PDS Ranibizumab Trial for DME
Phase 3
634
about 8.1 years
18+
91 sites in AZ, CA, CO +27
About this study
Researchers are testing a new way to deliver ranibizumab (a medication) into your eye, called the Port Delivery System (PDS), compared to regular injections. The trial also looks at how safe it is to re-implant the PDS after it's been used before. Participants with diabetic macular edema will receive either the PDS or standard injections every 24 weeks.
Based on ClinicalTrials.gov records.
What participants do
- 1.Receive Intravitreal Ranibizumab 0.5 mg Injection
- 2.Take PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
- 3.Take Ranibizumab refill exchange
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
ranibizumab, SENSORY ORGANS
injection, injection (Injection)
Primary: Substudy: Number of Participants With Adverse Events of Special Interests (AESIs) and Severity of AESIs, Substudy: Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of Ocular and Systemic AEs
Secondary: Change From Baseline in Central Subfield Thickness (CST) as Measured on Spectral Domain Optical Coherence Tomography (SD-OCT) Over Time, Change From Baseline in ETDRS-DRSS Score Over Time, Change From Baseline in Total Macular Volume as Measured on SD-OCT Over Time, Change from Baseline in BCVA as Measured on the ETDRS Chart Over Time, Incidence and Severity of Non-ocular AEs, Incidence and Severity of Ocular AEs, Incidence, Severity, and Duration of AEs of Special Interest, PK Parameter: Maximum Serum Concentration (Cmax)
implantable