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Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.

One Year, Single Arm, Open Label, Multicenter, Phase IV Study Using Multimodal Imaging to Guide Disease Activity Assessment Through Innovative Early Predictive Anatomical Biomarkers of Fluid Resolution in wAMD Patients Treated With Brolucizumab- IMAGINE Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04774926
Acronym
IMAGINE
Enrollment
122
Registered
2021-03-01
Start date
2021-10-15
Completion date
2023-10-04
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Neovascular age-related macular degeneration, anti-VEGF, brolucizumab, choroidal neovascularization, multimodal imaging biomarkers, fluid resolution, Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD

Brief summary

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).

Detailed description

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.

Interventions

DRUGBrolucizumab

120 mg/ml solution for intravitreal injection

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The study is a one-year, open-label, single arm, multicenter, phase IV study in patients with wAMD.

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Signed written informed consent must be obtained prior to participation in the study * Active choroidal neo-vascularization (CNV) secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography (or other imaging modalities) and sequelae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema in the study eye at Screening; * Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield (study eye), as seen by SD-OCT in the study eye at Screening; * Best-corrected visual acuity (BCVA) score greater than or equal to 23 letters measured at 4-meters starting distance using Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity charts at both Screening and Baseline visits in the study eye.

Exclusion criteria

* Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in study eye at Screening or Baseline; * Not interpretable OCTA and SD-OCT images according to Investigator's clinical judgment at Screening in the study eye; * Concomitant conditions or ocular disorders in the study eye, at Screening or Baseline which, in the opinion of the Investigator, could prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the course of the study; * Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 mmHg on medication or according to Investigator's judgment at Screening or Baseline; * Previous treatment with any anti-vascular endothelial growth factor (anti-Vascular endothelial growth factor (VEGF)) drugs or investigational drugs (other than vitamin supplements) in the study eye at any time prior to Screening; * Systemic anti-VEGF therapy at any time; * Stroke or myocardial infarction in the 6-month period prior to Baseline.

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients Classified as q12w Fluid-free or Not q12w Fluid-freeUp to Week 48Early 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: * Pt who completed treatment and the study with the presence of IRF or SRF at Wk 48 * Pt who followed the q8w regimen of treatment at any time during the study (considering also who started with q12w regimen but then due to disease activity shifted to q8w regimen) * Pt who discontinued treatment at any time after b/l since treatment disc. was considered as intercurrent event and a 'failure'. * Pt who dropped out at any time after b/l since study disc. was considered as intercurrent event and a 'failure'.
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-freeBaselineAs 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
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-freeBaselineAs 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
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-freeBaseline to Week 16As 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').
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-freeBaseline to Week 16As 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').
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-freeBaseline to Week 16As 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').
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-freeBaseline to Week 16As 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').
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-freeBaseline to Week 16As 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').
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-freeBaseline to Week 16As 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').
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-freeBaseline to Week 16As 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').
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-freeBaseline to Week 16As 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').
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-freeBaseline to Week 16As 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. * Stable Fibrovascular only (i.e., all measurements 'Fibrovascular only'). * Stable not only fibrovascular (i.e., all measurements 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid Pigment Epithelial Detachment (PED)'). * From not only fibrovascular to Fibrovascular only (i.e., last measurement collected 'Fibrovascular only' and baseline 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED'). * From Fibrovascular only to not only fibrovascular (i.e., last measurement collected 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED' and baseline 'Fibrovascular only').
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-freeBaseline to Week 16As 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. * Stable Fibrovascular only (i.e., all measurements 'Fibrovascular only'). * Stable not only fibrovascular (i.e., all measurements 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid Pigment Epithelial Detachment (PED)'). * From not only fibrovascular to Fibrovascular only (i.e., last measurement collected 'Fibrovascular only' and baseline 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED'). * From Fibrovascular only to not only fibrovascular (i.e., last measurement collected 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED' and baseline 'Fibrovascular only').
Potential Predictor Factors of Fluid-free Response: Percentage Changes in Central Subfield Thickness (CST) From Baseline at Week 16 - Patients Classified as q12w Fluid-freeBaseline, Week 16As 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.
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-freeBaseline, Week 16As 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.

