CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 151 enrolled
Drug / intervention
Brolucizumab 6 mg +1 moredrug
Likely dose
Brolucizumab 6 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/NCT03386474
NCT03386474Phase 3Completed
CompareCT.gov

A 24-week, Double-masked, Multicenter, Two-arm Extension Study to Collect Safety and Efficacy Data on Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2301 Study

Novartis Pharmaceuticals·interventional·Posted Dec 29, 2017·Updated Jan 5, 2021

In Brief

A Phase 3 clinical trial evaluating Brolucizumab 6 mg and Aflibercept 2 mg for Neovascular Age-related Macular Degeneration. Completed, enrolled 151 participants across 65 sites in 2 countries.

Detailed Summary

The purpose of this extension study was to assess the safety and efficacy of the new formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The medical condition treated in the core and extension trials was neo-vascular age-related macular degeneration (nAMD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeovascular Age-related Macular Degeneration
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 29, 2017
Enrollment StartJan 15, 2018
Primary CompletionSep 6, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.5 years ago

Interventions

Brolucizumab 6 mgdrug

Administered as opthalmic solution for an intravitreal injection to the study eye

Aflibercept 2 mgdrug

Administered as an opthalmic solution for intravitreal injection to the study eye