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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002452-20 | EudraCT Number |
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The purpose of this study was to identify innovative early imaging parameters as predictors of the long-term clinical response to brolucizumab in terms of fluid resolution in patients with wet Age-related Macular Degeneration (wAMD) to evaluate their potential in supporting the choice of treatment regimen (q12w or q8w).
The study was a one-year, open-label, single arm, multicenter, phase IV study in patients with wAMD. The study planned to enroll approximately 263 (male and female) patients aged 50 years or older with untreated active subfoveal choroidal neovascularization (CNV) secondary to wAMD in the study eye from approximately 30 centers in Italy. The duration of the study treatment for enrolled patients was a maximum of 48 weeks, consisting of 8 weeks of three monthly loading doses and 40 weeks of maintenance regimen period (q8w or q12w) according to disease activity assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab 6 mg | Experimental | Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab | Drug | 120 mg/ml solution for intravitreal injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Classified as q12w Fluid-free or Not q12w Fluid-free | Early predictive factors of fluid-free response is defined as the absence of retinal fluid at Week 48 in patients with a stable q12w treatment regimen up to Week 48 after the loading phase, As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). q12w fluid-free: pts completing the treatment and the study maintaining a stable q12w regimen assigned at Wk 16 up to Wk 48 and without the presence of IRF and SRF at Wk 48. not q12w fluid-free:
| Up to Week 48 |
| Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Type 1 neovascularization arises when CNV proliferation occurs below the Retinal Pigment Epithelium (RPE) and corresponds to occult CNV with a poorly defined pattern of leakage on fluorescein angiography (FA). Type 2 neovascularization refers to CNV proliferation above the RPE in the subretinal space and corresponds to classic CNV with intense fluorescein leakage. Type 3 neovascularization (or retinal angiomatous proliferation [RAP]) occurs when retinal circulation is involved, with an anastomosis between the choroidal and retinal circulations. Types 1-3 classification is a classification according to the type of anatomical lesion and is determined by multimodal imaging characteristics. Please note that by design, this is not a grading nor scores on a scale. PCV = Polypoidal Choroidal Vasculopathy | Baseline |
| Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as q12w Fluid-free |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD) The morphology of the Neovascularization (CNV) complex was evaluated qualitatively by assessing the presence/absence of branching vessels. The presence of tiny vessels branching from bigger vessels is indicative of an active CNV lesion. UNG/P = Ungradable due to pathology UNG/Q = Ungradable due to Quality |
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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 | Ancona | AN | 60126 | Italy | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40833455 | Derived | Lupidi M, Bandello F, Vujosevic S, Parravano M, Bacherini D, Minnella AM, Giansanti F, Ascardi C, Staurenghi G. Multimodal Imaging to Assess Disease Activity and Predict Fluid Resolution in Patients with wAMD Treated with Brolucizumab: The IMAGINE Study. Ophthalmol Ther. 2025 Oct;14(10):2497-2510. doi: 10.1007/s40123-025-01229-5. Epub 2025 Aug 20. |
| 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 https://www.clinicalstudydatarequest.com.
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If both eyes were eligible as per the inclusion and exclusion criteria, only one eye was treated during the study, with the eye with the worse visual acuity (BCVA) at Baseline selected as the study eye. If both eyes had the same BCVA, the right eye was chosen as the study eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brolucizumab 6 mg | Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA). |
| 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 11, 2021 | Sep 18, 2024 |
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The study is a one-year, open-label, single arm, multicenter, phase IV study in patients with wAMD.
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As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Type 1 neovascularization arises when CNV proliferation occurs below the Retinal Pigment Epithelium (RPE) and corresponds to occult CNV with a poorly defined pattern of leakage on fluorescein angiography (FA). Type 2 neovascularization refers to CNV proliferation above the RPE in the subretinal space and corresponds to classic CNV with intense fluorescein leakage. Type 3 neovascularization (or retinal angiomatous proliferation [RAP]) occurs when retinal circulation is involved, with an anastomosis between the choroidal and retinal circulations. Types 1-3 classification is a classification according to the type of anatomical lesion and is determined by multimodal imaging characteristics. Please note that by design, this is not a grading nor scores on a scale. PCV = Polypoidal Choroidal Vasculopathy |
| Baseline |
| Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free.
| Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free.