Secondary

MeasureTime frameDescription
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossBaseline, Week 16, Week 48Evaluate 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).
Change in Best-corrected Visual Acuity (BCVA) From Baseline up to Week 48Baseline, Week 16, Week 48BCVA 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.
Number of Patients With Fluid Resolution of the Study EyeWeek 16, Week 48Evaluate 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
Sustained Dryness of the Study Eye - Kaplan-Meier Estimates - Median Time to the Achievement of Sustained DrynessUp to Week 48Evaluate 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
Cumulative Incidence of Patients With Sustained Dryness of the Study EyeWeeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48Evaluate 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
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Up to Week 16Evaluate 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
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Up to Week 16Evaluate 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
Change in Hospital Anxiety and Depression Scale (HADS) ScoresUp to Week 48Evaluate 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.
Change in European Quality of Life-5D-5L (EQ-5D-5L) ScoresBaseline, Week 48Evaluate 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.
Treatment Emergent Adverse EventsAEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
Ocular Treatment Emergent Adverse Events - Study EyeAEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBaseline, Week 16, Week 48Evaluate 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
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Total CNV Lesion Area (mm*2)Baseline, Week 16, Week 48Evaluate 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.
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Choroidal Neovascularization (CNV) Vascular Density (%)Baseline, Week 16, Week 48Evaluate 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.
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Lesion Greatest Linear Diameter (mm)Baseline, Week 16, Week 48Evaluate 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.
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesBaseline, Week 16, Week 48Evaluate 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.
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsBaseline, Week 16, Week 48Evaluate 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.
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloBaseline, Week 16, Week 48Evaluate 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.
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED)Baseline, Week 16, Week 48Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD)
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm)Baseline, Week 16, Week 48Evaluate 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.
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48Baseline, Week 16, Week 48Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD)
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaBaseline, Week 16, Week 48Evaluate 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.
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)Baseline, Week 16, Week 48Evaluate 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.
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidBaseline, Week 16, Week 48Evaluate 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).
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)Baseline, Week 16, Week 48Evaluate 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
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)Baseline, Week 16, Week 48Evaluate 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.

Countries

Italy

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
Brolucizumab 6 mg
Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
122
Total122

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event15
Overall StudyLost to Follow-up3
Overall StudyPhysician Decision6
Overall StudyThe original PI resigned and a new one could not be appointed4
Overall StudyWithdrawal by Subject3

Baseline characteristics

CharacteristicBrolucizumab 6 mg
Age, Continuous76.1 Years
STANDARD_DEVIATION 7.88
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
122 Participants
Sex: Female, Male
Female
72 Participants
Sex: Female, Male
Male
50 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 122
other
Total, other adverse events
52 / 122
serious
Total, serious adverse events
14 / 122

Outcome results

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: * Pt who completed treatment and the study with the presence of IRF or SRF at Wk 48 * Pt who followed the q8w regimen of treatment at any time during the study (considering also who started with q12w regimen but then due to disease activity shifted to q8w regimen) * Pt who discontinued treatment at any time after b/l since treatment disc. was considered as intercurrent event and a 'failure'. * Pt who dropped out at any time after b/l since study disc. was considered as intercurrent event and a 'failure'.

Time frame: Up to Week 48

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgNumber of Patients Classified as q12w Fluid-free or Not q12w Fluid-freeq12w fluid free - NO93 Participants
Brolucizumab 6 mgNumber of Patients Classified as q12w Fluid-free or Not q12w Fluid-freeq12w fluid free - YES27 Participants
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').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-freeStable absent; q12w fluid free - No25 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-freeStable present; q12w fluid free- No43 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-freeImproved; q12w fluid free - No11 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-freeWorsened; q12w fluid free - No14 Participants
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').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-freeStable absent; q12w fluid free - Yes8 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-freeStable present; q12w fluid free - Yes13 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-freeImproved; q12w fluid free - Yes3 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-freeWorsened; q12w fluid free - Yes3 Participants
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').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-freeStable absent; q12w fluid free - No84 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-freeStable present; q12w fluid free - No1 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-freeImproved; q12w fluid free - No3 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-freeWorsened; q12w fluid free - No5 Participants
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').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-freeStable absent; q12w fluid free - Yes25 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-freeStable present; q12w fluid free - Yes2 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-freeImproved; q12w fluid free - Yes0 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-freeWorsened; q12w fluid free - Yes0 Participants
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.

Time frame: Baseline, Week 16

Population: 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.)

ArmMeasureValue (MEAN)Dispersion
Brolucizumab 6 mgPotential 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-31.7 Percentage changeStandard Deviation 18.28
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.

Time frame: Baseline, Week 16

Population: 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.)

ArmMeasureValue (MEAN)Dispersion
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Percentage Changes in Central Subfield Thickness (CST) From Baseline at Week 16 - Patients Classified as q12w Fluid-free-36.4 Percentage changeStandard Deviation 16.85
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').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-freeStable absent; q12w fluid free - No41 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-freeStable present; q12w fluid free - No33 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-freeImproved; q12w fluid free - No7 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-freeWorsened; q12w fluid free - No12 Participants
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').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-freeStable absent; q12w fluid free - Yes11 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-freeStable present; q12w fluid free - Yes7 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-freeImproved; q12w fluid free - Yes4 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-freeWorsened; q12w fluid free - Yes5 Participants
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').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-freeStable absent; q12w fluid free - No39 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-freeStable present; q12w fluid free - No32 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-freeImproved; q12w fluid free - No20 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-freeWorsened; q12w fluid free - No2 Participants
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').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-freeStable absent; q12w fluid free - Yes12 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-freeStable present; q12w fluid free - Yes7 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-freeImproved; q12w fluid free - Yes8 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-freeWorsened; q12w fluid free - Yes0 Participants
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. * Stable Fibrovascular only (i.e., all measurements 'Fibrovascular only'). * Stable not only fibrovascular (i.e., all measurements 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid Pigment Epithelial Detachment (PED)'). * From not only fibrovascular to Fibrovascular only (i.e., last measurement collected 'Fibrovascular only' and baseline 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED'). * From Fibrovascular only to not only fibrovascular (i.e., last measurement collected 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED' and baseline 'Fibrovascular only').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-freeStable Fibrovascular only; q12w fluid free - No38 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-freeStable not only fibrovascular; q12w fluid free - No28 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-freeFrom not only fibrovascular to Fibrovascular only; q12w fluid free - No24 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-freeFrom Fibrovascular only to not only fibrovascular; q12w fluid free - No3 Participants
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. * Stable Fibrovascular only (i.e., all measurements 'Fibrovascular only'). * Stable not only fibrovascular (i.e., all measurements 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid Pigment Epithelial Detachment (PED)'). * From not only fibrovascular to Fibrovascular only (i.e., last measurement collected 'Fibrovascular only' and baseline 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED'). * From Fibrovascular only to not only fibrovascular (i.e., last measurement collected 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED' and baseline 'Fibrovascular only').

Time frame: Baseline to Week 16

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-freeStable Fibrovascular only; q12w fluid free - Yes13 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-freeStable not only fibrovascular; q12w fluid free - Yes7 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-freeFrom not only fibrovascular to Fibrovascular only; q12w fluid free - Yes7 Participants
Brolucizumab 6 mgPotential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-freeFrom Fibrovascular only to not only fibrovascular; q12w fluid free - Yes0 Participants
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

Time frame: Baseline

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential 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-freeTYPE I + PCV; q12w fluid free - No61 Participants
Brolucizumab 6 mgPotential 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-freeTYPE II; q12w fluid free - No21 Participants
Brolucizumab 6 mgPotential 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-freeTYPE III; q12w fluid free - No5 Participants
Brolucizumab 6 mgPotential 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-freeMissing; q12w fluid free - No6 Participants
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

Time frame: Baseline

Population: 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.)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgPotential 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-freeTYPE I + PCV; q12w fluid free - Yes19 Participants
Brolucizumab 6 mgPotential 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-freeTYPE II; q12w fluid free - Yes4 Participants
Brolucizumab 6 mgPotential 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-freeTYPE III; q12w fluid free - Yes3 Participants
Brolucizumab 6 mgPotential 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-freeMissing; q12w fluid free- Yes1 Participants
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (MEDIAN)
Brolucizumab 6 mgChange in Best-corrected Visual Acuity (BCVA) From Baseline up to Week 48Week 164.0 Letters read
Brolucizumab 6 mgChange in Best-corrected Visual Acuity (BCVA) From Baseline up to Week 48Week 485.5 Letters read
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.

