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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 )

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: brolucizumab Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: brolucizumab
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
Other Name: RTH258


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597632


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04597632    
Other Study ID Numbers: CRTH258A2303E1
2020-002349-40 ( EudraCT Number )
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Individual Participant Data (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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
neovascular age-related macular degeneration
wet age-related macular degeneration
wet AMD
 choroidal neovascularization
individualized treatment
anti-VEGF
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases