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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)

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
brolucizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring neovascular age-related macular degeneration, wet age-related macular degeneration, wet AMD, choroidal neovascularization, individualized treatment, anti-VEGF

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
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  • Novartis Investigative Site
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  • Novartis Investigative Site
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  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

brolucizumab 6 mg

Arm Description

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.

Outcomes

Primary Outcome Measures

Extended durability of brolucizumab in a Treat-to-Control regimen
Duration of the last interval with no disease activity up to week 56
Functional outcomes of brolucizumab in a Treat-to-Control regimen
Change in BCVA from baseline at Week 52 and Week 56

Secondary Outcome Measures

Anatomical outcome of brolucizumab in all patients - as measured by the change in central subfield thickness
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
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
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
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
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
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)
Occurrence of Ocular and Non-ocular AEs up to Week 56

Full Information

First Posted
October 1, 2020
Last Updated
May 19, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04597632
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
Acronym
TALON Ext
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
neovascular age-related macular degeneration, wet age-related macular degeneration, wet AMD, choroidal neovascularization, individualized treatment, anti-VEGF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
brolucizumab 6 mg
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
brolucizumab
Other Intervention Name(s)
RTH258
Intervention Description
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
Primary Outcome Measure Information:
Title
Extended durability of brolucizumab in a Treat-to-Control regimen
Description
Duration of the last interval with no disease activity up to week 56
Time Frame
56 weeks
Title
Functional outcomes of brolucizumab in a Treat-to-Control regimen
Description
Change in BCVA from baseline at Week 52 and Week 56
Time Frame
Baseline, 52 and 56 weeks
Secondary Outcome Measure Information:
Title
Anatomical outcome of brolucizumab in all patients - as measured by the change in central subfield thickness
Description
Change in central subfield thickness from baseline to Week 52 and Week 56
Time Frame
Baseline, 52 and 56 weeks
Title
Anatomical outcome of brolucizumab in all patients - as assessed by spectral domain ocular coherence tomography
Description
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
Time Frame
Baseline, 52 and 56 weeks
Title
Durability of brolucizumab in all patients - as measured by duration of the last interval with no disease activity
Description
Duration of the last interval with no disease activity up to week 56
Time Frame
Baseline and week 56
Title
Durability of brolucizumab in all patients - as measured by duration of the maximal intervals with no disease activity
Description
Duration of the maximal intervals with no disease activity up to week 56
Time Frame
Baseline and week 56
Title
Durability of brolucizumab in all patients - as measured by change of the duration of last interval with no disease activity
Description
Change of the duration of last interval with no disease activity between baseline and week 56
Time Frame
Baseline and week 56
Title
Functional outcomes of brolucizumab per randomized arm in the core study
Description
Change in Best Corrected Visual Acuity (BCVA) from baseline to week 52 and week 56
Time Frame
Baseline, 52 and 56 weeks
Title
Safety of brolucizumab - as measured by the indicence of ocular and non ocular Adverse Events (AEs)
Description
Occurrence of Ocular and Non-ocular AEs up to Week 56
Time Frame
up to Week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Successfully completed TALON core study at week 64 (End of Study) Exclusion Criteria: Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator Discontinued study treatment in the core study Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion. Pregnant or nursing (lactating) women Women of child-bearing potential not using highly effective methods of contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Novartis Investigative Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Novartis Investigative Site
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Novartis Investigative Site
City
Hurstville
State/Province
New South Wales
ZIP/Postal Code
2220
Country
Australia
Facility Name
Novartis Investigative Site
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Novartis Investigative Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Novartis Investigative Site
City
Glen Waverley
State/Province
Victoria
ZIP/Postal Code
3150
Country
Australia
Facility Name
Novartis Investigative Site
City
Rowville
State/Province
Victoria
ZIP/Postal Code
3179
Country
Australia
Facility Name
Novartis Investigative Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Novartis Investigative Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Novartis Investigative Site
City
Hradec Kralove
State/Province
CZE
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Novartis Investigative Site
City
Saint Cyr sur Loire
State/Province
Indre Et Loire
ZIP/Postal Code
37540
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Novartis Investigative Site
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
F 13008
Country
France
Facility Name
Novartis Investigative Site
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
Novartis Investigative Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Novartis Investigative Site
City
Paris cedex 10
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novartis Investigative Site
City
Rueil Malmaison
ZIP/Postal Code
92500
Country
France
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novartis Investigative Site
City
Zerifin
ZIP/Postal Code
6093000
Country
Israel
Facility Name
Novartis Investigative Site
City
Perugia
State/Province
PG
ZIP/Postal Code
06100
Country
Italy
Facility Name
Novartis Investigative Site
City
Bundang Gu
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Seocho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
602739
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Daegu
ZIP/Postal Code
705703
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
07301
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Melaka
State/Province
Melaka Malaysia
ZIP/Postal Code
75000
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
40000
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Den Bosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Nijmegen
ZIP/Postal Code
6525 EX
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Novartis Investigative Site
City
Vila Franca de Xira
ZIP/Postal Code
2600-009
Country
Portugal
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08022
Country
Spain
Facility Name
Novartis Investigative Site
City
Sant Cugat
State/Province
Catalunya
ZIP/Postal Code
08190
Country
Spain
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novartis Investigative Site
City
Burjassot
State/Province
Valencia
ZIP/Postal Code
46100
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
14012
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Novartis Investigative Site
City
Oerebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Vasteras
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Novartis Investigative Site
City
Binningen
ZIP/Postal Code
4102
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
103616
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing URL
https://www.clinicalstudydatarequest.com/

Learn more about this trial

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

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