At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 174 enrolled
Drug / intervention
PDS Implant Pre-Filled with 100 mg/mL Ranibizumab +1 moredrug
Likely dose
PDS Implant Pre-Filled with 100 mg/mL Ranibizumabfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Randomized Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Retinopathy
In Brief
A Phase 3 clinical trial evaluating PDS Implant Pre-Filled with 100 mg/mL Ranibizumab and Intravitreal Ranibizumab 0.5 mg Injection for Diabetic Retinopathy. Completed, enrolled 174 participants across 65 sites in 2 countries.
Detailed Summary
Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Retinopathy
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartAug 2020
Primary CompletionOct 2022
Study CompletionFeb 2026
TodayJul 2026
First PostedAug 7, 2020
Enrollment StartAug 10, 2020
Primary CompletionOct 3, 2022
Study CompletionFeb 23, 2026
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.9 years ago
Interventions
PDS Implant Pre-Filled with 100 mg/mL Ranibizumabdrug
Will be administered as per the schedule described in individual arm.
Intravitreal Ranibizumab 0.5 mg Injectiondrug
Will be administered as per the schedule described in individual arm.