| Baseline to Week 16 |
| Potential Predictor Factors of Fluid-free Response: Percentage Changes in Central Subfield Thickness (CST) From Baseline at Week 16 - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Mean (SD) was computed on the Safety Population within 'No' and 'Yes' groups according to q12w fluid free. | Baseline, Week 16 |
| Potential Predictor Factors of Fluid-free Response: Percentage Changes in Central Subfield Thickness (CST) From Baseline at Week 16 - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Mean (SD) was computed on the Safety Population within 'No' and 'Yes' groups according to q12w fluid free. | Baseline, Week 16 |
| Baseline, Week 16, Week 48 |
| Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Total CNV Lesion Area (mm*2) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The total Basal Choroidal Neovascularization (CNV) lesion area (mm^2) and greatest linear diameter of lesion (mm) are the parameters related to CNV flow size. | Baseline, Week 16, Week 48 |
| Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Choroidal Neovascularization (CNV) Vascular Density (%) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The Choroidal Neovascularization (CNV) vascular density (%) is calculated as a ratio of the area occupied by vessels and the total area of the lesion and multiplied by 100. | Baseline, Week 16, Week 48 |
| Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Lesion Greatest Linear Diameter (mm) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The total Basal Choroidal Neovascularization (CNV) lesion area (mm^2) and greatest linear diameter of lesion (mm) are the parameters related to CNV flow size. | Baseline, Week 16, Week 48 |
| Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the peripheral anastomotic arcades. The presence of peripheral anastomotic arcades at the vessel termini is indicative of an active CNV lesion. | Baseline, Week 16, Week 48 |
| Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the vascular loops. The presence of vascular loops is indicative of an active CNV lesion. | Baseline, Week 16, Week 48 |
| Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the dark halo. The presence of dark halo is considered a region of choriocapillaris alteration corresponding to local flow impairment and is indicative of an active CNV lesion. | Baseline, Week 16, Week 48 |
| Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD) | Baseline, Week 16, Week 48 |
| Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). The central retina thickness (CRT) evaluated in this study represents the average retinal thickness of the circular area within 1 mm diameter around the foveal center and was called Center Subfield Thickness (CST), also known as foveal thickness. | Baseline, Week 16, Week 48 |
| Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD) | Baseline, Week 16, Week 48 |
| Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). IRF is the fluid that accumulates within the neurosensory retina due to the disruption of the external limiting membrane (ELM)-photoreceptor complex in the outer retina by the active Choroidal Neovascularization (CNV) membrane. | Baseline, Week 16, Week 48 |
| Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). SRF is the fluid that commonly accumulates between the neurosensory retina and the retinal pigment epithelium (RPE) due to the profuse leakage from blood vessels of the Choroidal Neovascularization (CNV) complex. | Baseline, Week 16, Week 48 |
| Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). Sub-RPE fluid, i.e., the fluid that accumulates under the RPE, thus often leading to Pigment Epithelial Detachments (PEDs). | Baseline, Week 16, Week 48 |
| Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). SHRM, i.e., a poorly defined, medium-to-hyperreflective mass between the neurosensory layers and the sub retinal pigment epithelium (RPE) on SD-OCT, which is indicative of the neurovascular membrane, particularly in type II Choroidal Neovascularization (CNV) lesions, and of disciform scar formation | Baseline, Week 16, Week 48 |
| Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). ORT, i.e., branching tubular structures located in the outer nuclear layer of the retina, which seems to be indicative of a rearrangement of degenerating photoreceptors in a variety of retinal diseases, including wAMD. On SD-OCT, ORT appears as well-defined round or ovoid hyporeflective spaces with hyperreflective borders. | Baseline, Week 16, Week 48 |
| Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). Status of the ELM as an indicator of retinal integrity was evaluated focusing on ELM integrity loss in center 1 mm (i.e., considering the central 1 x 1-mm subfield). | Baseline, Week 16, Week 48 |
| Change in Best-corrected Visual Acuity (BCVA) From Baseline up to Week 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. Participants with a BCVA ETDRS letter score of >= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. | Baseline, Week 16, Week 48 |
| Number of Patients With Fluid Resolution of the Study Eye | Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Among patients with fluid present at Baseline, patients with fluid resolution were identified in case of absence of IRF and SRF and patients without fluid resolution were categorized in 'only IRF present', 'only SRF present', 'both IRF and SRF present' at each post-baseline timepoint. IRF = Intraretinal Fluid SRF = Subretinal Fluid | Week 16, Week 48 |
| Sustained Dryness of the Study Eye - Kaplan-Meier Estimates - Median Time to the Achievement of Sustained Dryness | Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Patients who achieved sustained dryness were identified considering those with fluid resolution for at least 2/3 consecutive visits. Median time to the achievement of sustained dryness was calculated by the Kaplan-Meier method. Sustained dryness of the study eye, is defined by the absence of IRF and SRF for at least 2 consecutive visits and for at least 3 consecutive visits. IRF = Intraretinal Fluid SRF = Subretinal Fluid | Up to Week 48 |
