CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 225 enrolled
Drug / intervention
Ranibizumabdrug
Likely dose
Ranibizumab 0.5 mgfrom 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/NCT02510794
NCT02510794Phase 2Completed
CompareCT.gov

A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration

Genentech, Inc.·interventional·Posted Jul 29, 2015·Updated May 6, 2021

In Brief

A Phase 2 clinical trial evaluating Ranibizumab for Macular Degeneration. Completed, enrolled 225 participants across 50 sites.

Detailed Summary

This is a Phase II multicenter, dose-ranging, randomized, active treatment (monthly ITV injection)-controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in participants with subfoveal neovascular age-related macular degeneration (nAMD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Degeneration
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 29, 2015
Enrollment StartSep 28, 2015
Primary CompletionApr 10, 2018
Study CompletionMar 28, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.9 years ago

Interventions

Ranibizumabdrug

Ranibizumab will be administered at dose of 0.5 mg monthly ITV injections of 10-mg/mL formulation or delivered through the implant with three different formulations.