PDS Ranibizumab Trial for DME
Phase 3
634
about 8.1 years
18+
91 sites in AZ, CA, CO +27
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to 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 Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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