A randomized, open-label, multicenter study of switching to brolucizumab with or without a loading dose for patients with suboptimal anatomically controlled neovascular age-related macular degeneration-the FALCON study.
Graefes Arch Clin Exp Ophthalmol
; 260(8): 2695-2702, 2022 Aug.
Article
in En
| MEDLINE
| ID: mdl-35188581
ABSTRACT
BACKGROUND:
Treatment initiation with brolucizumab, a new potent anti-vascular endothelial growth factor (VEGF) agent, is typically performed with three monthly injections (loading dose) and has been well studied in treatment-naïve patients. However, no clinical data are available yet on whether or not anti-VEGF pretreated patients also benefit from a loading dose. In the clinical setting, different heterogeneous treatment patterns are used as no clinical trial has addressed this so far in a head-to-head comparison. Therefore, the FALCON study is investigating whether patients with unsatisfactory response to previous anti-VEGF treatments benefit from a loading dose at the switch to brolucizumab treatment.METHODS:
FALCON is a 52-week, two-arm, randomized, open-label, multicenter, multinational study in patients with residually active neovascular age-related macular degeneration (nAMD) who will be randomized 11 and started with brolucizumab 6 mg loading (three monthly loading doses) or brolucizumab 6 mg non-loading (one initial injection) and consecutive treatment every 12 weeks, respectively. The primary objective is to demonstrate non-inferiority of the non-loading vs. loading arm in mean change of best-corrected visual acuity (BCVA) from baseline to the mean value at week 40 to week 52. Secondary objectives include the assessment of anatomical outcomes, treatment intervals, safety and tolerability.RESULTS:
FALCON will be the first study to assess treatment initiation with an anti-VEGF agent in a switch situation with or without loading dose in patients with nAMD.CONCLUSIONS:
The results will support the optimization of treatment of patients with previous unsatisfactory anti-VEGF response. Therefore, we expect to see an impact on current clinical practice which has been established for more than a decade. TRIAL REGISTRATION Clinicaltrials.gov NCT04679935, date of registration-22-Dec 2020; EUDRACT number 2019-004763-53, date of registration-03 Dec 2019.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Wet Macular Degeneration
/
Macular Degeneration
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Humans
/
Newborn
Language:
En
Journal:
Graefes Arch Clin Exp Ophthalmol
Year:
2022
Document type:
Article
Affiliation country:
Germany
Publication country:
ALEMANHA
/
ALEMANIA
/
DE
/
DEUSTCHLAND
/
GERMANY