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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)

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

Tracking Information
First Submitted Date  ICMJE October 1, 2020
First Posted Date  ICMJE October 22, 2020
Last Update Posted Date January 23, 2023
Actual Study Start Date  ICMJE December 16, 2020
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-related Macular Degeneration
Intervention  ICMJE Drug: brolucizumab
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
Other Name: RTH258
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 17, 2023)
256
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2020)
622
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Czechia,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Netherlands,   Portugal,   Spain,   Sweden,   Switzerland,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04597632
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP