Skip to main content
OpenTrials
Completed

NCT Number: NCT04264819

Study of Brolucizumab in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration

Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neovascular Age-related Macular Degeneration Cardiovascular Diseases Choroid Diseases Choroidal Neovascularization Embolism and Thrombosis Eye Diseases Geographic Atrophy Macular Degeneration Metaplasia Neovascularization, Pathologic Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Sensation Disorders Signs and Symptoms Thrombosis Uveal Diseases Vascular Diseases Venous Thrombosis Vision Disorders Wet Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Nice, Cedex1, France

Loading trial locations.

About this study

This is a prospective, single-arm, open-label, multicenter study to evaluate the efficacy and safety of brolucizumab 6 mg in pretreated suboptimal anatomically controlled patients with neovascular age-related macular degeneration (nAMD).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must provide written informed consent before any study-related procedures are performed.
  • Patients must be 50 years of age or older at Screening/Baseline.

Study eye:

  • Active CNV lesions secondary to nAMD diagnosed < 18 months prior to Screening/Baseline that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by FA and sequelae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub RPE hemorrhage, blocked fluorescence, or macular edema.
  • Previous treatment with only one licensed anti-VEGF drug (i.e. Lucentis®, Eylea®) with a ≥ Q4 and ≤ Q8 treatment (treatment interval of 26 to 62 days inclusive) with licensed anti-VEGF (a minimal washout period of at least 4 weeks / 26 days is required). Patients must have received at least 3 injections of this anti-VEGF in the 6 months prior to Screening/Baseline.
  • Presence of residual fluid (IRF or SRF that affects the central subfield under, as seen by OCT)
  • BCVA score must be ≤ 83 and ≥ 38 letters at an initial testing distance of 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at Screening/Baseline.

Exclusion criteria

Ocular conditions

  • Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis), in either eye at Screening/Baseline.
  • Presence of amblyopia, amaurosis, or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Screening/Baseline (except when due to conditions whose surgery may improve visual acuity, e.g. cataract).
  • Medical history of intraocular inflammation and/or retinal vascular occlusion within 12 months prior to Screening/Baseline

Study eye

  • Poor quality of OCT image at Screening/Baseline.
  • Atrophy or fibrosis involving the center of the fovea in the study eye, as assessed by CFP and fundus autofluorescence (FAF).
  • The total area of fibrosis or subretinal blood affecting the foveal center point comprising ≥ 50% of the lesion area in the study eye.
  • Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product.
  • Structural damage within 0.5 disc diameter of the center of the macula in the study eye, e.g. vitreomacular traction, epiretinal membrane, RPE rip/tear scar, laser burn, at the time of Screening/Baseline that in the Investigator's opinion could preclude visual function improvement with treatment.
  • Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Screening/Baseline.
  • Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to the Investigator's judgment, at Screening/Baseline.
  • Aphakia and/or absence of the posterior capsule in the study eye. Ocular treatments (study eye)
  • Patient has received any investigational treatment for nAMD (other than vitamin supplements) in the study eye at any time.
  • Previous use of intraocular or periocular of corticosteroids in the study eye within the 6 month period prior to Screening/Baseline.
  • Previous penetrating keratoplasty or vitrectomy at any time prior to Screening/Baseline.
  • History or evidence of the following in the study eye within the 90-day period prior to Screening/Baseline:
  • Intraocular or refractive surgery.
  • Previous panretinal and peripheral laser photocoagulation.
  • Previous macular surgery or other intraocular surgical intervention
  • Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline.
  • Previous treatment with investigational drugs.

Treatment and study plan

RTH258/Brolucizumab

Drug

Brolucizumab is a new generation of anti-VEGF (vascular endothelial growth factor). All patients will be treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by Treat-to-Control regimen up to Week 44/46.

Primary outcomes

  1. Number of Patients With no Disease Activity at Week 16 in the Study Eye

    Time frame: Week 16

    Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:

    • Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity
    • Any significant increase in central retinal thickness (CRT)
    • Retinal hemorrhage
    • Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed)
    • Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.

Secondary outcomes

  1. Number of Patients With no Disease Activity at Week 48 in the Study Eye

    Time frame: Week 48

    Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:

    • Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity
    • Any significant increase in central retinal thickness (CRT)
    • Retinal hemorrhage
    • Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed)
    • Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.

  2. Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye

    Time frame: Baseline, Weeks 4,8,16, 48

    Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

  3. Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye

    Time frame: Baseline, Week 4, 8, 16, 48

    Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

    At week 8, for 1 patient, the fluid assessment was performed, but result is unknown; at week 16, for 1 patient, the fluid assessment was performed, but result is unknown; at week 48, for 2 patients, the fluid assessment was performed, but result is unknown.

  4. Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye

    Time frame: Baseline, Weeks 4, 8, 16, 48

    Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

  5. Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye

    Time frame: Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks

    Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:

    • Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity
    • Any significant increase in central retinal thickness (CRT)
    • Retinal hemorrhage
    • Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed)
    • Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.

  6. Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye

    Time frame: Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks

    Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:

    • Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity
    • Any significant increase in central retinal thickness (CRT)
    • Retinal hemorrhage
    • Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed)
    • Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.

  7. Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye

    Time frame: Baseline, Weeks 4, 8, 16, 48

    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

    Visual Function of the study eye was assessed using the ETDRS protocol.

    Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.

  8. Summary of Treatment-emergent Adverse Events - Overall

    Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.

    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.

  9. Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)

    Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.

    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.

  10. Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Non-ocular

    Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.

    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A One-year, Single-arm, Open-label, Multicenter Study Assessing the Effect of Brolucizumab on Disease Control in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)

Acronym: SWIFT

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 11, 2020
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.