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FALCON: Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04679935
Collaborator
(none)
490
Enrollment
33
Locations
2
Arms
34.6
Anticipated Duration (Months)
14.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of two different brolucizumab 6 mg dosing regimens in patients with visual impairment due to age-related macular degeneration (AMD) who have previously received anti-VEGF (vascular endothelial growth factor) treatment.

Condition or Disease Intervention/Treatment Phase
  • Biological: Brolucizumab
 Phase 4

Detailed Description

The study is a 52-week, two arm, randomized, open-label, multicenter study in patients with suboptimal anatomically controlled neovascular age-related macular degeneration. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria. Afterwards, patients will be randomized in a 1:1 ratio to one of the two treatment arms and attend 15 planned visits. Subjects in the loading arm will receive 3x monthly loading doses followed by treatment every 12 weeks. Subjects in the non-loading arm receive one initial injection followed by treatment every 12 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
490 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two arm, multicentertwo arm, multicenter
Masking:
None (Open Label)
Masking Description:
open-label
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 13, 2021
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brolucizumab 6 mg non-loading

One initial injection followed by treatment every 12 weeks.

Biological: Brolucizumab
Intravitreal injection
Other Names:
  • RTH258

    		•
    Experimental: Brolucizumab 6 mg loading

    3 x 4-weekly injections followed by treatment every 12 weeks.

    Biological: Brolucizumab
    Intravitreal injection
    Other Names:
  • RTH258

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean change in best-corrected visual acuity [Baseline, Week 40 to Week 52]

      Visual acuity test

    Secondary Outcome Measures

    1. Mean treatment interval [-24 Weeks, Baseline, Week 52]

      Treatment interval distribution

    2. Rate of patients with prolonged interval [-24 Weeks, Baseline, Week 52]

      Treatment interval distribution

    3. Proportion of patients maintained at a every 12 weeks interval [every 12 weeks up to week 52]

      Treatment interval distribution

    4. Distribution of patients at every 8 weeks/ every 12 weeks intervals [Baseline and every 8 or 12 weeks, up tp Week 52]

      Treatment interval distribution

    5. Mean change in best-corrected visual acuity [Baseline, Week 52]

      Visual acuity test

    6. Proportions of patients with best-corrected visual acuity improvements of >= 5, >= 10 and >= 15 letters [Baseline, Week 52]

      Visual acuity test

    7. Proportion of patients with best-corrected visual acuity >= 69 letters [At Week 52]

      Visual acuity test

    8. Mean change in best-corrected visual acuity [Baseline, Week 16 to Week 28]

      Visual acuity test

    9. Change in central subfield thickness [Baseline, Week 52]

      Spectral domain optical coherence tomography

    10. Absence of intraretinal fluid, subretinal fluid, and sub-retinal pigment epithelium fluid in the central subfield [Up to Week 52]

      Spectral domain optical coherence tomography

    11. Presence of active choroidal neovascularization leakage [At Week 52]

      Fluorescein angiography

    12. Incidence of ocular and non-ocular adverse events [Up to Week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed informed consent must be obtained prior to participation in the study

    • Male or female patients ≥ 50 years of age at screening

    • Active choroidal neovascularization (CNV) secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema (intraretinal fluid (IRF) and/or subretinal fluid (SRF) and/or sub-retinal pigment epithelium (sub-RPE) fluid that affects the central subfield, as seen by spectral domain optical coherence tomography (SD-OCT)) at screening, as confirmed by central reading center (study eye). If active CNV according to the above explained activity criteria is not detectable in screening image data (no IRF and no SRF), presence of residual and/or recurrent fluid (IRF and / or SRF) within the last 6 months before baseline visit is also considered eligible. In this case, historical images must be submitted for analysis by the central reading center.

    • Pretreatment with any anti-VEGF drug for a maximum of five years (60 months). Patients should have shown functional and/or anatomical treatment response to the pretreatment(s), prior to participating in this study.

    • The treatment initiation phase with the current anti-VEGF must have been completed for at least 6 months with continuous treatment in a ≥ q4w to ≤ q12w injection interval (±2-day window, i.e., 26 to 86 days inclusive) before the baseline visit. At least 4 weeks (minimum 26 days) must have passed between the last anti-VEGF pretreatment and baseline.

    • Best-corrected visual acuity (BCVA) score between 83 and 38 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)

    Exclusion Criteria:

    • Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the 52-week study period, atrophy or fibrosis at the center of the fovea as confirmed by central reading center or structural damage of the fovea (study eye)

    • Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)

    • Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgement, at screening or baseline (study eye)

    • Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract)

    • Ocular treatments: treatment with anti-VEGF drugs for > 5 years in the study eye, pretreatment with brolucizumab at any time in the study eye, previous treatment with investigational drugs in the last 6 months, intraocular or periocular steroids at any time, macular laser photocoagulation or photodynamic therapy at any time, peripheral laser photocoagulation within 3 months prior to baseline, intraocular surgery within 3 months prior to baseline, vitreoretinal surgery at any time, aphakia with the absence of posterior capsule (study eye)

    • Stroke or myocardial infarction during the 6 month period prior to baseline

    • Systemic anti-VEGF therapy during the 3-month period prior to baseline

    Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Regensburg Bavaria Germany 93053
    2 Novartis Investigative Site Frankfurt Main Hessen Germany 60549
    3 Novartis Investigative Site Augsburg Germany 86179
    4 Novartis Investigative Site Berlin Germany 10713
    5 Novartis Investigative Site Berlin Germany 13353
    6 Novartis Investigative Site Bonn Germany 53105
    7 Novartis Investigative Site Darmstadt Germany 64297
    8 Novartis Investigative Site Dresden Germany 01067
    9 Novartis Investigative Site Dresden Germany 01307
    10 Novartis Investigative Site Duesseldorf Germany 40225
    11 Novartis Investigative Site Gottingen Germany 37075
    12 Novartis Investigative Site Hannover Germany 30625
    13 Novartis Investigative Site Heidelberg Germany 69120
    14 Novartis Investigative Site Homburg Germany 66421
    15 Novartis Investigative Site Koeln Germany 50924
    16 Novartis Investigative Site Leipzig Germany 04103
    17 Novartis Investigative Site Ludwigshafen Germany 67063
    18 Novartis Investigative Site Luebeck Germany 23538
    19 Novartis Investigative Site Magdeburg Germany 39120
    20 Novartis Investigative Site Mainz Germany 55131
    21 Novartis Investigative Site Marburg Germany 35039
    22 Novartis Investigative Site Muenchen Germany 81377
    23 Novartis Investigative Site Muenster Germany 48149
    24 Novartis Investigative Site Neubrandenburg Germany 17036
    25 Novartis Investigative Site Ulm Germany 89075
    26 Novartis Investigative Site Wuerzburg Germany 97080
    27 Novartis Investigative Site Lausanne CHE Switzerland 1000
    28 Novartis Investigative Site Aarau Switzerland 5001
    29 Novartis Investigative Site Basel Switzerland 4056
    30 Novartis Investigative Site Bern Switzerland 3012
    31 Novartis Investigative Site Lausanne Switzerland 1006
    32 Novartis Investigative Site Zuerich Switzerland 8063
    33 Novartis Investigative Site Zurich Switzerland 8091

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04679935
    Other Study ID Numbers:
    • CRTH258ADE01
    • 2019-004767-53
    First Posted:
    Dec 22, 2020
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    AMD, nAMD, wet AMD, RTH258, brolucizumab, switch
    Additional relevant MeSH terms:
    Macular Degeneration
    Eye Diseases
    Wet Macular Degeneration
    Retinal Diseases
    Retinal Degeneration

    Study Results

    No Results Posted as of Aug 1, 2022