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
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
2 other identifiers
interventional
248
16 countries
60
Brief Summary
The purpose of this extension study was 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 was to assess brolucizumab's potential for long durability up to 20 weeks. All eligible participants were treated with brolucizumab regardless of their treatment in the TALON study. The study period was 56 weeks including post-treatment follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2020
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
December 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedResults Posted
Study results publicly available
April 4, 2024
CompletedOctober 9, 2024
October 1, 2024
2.3 years
October 1, 2020
February 27, 2024
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye
Number of subjects in every 4 weeks (q4w), every 8 weeks (q8w), every 12 weeks (q12w) and every 20 weeks (q20w) intervals at last interval with no disease activity up to Week 56. 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
Up to Week 56
Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye
Best-Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. The average change in BCVA from Baseline of the extension study at Week 52 and Week 56 was estimated by an analysis of variance (ANOVA) with baseline age categories, baseline BCVA categories and treatment arm in the core study included as fixed effects. Last observation carried forward (LOCF) was used to impute missing BCVA values.
Extension study baseline, average of Week 52 and Week 56
Secondary Outcomes (7)
Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye
Extension study baseline, average of Week 52 and Week 56
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
Weeks 52 and 56
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
up to Week 56
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
up to Week 56
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
Extension study baseline, up to Week 56
- +2 more secondary outcomes
Study Arms (1)
brolucizumab 6 mg
EXPERIMENTALParticipants 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.
Interventions
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Successfully completed TALON core study at week 64 (End of Study)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Novartis Investigative Site
Huntington Beach, California, 92647, United States
Novartis Investigative Site
Fort Lauderdale, Florida, 33309, United States
Novartis Investigative Site
Indianapolis, Indiana, 46280, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55435, United States
Novartis Investigative Site
Germantown, Tennessee, 38138, United States
Novartis Investigative Site
Albury, New South Wales, 2640, Australia
Novartis Investigative Site
Hurstville, New South Wales, 2220, Australia
Novartis Investigative Site
Parramatta, New South Wales, 2150, Australia
Novartis Investigative Site
Sydney, New South Wales, 2000, Australia
Novartis Investigative Site
Glen Waverley, Victoria, 3150, Australia
Novartis Investigative Site
Rowville, Victoria, 3179, Australia
Novartis Investigative Site
Nedlands, Western Australia, 6009, Australia
Novartis Investigative Site
Hasselt, 3500, Belgium
Novartis Investigative Site
Hradec Králové, CZE, 500 05, Czechia
Novartis Investigative Site
Prague, 100 34, Czechia
Novartis Investigative Site
Prague, 12808, Czechia
Novartis Investigative Site
Saint-Cyr-sur-Loire, Indre Et Loire, 37540, France
Novartis Investigative Site
Lyon, Rhone, 69317, France
Novartis Investigative Site
Bordeaux, 33000, France
Novartis Investigative Site
Créteil, 94000, France
Novartis Investigative Site
Marseille, F 13008, France
Novartis Investigative Site
Montauban, 82000, France
Novartis Investigative Site
Nantes, 44093, France
Novartis Investigative Site
Paris, 75010, France
Novartis Investigative Site
Paris, 75015, France
Novartis Investigative Site
Rueil-Malmaison, 92500, France
Novartis Investigative Site
Freiburg im Breisgau, 79106, Germany
Novartis Investigative Site
Leipzig, 04103, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Jerusalem, 9112001, Israel
Novartis Investigative Site
Ramat Gan, 52621, Israel
Novartis Investigative Site
Ẕerifin, 6093000, Israel
Novartis Investigative Site
Perugia, PG, 06100, Italy
Novartis Investigative Site
Malacca, Melaka Malaysia, 75000, Malaysia
Novartis Investigative Site
Batu Caves, Selangor, 68100, Malaysia
Novartis Investigative Site
Shah Alam, Selangor, 40000, Malaysia
Novartis Investigative Site
's-Hertogenbosch, 5223 GZ, Netherlands
Novartis Investigative Site
Nijmegen, 6525 EX, Netherlands
Novartis Investigative Site
Porto, 4099-001, Portugal
Novartis Investigative Site
Vila Franca de Xira, 2600-009, Portugal
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620, South Korea
Novartis Investigative Site
Seoul, Seocho Gu, 06591, South Korea
Novartis Investigative Site
Busan, 49241, South Korea
Novartis Investigative Site
Daegu, 705703, South Korea
Novartis Investigative Site
Seoul, 05505, South Korea
Novartis Investigative Site
Seoul, 07301, South Korea
Novartis Investigative Site
Barcelona, Catalonia, 08022, Spain
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, 08190, Spain
Novartis Investigative Site
Pamplona, Navarre, 31008, Spain
Novartis Investigative Site
Burjassot, Valencia, 46100, Spain
Novartis Investigative Site
Barcelona, 08024, Spain
Novartis Investigative Site
Barcelona, 08025, Spain
Novartis Investigative Site
Córdoba, 14012, Spain
Novartis Investigative Site
Zaragoza, 50009, Spain
Novartis Investigative Site
Örebro, 701 85, Sweden
Novartis Investigative Site
Västerås, 72189, Sweden
Novartis Investigative Site
Binningen, 4102, Switzerland
Novartis Investigative Site
Taipei, 103616, Taiwan
Novartis Investigative Site
Taipei, 11217, Taiwan
Novartis Investigative Site
Taoyuan District, 33305, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 22, 2020
Study Start
December 16, 2020
Primary Completion
March 28, 2023
Study Completion
March 28, 2023
Last Updated
October 9, 2024
Results First Posted
April 4, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
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/.