Time frame: Baseline, Week 48

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Brolucizumab 6 mgChange in European Quality of Life-5D-5L (EQ-5D-5L) Scores0.00 Scores on a scaleStandard Deviation 0.147
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.

Time frame: Up to Week 48

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Brolucizumab 6 mgChange in Hospital Anxiety and Depression Scale (HADS) ScoresHAD-A - Absolute change from baseline at Week 48-0.78 Scores on a scaleStandard Deviation 3.258
Brolucizumab 6 mgChange in Hospital Anxiety and Depression Scale (HADS) ScoresHAD-D - Absolute change from baseline at Week 48-0.10 Scores on a scaleStandard Deviation 3.049
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

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - Increased from prior - Week 1611 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - Increased from prior - Week 48 (n=91)4 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - Decreased from prior - Week 162 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - Decreased from prior - Week 48 (n=91)11 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - Stable - Week 1626 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - Stable - Week 48 (n=91)20 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - UNG/P - Week 169 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - UNG/P - Week 48 (n=91)21 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - UNG/Q - Week 1666 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching VesselsBranching Vessels - UNG/Q - Week 48 (n=91)35 Participants
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Choroidal Neovascularization (CNV) Vascular Density (%)Week 161.326 % CNV Vascular DensityStandard Deviation 35.6003
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Choroidal Neovascularization (CNV) Vascular Density (%)Week 48 (n=8)29.900 % CNV Vascular DensityStandard Deviation 52.3079
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Lesion Greatest Linear Diameter (mm)Week 16-0.211 mmStandard Deviation 0.5416
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Lesion Greatest Linear Diameter (mm)Week 48 (n=20)-0.147 mmStandard Deviation 0.5837
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Total CNV Lesion Area (mm*2)Week 16 (n=27)0.476 mm^2Standard Deviation 1.0012
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Total CNV Lesion Area (mm*2)Week 48 (n=20)0.533 mm^2Standard Deviation 0.9053
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloNo at Baseline and No at Week 16 (n=15)9 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloYes at Baseline and No at Week 16 (n=15)2 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloNo at Baseline and Yes at Week 16 (n=15)0 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloYes at Baseline and Yes at Week 16 (n=15)4 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloNo at Baseline and No at Week 48 (n=17)6 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloYes at Baseline and No at Week 48 (n=17)5 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloNo at Baseline and Yes at Week 48 (n=17)2 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark HaloYes at Baseline and Yes at Week 48 (n=17)4 Participants
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesNo at Baseline and No at Week 1614 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesYes at Baseline and No at Week 161 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesNo at Baseline and Yes at Week 164 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesYes at Baseline and Yes at Week 166 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesNo at Baseline and No at Week 48 (n=21)7 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesYes at Baseline and No at Week 48 (n=21)2 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesNo at Baseline and Yes at Week 48 (n=21)8 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic ArcadesYes at Baseline and Yes at Week 48 (n=21)4 Participants
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsNo at Baseline and No at Week 1612 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsYes at Baseline and No at Week 161 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsNo at Baseline and Yes at Week 163 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsYes at Baseline and Yes at Week 1610 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsNo at Baseline and No at Week 48 (n=22)4 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsYes at Baseline and No at Week 48 (n=22)3 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsNo at Baseline and Yes at Week 48 (n=22)7 Participants
Brolucizumab 6 mgChange in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular LoopsYes at Baseline and Yes at Week 48 (n=22)8 Participants
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)

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48Week 16-188.4 micrometersStandard Deviation 142.79
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48Week 48 (n=60)-197.6 micrometersStandard Deviation 152.63
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).