| Cumulative Incidence of Patients With Sustained Dryness of the Study Eye | Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Sustained dryness of the study eye, is defined by the absence of IRF and SRF for at least 2 consecutive visits and for at least 3 consecutive visits. IRF = Intraretinal Fluid SRF = Subretinal Fluid | Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
| Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 | Evaluate the reasons underlying the Investigators' choice of brolucizumab treatment regimen (q8w) BVCA=Best-Corrected Visual Acuity, CFP=Color Fundus Photography; CNV=Choroidal Neovascularization; FA=Fluorescein Angiography; ICGA=IndoCyanine Green Angiography; OCTA=Optical Coherence Tomography Angiography; SD-OCT=Spectral Domain Optical Coherence Tomography | Up to Week 16 |
| Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 | Evaluate the reasons underlying the Investigators' choice of brolucizumab treatment regimen (q12w) BVCA=Best-Corrected Visual Acuity, CFP=Color Fundus Photography; CNV=Choroidal Neovascularization; FA=Fluorescein Angiography; ICGA=IndoCyanine Green Angiography; OCTA=Optical Coherence Tomography Angiography; SD-OCT=Spectral Domain Optical Coherence Tomography | Up to Week 16 |
| Change in Hospital Anxiety and Depression Scale (HADS) Scores | Evaluate anxiety/depression in patients with wAMD treated with brolucizumab. The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale that generates ordinal data. Seven items relate to anxiety and seven relate to depression. This patient-reported outcome measure was specifically developed to avoid reliance on anxiety/depression aspects which are also common somatic symptoms of illness, such as fatigue and insomnia or hypersomnia. Calculations of scores: each item is rated on a 4-point scale. The HADS consists of two sub-scores: the HAD-A for anxiety and HAD-D for depression. Each sub-score ranges from 0 to 21 points: scores ≥11 indicate the presence of an anxious or depressive disorder, scores between 8-10 points are borderline abnormal, and scores ≤7 indicate that an anxious or depressive disorder is not present. | Up to Week 48 |
| Change in European Quality of Life-5D-5L (EQ-5D-5L) Scores | Evaluate quality of life in patients with wAMD treated with brolucizumab. The EQ-5D-5L is a standardized widely used instrument for measuring generic health status. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. i.e. no problems, slight problems, moderate problems, severe problems and extreme problems, corresponding to digit numbers ranging from 1 to 5. The EQ-5D-5L total score is determined through a Visual Analogue Scale (VAS) and ranges from 0 to 100 with higher scores indicative of a better health status. | Baseline, Week 48 |
| Treatment Emergent Adverse Events | 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 | AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks. |
| Ocular Treatment Emergent Adverse Events - 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 subject or clinical investigation subject | AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks. |
| Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) | 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 | AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks. |
| Acquaviva delle Fonti |
| BA |
| 70021 |
| Italy |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Cagliari | CA | 09124 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Milan | MI | 20100 | Italy |
| Novartis Investigative Site | Milan | MI | 20122 | Italy |
| Novartis Investigative Site | Milan | MI | 20123 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Roma | RM | 00133 | Italy |
| Novartis Investigative Site | Roma | RM | 00144 | Italy |
| Novartis Investigative Site | Roma | RM | 00168 | Italy |
| Novartis Investigative Site | Siena | SI | 53100 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Trieste | TS | 34129 | Italy |
| Novartis Investigative Site | Negrar | VR | 37024 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Naples | 80138 | Italy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab 6 mg | Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA). |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| 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 | |||||||||||||||||||||||||||
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| Primary | Number of Patients Classified as q12w Fluid-free or Not q12w Fluid-free | Early predictive factors of fluid-free response is defined as the absence of retinal fluid at Week 48 in patients with a stable q12w treatment regimen up to Week 48 after the loading phase, As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). q12w fluid-free: pts completing the treatment and the study maintaining a stable q12w regimen assigned at Wk 16 up to Wk 48 and without the presence of IRF and SRF at Wk 48. not q12w fluid-free:
| Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact. (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Up to Week 48 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Type 1 neovascularization arises when CNV proliferation occurs below the Retinal Pigment Epithelium (RPE) and corresponds to occult CNV with a poorly defined pattern of leakage on fluorescein angiography (FA). Type 2 neovascularization refers to CNV proliferation above the RPE in the subretinal space and corresponds to classic CNV with intense fluorescein leakage. Type 3 neovascularization (or retinal angiomatous proliferation [RAP]) occurs when retinal circulation is involved, with an anastomosis between the choroidal and retinal circulations. Types 1-3 classification is a classification according to the type of anatomical lesion and is determined by multimodal imaging characteristics. Please note that by design, this is not a grading nor scores on a scale. PCV = Polypoidal Choroidal Vasculopathy | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as not q12w fluid-free (N=93). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline |
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| Primary | Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Type 1 neovascularization arises when CNV proliferation occurs below the Retinal Pigment Epithelium (RPE) and corresponds to occult CNV with a poorly defined pattern of leakage on fluorescein angiography (FA). Type 2 neovascularization refers to CNV proliferation above the RPE in the subretinal space and corresponds to classic CNV with intense fluorescein leakage. Type 3 neovascularization (or retinal angiomatous proliferation [RAP]) occurs when retinal circulation is involved, with an anastomosis between the choroidal and retinal circulations. Types 1-3 classification is a classification according to the type of anatomical lesion and is determined by multimodal imaging characteristics. Please note that by design, this is not a grading nor scores on a scale. PCV = Polypoidal Choroidal Vasculopathy | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline |
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| Primary | Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as not q12w fluid-free (N=93). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as not q12w fluid-free (N=93). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as not q12w fluid-free (N=93). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as not q12w fluid-free (N=93). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No'). | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free.
| Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as not q12w fluid-free (N=93). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free.
| Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.) | Posted | Count of Participants | Participants | Baseline to Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Percentage Changes in Central Subfield Thickness (CST) From Baseline at Week 16 - Patients Classified as q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Mean (SD) was computed on the Safety Population within 'No' and 'Yes' groups according to q12w fluid free. | Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.) | Posted | Mean | Standard Deviation | Percentage change | Baseline, Week 16 |
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| Primary | Potential Predictor Factors of Fluid-free Response: Percentage Changes in Central Subfield Thickness (CST) From Baseline at Week 16 - Patients Classified as Not q12w Fluid-free | As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Mean (SD) was computed on the Safety Population within 'No' and 'Yes' groups according to q12w fluid free. | Full Analysis Set - includes all patients who received at least one dose of the study drug and who were classified as not q12w fluid-free and with a valid measurement without a protocol deviation with impact. (N=92). (Excludes patients with protocol deviations.) | Posted | Mean | Standard Deviation | Percentage change | Baseline, Week 16 |
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| Secondary | Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD) The morphology of the Neovascularization (CNV) complex was evaluated qualitatively by assessing the presence/absence of branching vessels. The presence of tiny vessels branching from bigger vessels is indicative of an active CNV lesion. UNG/P = Ungradable due to pathology UNG/Q = Ungradable due to Quality | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Total CNV Lesion Area (mm*2) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The total Basal Choroidal Neovascularization (CNV) lesion area (mm^2) and greatest linear diameter of lesion (mm) are the parameters related to CNV flow size. | Full Analysis Set - includes all patients with a CNV lesion who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Mean | Standard Deviation | mm^2 | Baseline, Week 16, Week 48 |
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| Secondary | Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Choroidal Neovascularization (CNV) Vascular Density (%) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The Choroidal Neovascularization (CNV) vascular density (%) is calculated as a ratio of the area occupied by vessels and the total area of the lesion and multiplied by 100. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Mean | Standard Deviation | % CNV Vascular Density | Baseline, Week 16, Week 48 |
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| Secondary | Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Lesion Greatest Linear Diameter (mm) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The total Basal Choroidal Neovascularization (CNV) lesion area (mm^2) and greatest linear diameter of lesion (mm) are the parameters related to CNV flow size. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Mean | Standard Deviation | mm | Baseline, Week 16, Week 48 |
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| Secondary | Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the peripheral anastomotic arcades. The presence of peripheral anastomotic arcades at the vessel termini is indicative of an active CNV lesion. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the vascular loops. The presence of vascular loops is indicative of an active CNV lesion. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the dark halo. The presence of dark halo is considered a region of choriocapillaris alteration corresponding to local flow impairment and is indicative of an active CNV lesion. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD) | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). The central retina thickness (CRT) evaluated in this study represents the average retinal thickness of the circular area within 1 mm diameter around the foveal center and was called Center Subfield Thickness (CST), also known as foveal thickness. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Mean | Standard Deviation | micrometers | Baseline, Week 16, Week 48 |
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| Secondary | Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD) | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Mean | Standard Deviation | micrometers | Baseline, Week 16, Week 48 |
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| Secondary | Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). IRF is the fluid that accumulates within the neurosensory retina due to the disruption of the external limiting membrane (ELM)-photoreceptor complex in the outer retina by the active Choroidal Neovascularization (CNV) membrane. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). SRF is the fluid that commonly accumulates between the neurosensory retina and the retinal pigment epithelium (RPE) due to the profuse leakage from blood vessels of the Choroidal Neovascularization (CNV) complex. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). Sub-RPE fluid, i.e., the fluid that accumulates under the RPE, thus often leading to Pigment Epithelial Detachments (PEDs). | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). SHRM, i.e., a poorly defined, medium-to-hyperreflective mass between the neurosensory layers and the sub retinal pigment epithelium (RPE) on SD-OCT, which is indicative of the neurovascular membrane, particularly in type II Choroidal Neovascularization (CNV) lesions, and of disciform scar formation | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). ORT, i.e., branching tubular structures located in the outer nuclear layer of the retina, which seems to be indicative of a rearrangement of degenerating photoreceptors in a variety of retinal diseases, including wAMD. On SD-OCT, ORT appears as well-defined round or ovoid hyporeflective spaces with hyperreflective borders. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss | Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). Status of the ELM as an indicator of retinal integrity was evaluated focusing on ELM integrity loss in center 1 mm (i.e., considering the central 1 x 1-mm subfield). | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Week 16, Week 48 |
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| Secondary | Change in Best-corrected Visual Acuity (BCVA) From Baseline up to Week 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. Participants with a BCVA ETDRS letter score of >= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Median | Inter-Quartile Range | Letters read | Baseline, Week 16, Week 48 |
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| Secondary | Number of Patients With Fluid Resolution of the Study Eye | Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Among patients with fluid present at Baseline, patients with fluid resolution were identified in case of absence of IRF and SRF and patients without fluid resolution were categorized in 'only IRF present', 'only SRF present', 'both IRF and SRF present' at each post-baseline timepoint. IRF = Intraretinal Fluid SRF = Subretinal Fluid | Full Analysis Set - includes all patients with fluid present at Baseline who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Week 16, Week 48 |
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| Secondary | Sustained Dryness of the Study Eye - Kaplan-Meier Estimates - Median Time to the Achievement of Sustained Dryness | Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Patients who achieved sustained dryness were identified considering those with fluid resolution for at least 2/3 consecutive visits. Median time to the achievement of sustained dryness was calculated by the Kaplan-Meier method. Sustained dryness of the study eye, is defined by the absence of IRF and SRF for at least 2 consecutive visits and for at least 3 consecutive visits. IRF = Intraretinal Fluid SRF = Subretinal Fluid | Full Analysis Set - includes all patients with fluid present at baseline and who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Median | 95% Confidence Interval | weeks | Up to Week 48 |
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| Secondary | Cumulative Incidence of Patients With Sustained Dryness of the Study Eye | Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Sustained dryness of the study eye, is defined by the absence of IRF and SRF for at least 2 consecutive visits and for at least 3 consecutive visits. IRF = Intraretinal Fluid SRF = Subretinal Fluid | Full Analysis Set - includes all patients with fluid present at baseline who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
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| Secondary | Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 | Evaluate the reasons underlying the Investigators' choice of brolucizumab treatment regimen (q8w) BVCA=Best-Corrected Visual Acuity, CFP=Color Fundus Photography; CNV=Choroidal Neovascularization; FA=Fluorescein Angiography; ICGA=IndoCyanine Green Angiography; OCTA=Optical Coherence Tomography Angiography; SD-OCT=Spectral Domain Optical Coherence Tomography | Full Analysis Set - iincludes Patients who performed Week 16 and still on treatment of brolucizumab dosing regimen (q8w) with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Up to Week 16 |
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| Secondary | Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 | Evaluate the reasons underlying the Investigators' choice of brolucizumab treatment regimen (q12w) BVCA=Best-Corrected Visual Acuity, CFP=Color Fundus Photography; CNV=Choroidal Neovascularization; FA=Fluorescein Angiography; ICGA=IndoCyanine Green Angiography; OCTA=Optical Coherence Tomography Angiography; SD-OCT=Spectral Domain Optical Coherence Tomography | Full Analysis Set - includes Patients who performed Week 16 and still on treatment of brolucizumab dosing regimen (q12w) with a valid measurement without a protocol deviation with impact. | Posted | Count of Participants | Participants | Up to Week 16 |
