Evidence map›Paper›PMID 35188581›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2022

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.

F G Holz, Steffen Schmitz-Valckenberg, A Wolf, H Agostini, K Lorenz, A Pielen, N Feltgen, R Guthoff, C Quiering, A Clemens and 1 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04679935 (A 52-week, Two Arm, Randomized, Open-label, Multicenter Study Assessing the Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens for Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04679935 phase4completednot on this map

A 52-week, Two Arm, Randomized, Open-label, Multicenter Study Assessing the Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens for Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration

TypeinterventionalSponsorNovartis PharmaceuticalsRan2021 to 2024Enrolled52ConditionsAge-related Macular DegenerationArmsBrolucizumab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Short-term outcomes of intravitreal faricimab for refractory neovascular age-related macular degeneration.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Article
  4. Article
  5. Intravitreal faricimab for neovascular age-related macular degeneration previously treated with traditional anti-VEGF compounds: a real-world prospective study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Article
  6. Observational
  7. Review
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 3 countries.

F G HolzDepartment of Ophthalmology and GRADE Reading Center, University of Bonn, Bonn, Germany.
Steffen Schmitz-ValckenbergDepartment of Ophthalmology and GRADE Reading Center, University of Bonn, Bonn, Germany. steffen.valckenberg@utah.edu.ORCID http://orcid.org/0000-0003-3358-9942
A WolfDepartment of Ophthalmology, University of Ulm, Ulm, Germany.
H AgostiniEye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
K LorenzDepartment of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
A PielenUniversity Eye Hospital, Medizinische Hochschule Hannover, Hannover, Germany.
N FeltgenEye Center, Faculty of Medicine, University of Goettingen, Goettingen, Germany.
R GuthoffEye Hospital, Faculty of Medicine, University of Duesseldorf, Duesseldorf, Germany.
C QuieringNovartis Pharma GmbH, Nuernberg, Germany.
A ClemensNovartis Pharma AG, Basel, Switzerland.
K JaegerNovartis Pharma GmbH, Nuernberg, Germany.
Novartis (Germany) · DEUniversity of Bonn · DEHeinrich Heine University Düsseldorf · DEJohannes Gutenberg University Mainz · DEMedizinische Hochschule Hannover · DENovartis (Switzerland) · CHUniversität Ulm · DEUniversity of Freiburg · DEUniversity of Göttingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment 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.

methodsFALCON 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 1:1 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.

resultsFALCON 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.

conclusionsThe 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 registrationClinicaltrials.gov: NCT04679935, date of registration-22-Dec 2020; EUDRACT number: 2019-004763-53, date of registration-03 Dec 2019.

Indexed as

Macular DegenerationWet Macular DegenerationAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedHumansInfant, NewbornIntravitreal InjectionsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTreatment OutcomeVisual AcuityAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedbrolucizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAnti-VEGFBrolucizumabNeovascular age-related macular degenerationSwitch

Identifiers

PMID35188581
PMCPMC9325853
OpenAlexW4212954922

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.