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)

• ClinicalTrials.gov Identifier: NCT04597632
• Recruitment Status: Active, not recruiting
• First Posted: October 22, 2020
• Last Update Posted: January 23, 2023
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: October 1, 2020
• First Posted Date: October 22, 2020
• Last Update Posted Date: January 23, 2023
• Actual Study Start Date: December 16, 2020
• Estimated Primary Completion Date: March 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2020)

• Extended durability of brolucizumab in a Treat-to-Control regimen [ Time Frame: 56 weeks ]
  Duration of the last interval with no disease activity up to week 56
• Functional outcomes of brolucizumab in a Treat-to-Control regimen [ Time Frame: Baseline, 52 and 56 weeks ]
  Change in BCVA from baseline at Week 52 and Week 56

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 15, 2020)

• Anatomical outcome of brolucizumab in all patients - as measured by the change in central subfield thickness [ Time Frame: Baseline, 52 and 56 weeks ]
  Change in central subfield thickness from baseline to Week 52 and Week 56
• Anatomical outcome of brolucizumab in all patients - as assessed by spectral domain ocular coherence tomography [ Time Frame: Baseline, 52 and 56 weeks ]
  Number of visits with presence of intraretinal fluid and/or subretinal fluid, and sub-retinal pigment epithelium fluid in the central subfield, as assessed by spectral domain ocular coherence tomography at week 52 and week 56
• Durability of brolucizumab in all patients - as measured by duration of the last interval with no disease activity [ Time Frame: Baseline and week 56 ]
  Duration of the last interval with no disease activity up to week 56
• Durability of brolucizumab in all patients - as measured by duration of the maximal intervals with no disease activity [ Time Frame: Baseline and week 56 ]
  Duration of the maximal intervals with no disease activity up to week 56
• Durability of brolucizumab in all patients - as measured by change of the duration of last interval with no disease activity [ Time Frame: Baseline and week 56 ]
  Change of the duration of last interval with no disease activity between baseline and week 56
• Functional outcomes of brolucizumab per randomized arm in the core study [ Time Frame: Baseline, 52 and 56 weeks ]
  Change in Best Corrected Visual Acuity (BCVA) from baseline to week 52 and week 56
• Safety of brolucizumab - as measured by the indicence of ocular and non ocular Adverse Events (AEs) [ Time Frame: up to Week 56 ]
  Occurrence of Ocular and Non-ocular AEs up to Week 56

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

Brief 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.

Detailed Description

This study is a 56-week, open-label, one-arm extension study in participants who have completed the CRTH258A2303 study (TALON). Participants who consent and meet all the inclusion and none of the exclusion criteria will be enrolled into this extension study and receive brolucizumab 6 mg in a TtC regimen, irrespective of the treatment received in the core study.

It is estimated that 622 participants from the core study will enter the extension study (10% dropout rate expected). The maximum study duration for one participant is 56 weeks, including post-treatment follow-up.

There will be 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 will be treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).

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

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neovascular Age-related Macular Degeneration

Intervention

Drug: brolucizumab

brolucizumab 6 mg/0.05 mL solution for intravitreal injection

Other Name: RTH258

Study Arms

Experimental: brolucizumab 6 mg

Participants will receive 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 may be changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity.

Intervention: Drug: brolucizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 17, 2023): 256
• Original Estimated Enrollment (submitted: October 15, 2020): 622
• Estimated Study Completion Date: March 31, 2023
• Estimated Primary Completion Date: March 31, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Czechia, France, Germany, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, Portugal, Spain, Sweden, Switzerland, Taiwan, United States

Administrative Information

• NCT Number: NCT04597632
• Other Study ID Numbers: CRTH258A2303E1; 2020-002349-40 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/

• URL: https://www.clinicalstudydatarequest.com/

• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: January 2023