An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regime… (NCT04597632) | Clinical Trial Compass
CompletedPhase 3
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
United States, Australia, Belgium248 participantsStarted 2020-12-16
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an extension study for people who already completed the TALON trial, can you tell me whether my treatment history or current disease status would make this kind of long-interval treat-to-control approach with brolucizumab something worth considering for me?
2The trial measured how long patients could go between injections without showing disease activity — what does that kind of outcome actually mean for day-to-day vision and quality of life, and how does it compare to what I might expect from standard anti-VEGF treatments I could receive now?
3Brolucizumab has had some safety signals in earlier studies, including rare cases of eye inflammation — given that this Phase 3 extension study is now completed, has your review of the data changed how you think about its risk-benefit profile compared to other options for wet AMD?
4Since this trial is already completed and I wouldn't be enrolling, is the data from this study available, and could it inform whether brolucizumab in a treat-to-control regimen might be a good fit for managing my condition going forward?
5The study tracked vision changes measured as BCVA at weeks 52 and 56 — based on what was found, do you think extending injection intervals while maintaining vision is a realistic goal for someone at my stage of neovascular AMD?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye
Timeframe: Up to Week 56
2
Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye
Timeframe: Extension study baseline, average of Week 52 and Week 56