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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004767-53 | EudraCT Number |
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The purpose of this study was 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.
This study was a 52-week randomized, open-label, multi-center, two-arm study for pretreated patients with suboptimal anatomically controlled nAMD. Patients who consented were screened to evaluate eligibility. Eligible patients were randomized in a 1:1 ratio to one of the two treatment arms:
There were three periods in this study:
In both study arms, treatment intervals after the initiation phase were either 8 weeks or 12 weeks depending on disease activity status. More frequent injections, i.e., treatment intervals of < 8 weeks were not allowed after the initiation phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab 6 mg non-loading | Experimental | One initial injection followed by treatment every 12 weeks. |
|
| Brolucizumab 6 mg loading | Experimental | 3 x 4-weekly injections followed by treatment every 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab | Biological | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Week 40 to Week 52: LS Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Baseline, Week 40 to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Intervals Before and During the Study | Treatment interval distribution. Treatment interval during the study, within 24 weeks prior to baseline and interval between the last 2 injections in the study. In the loading arm, data from the loading period was excluded. | -24 Weeks, Baseline, Week 52 |
| Number of Patients With Prolonged Interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Regensburg | Bavaria | 93053 | Germany | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35188581 | Derived | Holz FG, Schmitz-Valckenberg S, Wolf A, Agostini H, Lorenz K, Pielen A, Feltgen N, Guthoff R, Quiering C, Clemens A, Jaeger K. 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. 2022 Aug;260(8):2695-2702. doi: 10.1007/s00417-022-05591-z. Epub 2022 Feb 21. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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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 ww.clinicalstudydatarequest.com.
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If both eyes were eligible as per the inclusion and exclusion criteria, the eye with the worse visual acuity should have been selected for study eye, unless the investigator deemed it more appropriate to select the eye with better visual acuity, based on medical reasons or local ethical requirements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brolucizumab 6 mg Loading | 3 x 4-weekly initial injections followed by an injection every 12 weeks |
| FG001 | Brolucizumab 6 mg Non-loading | One initial injection followed by treatment every 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2022 | Dec 19, 2024 |
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two arm, multicenter
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open-label
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Treatment interval distribution. Prolongation was calculated by comparing the mean treatment interval in last 24 weeks prior to first brolucizumab injection (a) with the mean of the average treatment interval during the study (loading phase excluded in the loading arm) and (b) with the last treatment interval during the study. Patients with only 1 injection during the treatment period were calculated as non-responders (no prolon-gation). |
| Baseline, Week 52 |
| Proportion of Patients Who Maintained on q12w Regimen. | Treatment interval distribution up to Week 52. Proportion of patients maintained on q12w treatment frequency in the two brolucizumab groups up to week 52. Patients who discontinued treatment before week 52 were rated as non-responders, i.e., as patients who did not maintain the q12w regimen. In the loading arm, the loading period up to week 12 was not considered in the analysis. | Up to week 52 |
| Distribution of Patients at Every 8 Weeks / Every 12 Weeks Intervals - Frequency of Switches in Treatment Intervals Between Baseline and Week 52 | Treatment interval distribution | Up to Week 52 |
| Mean Change in Best-corrected Visual Acuity | 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Baseline, Weeks 16 to 28, Week 52 |
| Number of Patients With Best-corrected Visual Acuity Improvements of >= 5, >= 10 and >= 15 Letters | 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Baseline, up to Week 52 |
| Number of Patients With Best-corrected Visual Acuity >= 69 Letters | 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Baseline, up to Week 52 |
| LS Mean Change in Best-corrected Visual Acuity From Baseline at Week 52 | 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Baseline, Week 52 |
| Change in Central Subfield Thickness From Baseline at Weeks 12, 16, 28 and 52 | Change in central subfield thickness was measured by Spectral domain optical coherence tomography. | Baseline, Weeks 12, 16, 28 and 52 |
| Absence of Intraretinal Fluid in the Central Subfield | Change in fluids was measured by Spectral domain optical coherence tomography. | Every 4 weeks from baseline up to Week 52 |
| Absence of Subretinal Fluid in the Central Subfield | Change in fluids was measured by Spectral domain optical coherence tomography. | Every 4 weeks from baseline up to Week 52 |
| Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield | Change in fluids was measured by Spectral domain optical coherence tomography. | Every 4 weeks from baseline up to Week 52 |
| Presence of Active Choroidal Neovascularization Leakage | Presence of active choroidal neovascularization leakage was measured by Fluorescein angiography. CNV = choroidal neovascularization; MNV = macular neovascularization | At Week 52 |
| Overview of TEAEs | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
| Ocular TEAEs in the Study Eye by Primary System Organ Class | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
| Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
| Non-ocular TEAEs - Total | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
| Ocular TEAEs in the Study Eye of Moderate or Severe Intensity | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
| Frankfurt am Main |
| Hesse |
| 60549 |
| Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Bonn | 53105 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Homburg | 66421 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Lübeck | 23538 | Germany |
| Novartis Investigative Site | Magdeburg | 39120 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Marburg | 35039 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Neubrandenburg | 17036 | Germany |
| Novartis Investigative Site | Ulm | 89075 | Germany |
| Novartis Investigative Site | Lausanne | CHE | 1000 | Switzerland |
| Novartis Investigative Site | Bern | 3007 | Switzerland |
| Novartis Investigative Site | Zurich | 8063 | Switzerland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab 6 mg Loading | 3 x 4-weekly initial injections followed by an injection every 12 weeks |
