MedTrace Logo

Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD

NCT03386474 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2021-01-05

Study results available
· View outcomes & findings →

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).

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

Brolucizumab 6 mg

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

DRUG

Aflibercept 2 mg

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2018-09-06
Completion
2018-09-06
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386474 on ClinicalTrials.gov