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

• Status: Completed
• Trial end date: 2018-09-06
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• Sign written informed consent

• Completed the core study, CRTH258A2301, also known as CRTH258-C002 as defined by assessments at Visit 26/Week 96 within ≤12 weeks of the baseline.

Exclusion Criteria:

• Patient discontinued the treatment or the core study prematurely at any time

• Patient received standard of care treatment for nAMD after completion of the core study

• Pregnant or nursing women and women of child-bearing potential

• Stroke or MI (myocardial infarction) within 3 months of the baseline extension visit