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossNo at Baseline and No at Week 1630 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossYes at Baseline and No at Week 1614 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossNo at Baseline and Yes at Week 1615 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossYes at Baseline and Yes at Week 1654 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossNo at Baseline and No at Week 48 (n=91)24 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossYes at Baseline and No at Week 48 (n=91)9 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossNo at Baseline and Yes at Week 48 (n=91)15 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity LossYes at Baseline and Yes at Week 48 (n=91)43 Participants
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaNo at Baseline and No at Week 1646 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaYes at Baseline and No at Week 1638 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaNo at Baseline and Yes at Week 164 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaYes at Baseline and Yes at Week 1626 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaNo at Baseline and No at Week 48 (n=92)40 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaYes at Baseline and No at Week 48 (n=92)30 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaNo at Baseline and Yes at Week 48 (n=92)1 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid EdemaYes at Baseline and Yes at Week 48 (n=92)21 Participants
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)No at Baseline and No at Week 16103 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)Yes at Baseline and No at Week 163 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)No at Baseline and Yes at Week 165 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)Yes at Baseline and Yes at Week 163 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)No at Baseline and No at Week 48 (n=92)77 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)Yes at Baseline and No at Week 48 (n=92)3 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)No at Baseline and Yes at Week 48 (n=92)10 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT)Yes at Baseline and Yes at Week 48 (n=92)2 Participants
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)No at Baseline and No at Week 167 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)Yes at Baseline and No at Week 1675 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)No at Baseline and Yes at Week 161 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)Yes at Baseline and Yes at Week 1631 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)No at Baseline and No at Week 48 (n=92)6 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)Yes at Baseline and No at Week 48 (n=92)57 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)No at Baseline and Yes at Week 48 (n=92)0 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF)Yes at Baseline and Yes at Week 48 (n=92)29 Participants
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

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)No at Baseline and No at Week 1650 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)Yes at Baseline and No at Week 1611 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)No at Baseline and Yes at Week 1616 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)Yes at Baseline and Yes at Week 1637 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)No at Baseline and No at Week 48 (n=92)45 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)Yes at Baseline and No at Week 48 (n=92)14 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)No at Baseline and Yes at Week 48 (n=92)8 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM)Yes at Baseline and Yes at Week 48 (n=92)25 Participants
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).

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidNo at Baseline and No at Week 1649 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidYes at Baseline and No at Week 1626 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidNo at Baseline and Yes at Week 161 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidYes at Baseline and Yes at Week 1638 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidNo at Baseline and No at Week 48 (n=92)36 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidYes at Baseline and No at Week 48 (n=92)26 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidNo at Baseline and Yes at Week 48 (n=92)2 Participants
Brolucizumab 6 mgChange in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) FluidYes at Baseline and Yes at Week 48 (n=92)28 Participants
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

Time frame: Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 836 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 1254 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 1664 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 2068 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 2468 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 2868 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 3273 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 3676 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 4077 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 4477 Participants
Brolucizumab 6 mgCumulative Incidence of Patients With Sustained Dryness of the Study EyePatients with sustained dryness - Week 4878 Participants
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

Time frame: Up to Week 16

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Hemorrhage at CFP17 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Vessel morphology at OCTA13 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Vessel density at OCTA11 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Other - investigator's discretion11 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Leakage at FA/ICGA0 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Intraretinal fluid (IRF) at SD-OCT46 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Subretinal fluid (SRF) at SD-OCT41 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Central Subfield Thickness (CST) at SD-OCT35 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16BCVA29 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Subretinal pigment epithelium (sub-RPE) fluid at SD-OCT26 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Central Retinal Thickness (CRT)26 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Subretinal hyperreflective material (SHRM) at SD-OCT22 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16Retina Pigment Epithelial Detachment volume at SD-OCT19 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16CNV size at OCTA18 Participants
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

Time frame: Up to Week 16

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Intraretinal fluid (IRF) at SD-OCT17 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Subretinal fluid (SRF) at SD-OCT21 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Central Subfield Thickness (CST) at SD-OCT15 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Best-corrected visual acuity (BCVA)13 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Subretinal pigment epithelium (sub-RPE) fluid at SD-OCT4 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Central Retinal Thickness (CRT)4 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Subretinal hyperreflective material (SHRM) at Domain Optical Coherence Tomography. (SD-OCT)6 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Retina Pigment Epithelial Detachment volume at SD-OCT3 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16CNV size at OCTA2 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Hemorrhage at CFP2 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Vessel morphology at OCTA2 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Vessel density at OCTA3 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Other - investigator's discretion2 Participants
Brolucizumab 6 mgDeterminants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16Leakage at FA/ICGA0 Participants
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

