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 (TALON Ext)

Novartis

Status and phase: Completed; Phase 3

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: brolucizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04597632

CRTH258A2303E1

2020-002349-40 (EudraCT Number)

Details and patient eligibility

About

The purpose of this extension study was 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 was to assess brolucizumab's potential for long durability up to 20 weeks.

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

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

Full description

This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study.

The maximum study duration for a subject was 56 weeks, including post-treatment follow-up.

There were two periods in this study:

• Treat-to-Control treatment period: from Baseline (Day 1) to Week 52
• Post-treatment follow-up period: from Week 52 to Week 56.

All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).

Treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs.

Enrollment: 248 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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248 participants in 1 patient group

brolucizumab 6 mg

Experimental group

Description:

Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity.

Treatment:

Drug: brolucizumab