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Neovascular Age-Related Macular DegenerationPhase 3SWIFTNCT04264819

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

A Phase 3 study testing RTH258/Brolucizumab in people with Neovascular Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 51 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
RTH258/Brolucizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
295 participants
Where
51 sitesFrance
Study dates
14 Dec 2020to 10 May 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

France51 sites

  • Novartis Investigative Site

    Aix-en-Provence, 13090

  • Novartis Investigative Site

    Angers, 49044

  • Novartis Investigative Site

    Avignon, 84000

  • Novartis Investigative Site

    Bobigny, Seine Saint Denis, 93009

  • Novartis Investigative Site

    Bordeaux, 33000

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Caen, 14000

  • Novartis Investigative Site

    Caen, 14033

  • Novartis Investigative Site

    Colmar, 68024

  • Novartis Investigative Site

    Créteil, 94000

  • Novartis Investigative Site

    Dijon, 21034

  • Novartis Investigative Site

    Grenoble, 38000

  • Novartis Investigative Site

    La Rochelle, 17019

  • Novartis Investigative Site

    La Valette-du-Var, 83160

  • Novartis Investigative Site

    Le Chesnay, 78157

  • Novartis Investigative Site

    Lille, 59000

  • Novartis Investigative Site

    Lyon, Rhone, 69317

  • Novartis Investigative Site

    Lyon, 69002

  • Novartis Investigative Site

    Lyon, 69275

  • Novartis Investigative Site

    Marseille, 13015

  • Novartis Investigative Site

    Marseille, F 13008

  • Novartis Investigative Site

    Melun, 77000

  • Novartis Investigative Site

    Montargis, 45200

  • Novartis Investigative Site

    Montauban, 82000

  • Novartis Investigative Site

    Montpellier, 34000

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Mulhouse, 68070

  • Novartis Investigative Site

    Nantes, 44093

  • Novartis Investigative Site

    Nantes, 44300

  • Novartis Investigative Site

    Nice, Cedex1, 06001

  • Novartis Investigative Site

    Paris, 75001

  • Novartis Investigative Site

    Paris, 75007

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative Site

    Paris, 75674

  • Novartis Investigative Site

    Perpignan, 66000

  • Novartis Investigative Site

    Plérin, 22190

  • Novartis Investigative Site

    Poitiers, 86000

  • Novartis Investigative Site

    Rennes, FRA, 35033

  • Novartis Investigative Site

    Rouen, 76100

  • Novartis Investigative Site

    Rueil-Malmaison, 92500

  • Novartis Investigative Site

    Saint-Cyr-sur-Loire, Indre Et Loire, 37540

  • Novartis Investigative Site

    Saint-Herblain, 44819

  • Novartis Investigative Site

    Saint-Jean, 31240

  • Novartis Investigative Site

    Saint-Jean-de-Védas, 34430

  • Novartis Investigative Site

    Saint-Martin-des-Champs, 50300

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Tours, 37000

  • Novartis Investigative Site

    Vincennes, 94300

Other trials in France

About this study

Official 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)

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.

Read the detailed description

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).

Being tested
RTH258/Brolucizumab
Keywords
Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD, diabetic macular edema, DME, neovascular age-related macular degeneration, nAMD, retinal vein occlusion, RVO, wetAMD, neovascular, choroidal neovascularization, disease control
Medical subject headings
Macular Degeneration, Vision Disorders, Geographic Atrophy, Wet Macular Degeneration, Retinal Vein Occlusion, Choroidal Neovascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTH258/BrolucizumabDrug

    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.

Study groups in NCT04264819
Study groupRoleWhat they receive
RTH258/BrolucizumabExperimentalThis is a single arm study in which all patients will be treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
Receives: Drug: RTH258/Brolucizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Week 16

Secondary outcomes (10)

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

    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.

    Measured: Week 48

  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

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

    Measured: Baseline, Weeks 4,8,16, 48

  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

    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.

    Measured: Baseline, Week 4, 8, 16, 48

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

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

    Measured: Baseline, Weeks 4, 8, 16, 48

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

    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.

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

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

    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.

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

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

    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.

    Measured: Baseline, Weeks 4, 8, 16, 48

  8. Summary of Treatment-emergent Adverse Events - Overall

    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.

    Measured: 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.

  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)

    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.

    Measured: 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.

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

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start14 Dec 2020
  3. Primary completion5 Oct 2022
  4. Study completion10 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm, open-label study
Masking
None (open label)
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04264819
Sponsor's protocol ID
CRTH258AFR03
Other IDs
2019-004145-33, 2019
Acronym
SWIFT
Status last verified
Sep 2024
First submitted
7 Feb 2020
Last updated
7 Nov 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Bodaghi B, Souied EH, Tadayoni R, Weber M, Ponthieux A, Kodjikian L. Detection and Management of Intraocular Inflammation after Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Oct;7(10):879-891. doi: 10.1016/j.oret.2023.06.009. Epub 2023 Jun 19.

    PubMed 37343623

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RTH258/Brolucizumab in people with Neovascular Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 51 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With no Disease Activity at Week 16 in the Study Eye (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04264819, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.

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