Clinical trial
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery…
NCT04108156 · Hoffmann-La Roche, Industry · Recruiting
Key facts
| NCT number | NCT04108156 |
|---|---|
| Title | A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME |
| Official title | A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda) |
| Acronym | Pagoda |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Diabetic Macular Edema |
| Intervention type | Drug |
| Interventions | PDS Implant Pre-Filled with 100 mg/mL Ranibizumab, Intravitreal Ranibizumab 0.5 mg Injection, Ranibizumab refill exchange |
| Enrollment | 634 |
| Start date | Sep 30, 2019 |
| Primary completion | Nov 16, 2027 |
| Completion | Nov 16, 2027 |
| First posted | Sep 30, 2019 |
| Last update posted | Feb 9, 2026 |
| Countries | United States |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: