An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

• Status: Recruiting
• Trial end date: 2024-02-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this extension study is to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective is to assess brolucizumab's potential for long durability up to 20 weeks.

All eligible participants will be treated with brolucizumab regardless of their treatment in the TALON study.

The study period is 56 weeks including post-treatment follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

1. Signed informed consent

2. Successfully completed TALON core study at week 64 (End of Study)

Exclusion Criteria:

1. Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator

2. Discontinued study treatment in the core study

3. Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion.

4. Pregnant or nursing (lactating) women

5. Women of child-bearing potential not using highly effective methods of contraception