CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 415 enrolled
Drug / intervention
PDS Implant filled with 100 mg/mL Ranibizumab +1 moredrug
Likely dose
PDS Implant 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.

Search/NCT03677934
NCT03677934Phase 3Completed
CompareCT.gov

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 Neovascular Age-Related Macular Degeneration

Hoffmann-La Roche·interventional·Posted Sep 19, 2018·Updated Oct 4, 2022

In Brief

A Phase 3 clinical trial evaluating PDS Implant filled with 100 mg/mL Ranibizumab and Intravitreal Injections of 10 mg/mL Ranibizumab for Neovascular Age-Related Macular Degeneration. Completed, enrolled 415 participants across 77 sites.

Detailed Summary

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor \[VA\]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeovascular Age-Related Macular Degeneration
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2018
Enrollment StartSep 12, 2018
Primary CompletionMay 22, 2020
Study CompletionJun 9, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.8 years ago

Interventions

PDS Implant filled with 100 mg/mL Ranibizumabdrug

Will be administered as per the schedule described in individual arm.

Intravitreal Injections of 10 mg/mL Ranibizumabdrug

Will be administered as per the schedule described in individual arm.