| BG001 | Brolucizumab 6 mg Non-loading | One initial injection followed by treatment every 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Week 40 to Week 52: LS Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | full analysis set - included all patients with a valid assessment without a protocol deviation with impact | Posted | Least Squares Mean | Standard Error | Letters read | Baseline, Week 40 to Week 52 |
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| Secondary | Treatment Intervals Before and During the Study | Treatment interval distribution. Treatment interval during the study, within 24 weeks prior to baseline and interval between the last 2 injections in the study. In the loading arm, data from the loading period was excluded. | full analysis set | Posted | Median | Full Range | days | -24 Weeks, Baseline, Week 52 |
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| Secondary | Number of Patients With Prolonged Interval | Treatment interval distribution. Prolongation was calculated by comparing the mean treatment interval in last 24 weeks prior to first brolucizumab injection (a) with the mean of the average treatment interval during the study (loading phase excluded in the loading arm) and (b) with the last treatment interval during the study. Patients with only 1 injection during the treatment period were calculated as non-responders (no prolon-gation). | full analysis set - included all patients with a valid assessment without a protocol deviation with impact | Posted | Count of Participants | Participants | Baseline, Week 52 |
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| Secondary | Proportion of Patients Who Maintained on q12w Regimen. | Treatment interval distribution up to Week 52. Proportion of patients maintained on q12w treatment frequency in the two brolucizumab groups up to week 52. Patients who discontinued treatment before week 52 were rated as non-responders, i.e., as patients who did not maintain the q12w regimen. In the loading arm, the loading period up to week 12 was not considered in the analysis. | full analysis set | Posted | Count of Participants | Participants | Up to week 52 |
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| Secondary | Distribution of Patients at Every 8 Weeks / Every 12 Weeks Intervals - Frequency of Switches in Treatment Intervals Between Baseline and Week 52 | Treatment interval distribution | full analysis set | Posted | Count of Participants | Participants | Up to Week 52 |
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| Secondary | Mean Change in Best-corrected Visual Acuity | 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | full analysis set | Posted | Mean | Standard Deviation | Letters read | Baseline, Weeks 16 to 28, Week 52 |
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| Secondary | Number of Patients With Best-corrected Visual Acuity Improvements of >= 5, >= 10 and >= 15 Letters | 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | full analysis set | Posted | Count of Participants | Participants | Baseline, up to Week 52 |
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| Secondary | Number of Patients With Best-corrected Visual Acuity >= 69 Letters | 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | full analysis set | Posted | Count of Participants | Participants | Baseline, up to Week 52 |
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| Secondary | LS Mean Change in Best-corrected Visual Acuity From Baseline at Week 52 | 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. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | full analysis set - included all patients with a valid assessment without a protocol deviation with impact | Posted | Least Squares Mean | Standard Error | Letters read | Baseline, Week 52 |
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| Secondary | Change in Central Subfield Thickness From Baseline at Weeks 12, 16, 28 and 52 | Change in central subfield thickness was measured by Spectral domain optical coherence tomography. | full analysis set | Posted | Median | Full Range | µm | Baseline, Weeks 12, 16, 28 and 52 |
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| Secondary | Absence of Intraretinal Fluid in the Central Subfield | Change in fluids was measured by Spectral domain optical coherence tomography. | full analysis set | Posted | Count of Participants | Participants | Every 4 weeks from baseline up to Week 52 |
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| Secondary | Absence of Subretinal Fluid in the Central Subfield | Change in fluids was measured by Spectral domain optical coherence tomography. | full analysis set | Posted | Count of Participants | Participants | Every 4 weeks from baseline up to Week 52 |
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| Secondary | Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield | Change in fluids was measured by Spectral domain optical coherence tomography. | full analysis set | Posted | Count of Participants | Participants | Every 4 weeks from baseline up to Week 52 |
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| Secondary | Presence of Active Choroidal Neovascularization Leakage | Presence of active choroidal neovascularization leakage was measured by Fluorescein angiography. CNV = choroidal neovascularization; MNV = macular neovascularization | full analysis set | Posted | Count of Participants | Participants | At Week 52 |
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| Secondary | Overview of TEAEs | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | safety analysis set | Posted | Count of Participants | Participants | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
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| Secondary | Ocular TEAEs in the Study Eye by Primary System Organ Class | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | safety analysis set | Posted | Count of Participants | Participants | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
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| Secondary | Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | safety analysis set | Posted | Count of Participants | Participants | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
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| Secondary | Non-ocular TEAEs - Total | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | safety analysis set | Posted | Count of Participants | Participants | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
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| Secondary | Ocular TEAEs in the Study Eye of Moderate or Severe Intensity | 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 subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. | safety analysis set | Posted | Count of Participants | Participants | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks. |
