week 136

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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

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Secondary Outcomes

Measure: Change from baseline in BCVA score over time

Time: Baseline up to Week 72

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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

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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

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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

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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

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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

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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

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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

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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

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Measure: Change from baseline in center point thickness (CPT) up to and including Week 72

Time: Baseline up to Week 72

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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

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Measure: Incidence and severity of ocular and systemic (non-ocular) adverse events in Q36W compared with Q24W

Time: Baseline up to Week 72

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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

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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

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Measure: Observed serum concentration of ranibizumab at specified timepoints

Time: Baseline to Week 72

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Measure: Incidence of treatment-emergent ADAs during the study

Time: Baseline to Week 72

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