Time frame: Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients with fluid resolution - Week 1664 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients without fluid resolution - Week 1649 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients without fluid resolution - Only IRF present - Week 16 (n=49)18 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients without fluid resolution - Only SRF present - Week 16 (n=49)19 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients without fluid resolution - Both IRF and SRF present - Week 16 (n=49)12 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients with fluid resolution - Week 48 (n=92)49 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyeUnknown- Week 48 (n=92)1 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients without fluid resolution - Week 48 (n=92)42 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients without fluid resolution - Only IRF present - Week 48 (n=42)13 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients without fluid resolution - Only SRF present - Week 48 (n=42)20 Participants
Brolucizumab 6 mgNumber of Patients With Fluid Resolution of the Study EyePatients without fluid resolution - Both IRF and SRF present - Week 48 (n=42)9 Participants
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

Time frame: AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.

Population: Safety Set - includes all patients who received at least one dose of the study drug

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Retinal vasculitis1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)Eye disorders30 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Cataract3 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Conjunctival haemorrhage1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Eye haemorrhage1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Eye inflammation2 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Iridocyclitis1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Macular degeneration1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Macular detachment1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Macular fibrosis2 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Macular hole3 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Maculopathy1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Neovascular age-related macular degeneration3 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Ocular hypertension2 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Retinal haemorrhage1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Retinal occlusive vasculitis1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Retinal pigment epithelial tear3 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Retinal tear2 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Retinal vascular disorder1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Uveitis1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Vision blurred1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Visual impairment1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Vitreous floaters1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT)-Vitritis5 Participants
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

Time frame: AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.

Population: Safety Set - includes all patients who received at least one dose of the study drug

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - Study EyePatients with Ocular TEAEs25 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - Study EyePatients with Serious Ocular TEAEs1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - Study EyePatients with suspected drug-related Ocular TEAEs11 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - Study EyePatients with Ocular TEAEs related to Ocular injection procedure3 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - Study EyePatients with Ocular TEAEs leading to temporary interruption of treatment1 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - Study EyePatients with Ocular TEAEs leading to withdrawn of treatment10 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - Study EyePatients with Ocular TEAEs leading to study discontinuation5 Participants
Brolucizumab 6 mgOcular Treatment Emergent Adverse Events - Study EyePatients with Ocular TEAEs with fatal outcome0 Participants
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.

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Brolucizumab 6 mgSpectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm)Baseline482.6 micrometersStandard Deviation 177.4
Brolucizumab 6 mgSpectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm)Week 16 (n=114)309.2 micrometersStandard Deviation 107.69
Brolucizumab 6 mgSpectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm)Week 48 (n=93)307.9 micrometersStandard Deviation 118.05
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)

Time frame: Baseline, Week 16, Week 48

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgSpectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED)Yes - Baseline120 Participants
Brolucizumab 6 mgSpectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED)Yes - Week 16 (n=114)114 Participants
Brolucizumab 6 mgSpectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED)Yes - Week 48 (n=93)92 Participants
Brolucizumab 6 mgSpectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED)Missing - Week 48 (n=93)1 Participants
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

Time frame: Up to Week 48

Population: 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.

ArmMeasureValue (MEDIAN)
Brolucizumab 6 mgSustained Dryness of the Study Eye - Kaplan-Meier Estimates - Median Time to the Achievement of Sustained Dryness16.43 weeks
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

Time frame: AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.

Population: Safety Set - includes all patients who received at least one dose of the study drug

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with suspected drug-related TEAEs13 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with TEAEs related to Ocular injection procedure4 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with TEAEs59 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with Serious TEAEs14 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with Ocular TEAEs33 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with non-ocular TEAEs40 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with TEAEs leading to temporary interruption of treatment2 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with TEAEs leading to withdrawn of treatment15 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with TEAEs leading to study discontinuation7 Participants
Brolucizumab 6 mgTreatment Emergent Adverse EventsPatients with TEAEs with fatal outcome0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026