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| Post-Hoc | All Collected Deaths | On-treatment deaths are reported from first dose of study treatment until end of study treatment plus 30 days after last treatment, up to a maximum timeframe of approximately 52 weeks. Post-treatment death data are reported from day 31 after last treatment to end of study (Week 52). | safety analysis set | Posted | Count of Participants | Participants | Fatality data are reported from first dose of study treatment until approximately Week 52. |
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Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brolucizumab 6 mg Loading | 3 x 4-weekly initial injections followed by an injection every 12 weeks | 0 | 25 | 5 | 25 | 23 | 25 |
| EG001 | Brolucizumab 6 mg Non-loading | One initial injection followed by treatment every 12 weeks | 1 | 27 | 6 | 27 | 26 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye inflammation- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Iridocyclitis- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal haemorrhage- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal neovascularisation- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal vasculitis- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Visual acuity reduced- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Endophthalmitis- Study Eye | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Intraocular pressure increased- Study Eye | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Chromophobe renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Ballismus | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber cell- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Blepharitis- Bilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cataract- Bilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cataract- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Chalazion- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Conjunctival hyperaemia- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Conjunctival irritation- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Conjunctivitis allergic- Bilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Corneal epithelial microcysts- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Corneal erosion- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Detachment of retinal pigment epithelium- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dry eye- Bilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eczema eyelids- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eczema eyelids- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Episcleritis- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eye inflammation- Bilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eye inflammation- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eye irritation- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eye pain- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eye ulcer- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Foreign body sensation in eyes- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Macular oedema- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Macular oedema- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Ocular hyperaemia- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Posterior capsule opacification- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal aneurysm- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal aneurysm- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal cyst- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal exudates- Bilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal exudates- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal haemorrhage- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal oedema- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal oedema- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinal vasculitis- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retinopathy hypertensive | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Scleritis- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Subretinal fibrosis- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Subretinal fluid- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Subretinal fluid- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vision blurred- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Visual acuity reduced- Bilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Visual acuity reduced- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Visual acuity reduced- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vitreal cells- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vitreous detachment- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vitreous floaters- Bilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vitreous floaters- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vitreous haemorrhage- Fellow Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vitreous opacities- Study Eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Application site wound | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Injection site pain- Study Eye | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Retention cyst- Fellow Eye | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Conjunctivitis- Study Eye | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Hordeolum- Study Eye | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Expired product administered- Study Eye | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Intra-ocular injection complication- Fellow Eye | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Intra-ocular injection complication- Study Eye | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Intraocular pressure increased- Fellow Eye | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Intraocular pressure increased- Study Eye | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Vital dye staining cornea present- Study Eye | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Blepharal papilloma- Fellow Eye | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2024 | Dec 19, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| D014786 | Vision Disorders |
| D057092 | Geographic Atrophy |
| D057135 | Wet Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D015785 | Eye Diseases, Hereditary |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Week 48 |
|
| Week 52 |
|
| MMRM model |
| Difference |
| -4.15 |
| Standard Error of the Mean |
| 2.30 |
| 2-Sided |
| 95 |
| -8.78 |
| -0.48 |
| Other |
Analysis was purely descriptive. |
| Week 48 | MMRM model | Difference | -5.35 | Standard Error of the Mean | 2.38 | 2-Sided | 95 | -10.13 | -0.58 | Other | Analysis was purely descriptive. |
| Week 52 | MMRM model | Difference | -4.19 | Standard Error of the Mean | 2.28 | 2-Sided | 95 | -8.77 | 0.39 | Other | Analysis was purely descriptive. |
| Mean of Week 40 to Week 52 | MMRM model | Difference | -4.36 | Standard Error of the Mean | 2.09 | 2-Sided | 95 | -8.56 | -0.16 | Other | Analysis was purely descriptive. |
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