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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04597632




Registration number
NCT04597632
Ethics application status
Date submitted
1/10/2020
Date registered
22/10/2020

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2020-002349-40
Secondary ID [2] 0 0
CRTH258A2303E1
Universal Trial Number (UTN)
Trial acronym
TALON Ext
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - brolucizumab

Experimental: brolucizumab 6 mg - 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: Drugs: brolucizumab
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye
Timepoint [1] 0 0
Up to Week 56
Primary outcome [2] 0 0
Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye
Timepoint [2] 0 0
Extension study baseline, average of Week 52 and Week 56
Secondary outcome [1] 0 0
Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye
Timepoint [1] 0 0
Extension study baseline, average of Week 52 and Week 56
Secondary outcome [2] 0 0
Number (%) of Subjects With Presence of IRF and/or SRF, and Sub-RPE Fluid in the Study Eye at Week 52 and Week 56 Overall and by Core Study Treatment Arm
Timepoint [2] 0 0
Weeks 52 and 56
Secondary outcome [3] 0 0
Last Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study by Core Study Randomized Treatment Arm
Timepoint [3] 0 0
up to Week 56
Secondary outcome [4] 0 0
Maximal Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study
Timepoint [4] 0 0
up to Week 56
Secondary outcome [5] 0 0
Number (%) of Subjects With Change in Duration of Last Interval With no Disease Activity Between Baseline of the Extension Study and Week 56 by Core Study Treatment Arm
Timepoint [5] 0 0
Extension study baseline, up to Week 56
Secondary outcome [6] 0 0
Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the Study Eye
Timepoint [6] 0 0
Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.
Secondary outcome [7] 0 0
Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term
Timepoint [7] 0 0
Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.

Eligibility
Key inclusion criteria
1. Signed informed consent
2. Successfully completed TALON core study at week 64 (End of Study)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/03/2023
Sample size
Target
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Albury
Recruitment hospital [2] 0 0
Novartis Investigative Site - Hurstville
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parramatta
Recruitment hospital [4] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [5] 0 0
Novartis Investigative Site - Glen Waverley
Recruitment hospital [6] 0 0
Novartis Investigative Site - Rowville
Recruitment hospital [7] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2220 - Hurstville
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment postcode(s) [4] 0 0
2000 - Sydney
Recruitment postcode(s) [5] 0 0
3150 - Glen Waverley
Recruitment postcode(s) [6] 0 0
3179 - Rowville
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
Belgium
State/province [6] 0 0
Hasselt
Country [7] 0 0
Czechia
State/province [7] 0 0
CZE
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha 10
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha
Country [10] 0 0
France
State/province [10] 0 0
Indre Et Loire
Country [11] 0 0
France
State/province [11] 0 0
Rhone
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Creteil
Country [14] 0 0
France
State/province [14] 0 0
Marseille
Country [15] 0 0
France
State/province [15] 0 0
Montauban
Country [16] 0 0
France
State/province [16] 0 0
Nantes Cedex 1
Country [17] 0 0
France
State/province [17] 0 0
Paris cedex 10
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Rueil Malmaison
Country [20] 0 0
Germany
State/province [20] 0 0
Freiburg
Country [21] 0 0
Germany
State/province [21] 0 0
Leipzig
Country [22] 0 0
Germany
State/province [22] 0 0
Mainz
Country [23] 0 0
Israel
State/province [23] 0 0
Jerusalem
Country [24] 0 0
Israel
State/province [24] 0 0
Ramat Gan
Country [25] 0 0
Israel
State/province [25] 0 0
Zerifin
Country [26] 0 0
Italy
State/province [26] 0 0
PG
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Gyeonggi Do
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seocho Gu
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Busan
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Daegu
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Malaysia
State/province [32] 0 0
Melaka Malaysia
Country [33] 0 0
Malaysia
State/province [33] 0 0
Selangor
Country [34] 0 0
Netherlands
State/province [34] 0 0
Den Bosch
Country [35] 0 0
Netherlands
State/province [35] 0 0
Nijmegen
Country [36] 0 0
Portugal
State/province [36] 0 0
Porto
Country [37] 0 0
Portugal
State/province [37] 0 0
Vila Franca de Xira
Country [38] 0 0
Spain
State/province [38] 0 0
Cataluna
Country [39] 0 0
Spain
State/province [39] 0 0
Catalunya
Country [40] 0 0
Spain
State/province [40] 0 0
Navarra
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
Cordoba
Country [44] 0 0
Spain
State/province [44] 0 0
Zaragoza
Country [45] 0 0
Sweden
State/province [45] 0 0
Oerebro
Country [46] 0 0
Sweden
State/province [46] 0 0
Vasteras
Country [47] 0 0
Switzerland
State/province [47] 0 0
Binningen
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Taiwan
State/province [49] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04597632