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| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Scores | Evaluate anxiety/depression in patients with wAMD treated with brolucizumab. The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale that generates ordinal data. Seven items relate to anxiety and seven relate to depression. This patient-reported outcome measure was specifically developed to avoid reliance on anxiety/depression aspects which are also common somatic symptoms of illness, such as fatigue and insomnia or hypersomnia. Calculations of scores: each item is rated on a 4-point scale. The HADS consists of two sub-scores: the HAD-A for anxiety and HAD-D for depression. Each sub-score ranges from 0 to 21 points: scores ≥11 indicate the presence of an anxious or depressive disorder, scores between 8-10 points are borderline abnormal, and scores ≤7 indicate that an anxious or depressive disorder is not present. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Mean | Standard Deviation | Scores on a scale | Up to Week 48 |
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| Secondary | Change in European Quality of Life-5D-5L (EQ-5D-5L) Scores | Evaluate quality of life in patients with wAMD treated with brolucizumab. The EQ-5D-5L is a standardized widely used instrument for measuring generic health status. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. i.e. no problems, slight problems, moderate problems, severe problems and extreme problems, corresponding to digit numbers ranging from 1 to 5. The EQ-5D-5L total score is determined through a Visual Analogue Scale (VAS) and ranges from 0 to 100 with higher scores indicative of a better health status. | Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 48 |
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| Secondary | Treatment Emergent Adverse Events | 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 | Safety Set - includes all patients who received at least one dose of the study drug | Posted | Count of Participants | Participants | AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks. |
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| Secondary | Ocular Treatment Emergent Adverse Events - 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 subject or clinical investigation subject | Safety Set - includes all patients who received at least one dose of the study drug | Posted | Count of Participants | Participants | AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks. |
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| Secondary | Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) | 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 | Safety Set - includes all patients who received at least one dose of the study drug | Posted | Count of Participants | Participants | AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks. |
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Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Not provided
Not provided
| 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 | Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA). | 0 | 122 | 14 | 122 | 52 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal occlusive vasculitis- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Uveitis- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Acute undifferentiated leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebellar ischaemia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Defect conduction intraventricular | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cataract- Both | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cataract- Fellow eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cataract- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Eye haemorrhage- Fellow eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Eye inflammation- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Iridocyclitis- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Macular degeneration- Fellow eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Macular detachment- Fellow eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Macular fibrosis- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Macular hole- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Maculopathy- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration- Fellow eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ocular hypertension- Both | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ocular hypertension- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal haemorrhage- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal pigment epithelial tear- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal tear- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal vascular disorder- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal vasculitis- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vision blurred- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Visual impairment- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vitreous floaters- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vitritis- Study eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctivitis bacterial- Both | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctivitis- Study eye | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Blood pressure abnormal | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Arachnoid cyst | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gliosis | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nystagmus- Fellow eye | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Epistaxis- Fellow eye | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vasculitis- Study eye | Vascular disorders | MedDRA (25.0) | 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 | Nov 28, 2023 | Sep 18, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| D057092 | Geographic Atrophy |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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