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Monoclonal Antibodies

brolucizumab for Age-Related Macular Degeneration (TALON Ext Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

TALON Ext Trial Summary

This trial is to study the long-term effects of the drug brolucizumab on patients with neovascular age-related macular degeneration. The study will last for 56 weeks and will follow patients who have already completed the CRTH258A2303 study.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

TALON Ext Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye
Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye
Secondary outcome measures
Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye
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
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
+4 more

Side effects data

From 2023 Phase 3 trial • 248 Patients • NCT04597632
4%
Neovascular age-related macular degeneration - Fellow eye
4%
Cataract - Study eye
4%
COVID-19
3%
Fall
3%
Nasopharyngitis
3%
Cataract - Fellow eye
2%
Eye pain - Study eye
2%
Intraocular pressure increased - Study eye
2%
Visual acuity reduced - Study eye
2%
Basal cell carcinoma
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brolucizumab 6mg

TALON Ext Trial Design

1Treatment groups
Experimental Treatment
Group I: brolucizumab 6 mgExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
brolucizumab
2021
Completed Phase 3
~750

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,865 Previous Clinical Trials
4,199,037 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has brolucizumab acquired approval from the Food and Drug Administration?

"Brolucizumab's safety is supported by Phase 4 trial data, thus receiving the highest score of 3."

Answered by AI

Are there any remaining openings for individuals to participate in this clinical trial?

"This experiment is currently recruiting candidates, with the initial posting dating back to December 16th 2020. The details have been updated as recently as September 15th 2022 on clinicaltrials.gov."

Answered by AI

Has brolucizumab been previously tested in other controlled experiments?

"Currently, 10 medical studies involving brolucizumab are active, 5 of which have reached Phase 3. Notably, Porto and Cataluna each host a trial for this drug while there are 360 other locations all over the world running trials as well."

Answered by AI

What is the aggregate enrollment figure for this clinical trial?

"Indeed, data found on clinicaltrials.gov clearly states that this medical experiment is currently open for enrolment. The trial was initially announced on December 16th 2020 and the most recent update can be dated back to September 15th 2022. A total of 255 participants are required from one single testing site."

Answered by AI

What is the primary aim of this experiment?

"This trial will evaluate brolucizumab's efficacy over a Baseline, 52 and 56 week duration. Primary outcomes of the study include anatomical changes in intraretinal fluid and/or subretinal fluid, as well as alterations to visual acuity. Secondary objectives focus on assessing ocular and non-ocular Adverse Events (AEs) up to Week 56."

Answered by AI

Does this clinical trial mark a new milestone in its field of research?

"Novartis Pharmaceuticals initially sponsored the first research of brolucizumab in 2019, which involved 263 patients. After successful Phase 3 drug approval following that study, there are now 10 active trials for this medication across 146 cities and 29 countries."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04597632.
~56 spots leftby May 2025
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