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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004145-33 | EudraCT Number |
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Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss.
This is a prospective, single-arm, open-label, multicenter study to evaluate the efficacy and safety of brolucizumab 6 mg in pretreated suboptimal anatomically controlled patients with neovascular age-related macular degeneration (nAMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTH258/Brolucizumab | Experimental | This is a single arm study in which all patients will be treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTH258/Brolucizumab | Drug | Brolucizumab is a new generation of anti-VEGF (vascular endothelial growth factor). All patients will be treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by Treat-to-Control regimen up to Week 44/46. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With no Disease Activity at Week 16 in the Study Eye | Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:
| Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With no Disease Activity at Week 48 in the Study Eye | Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:
|
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Inclusion Criteria:
Patients must provide written informed consent before any study-related procedures are performed.
Patients must be 50 years of age or older at Screening/Baseline.
Study eye:
Active CNV lesions secondary to nAMD diagnosed < 18 months prior to Screening/Baseline that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by FA and sequelae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub RPE hemorrhage, blocked fluorescence, or macular edema.
Previous treatment with only one licensed anti-VEGF drug (i.e. Lucentis®, Eylea®) with a ≥ Q4 and ≤ Q8 treatment (treatment interval of 26 to 62 days inclusive) with licensed anti-VEGF (a minimal washout period of at least 4 weeks / 26 days is required). Patients must have received at least 3 injections of this anti-VEGF in the 6 months prior to Screening/Baseline.
Presence of residual fluid (IRF or SRF that affects the central subfield under, as seen by OCT)
BCVA score must be ≤ 83 and ≥ 38 letters at an initial testing distance of 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at Screening/Baseline.
Exclusion Criteria:
Ocular conditions
Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis), in either eye at Screening/Baseline.
Presence of amblyopia, amaurosis, or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Screening/Baseline (except when due to conditions whose surgery may improve visual acuity, e.g. cataract).
Medical history of intraocular inflammation and/or retinal vascular occlusion within 12 months prior to Screening/Baseline
Study eye
Poor quality of OCT image at Screening/Baseline.
Atrophy or fibrosis involving the center of the fovea in the study eye, as assessed by CFP and fundus autofluorescence (FAF).
The total area of fibrosis or subretinal blood affecting the foveal center point comprising ≥ 50% of the lesion area in the study eye.
Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product.
Structural damage within 0.5 disc diameter of the center of the macula in the study eye, e.g. vitreomacular traction, epiretinal membrane, RPE rip/tear scar, laser burn, at the time of Screening/Baseline that in the Investigator's opinion could preclude visual function improvement with treatment.
Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Screening/Baseline.
Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to the Investigator's judgment, at Screening/Baseline.
Aphakia and/or absence of the posterior capsule in the study eye. Ocular treatments (study eye)
Patient has received any investigational treatment for nAMD (other than vitamin supplements) in the study eye at any time.
Previous use of intraocular or periocular of corticosteroids in the study eye within the 6 month period prior to Screening/Baseline.
Previous penetrating keratoplasty or vitrectomy at any time prior to Screening/Baseline.
History or evidence of the following in the study eye within the 90-day period prior to Screening/Baseline:
Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline.
Previous treatment with investigational drugs.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nice | Cedex1 | 06001 | France | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37343623 | Derived | Bodaghi B, Souied EH, Tadayoni R, Weber M, Ponthieux A, Kodjikian L. Detection and Management of Intraocular Inflammation after Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Oct;7(10):879-891. doi: 10.1016/j.oret.2023.06.009. Epub 2023 Jun 19. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Before inclusion, patients underwent a 4-to-8-Week Washout Period (from 26 to 62 days) from the last administration of a licensed anti-VEGF drug (i.e., Lucentis®, Eylea®).
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| ID | Title | Description |
|---|---|---|
| FG000 | RTH258/Brolucizumab | This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2022 | Aug 23, 2023 |
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Single-arm, open-label study
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|
| Week 48 |
| Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Baseline, Weeks 4,8,16, 48 |
| Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye | Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. At week 8, for 1 patient, the fluid assessment was performed, but result is unknown; at week 16, for 1 patient, the fluid assessment was performed, but result is unknown; at week 48, for 2 patients, the fluid assessment was performed, but result is unknown. | Baseline, Week 4, 8, 16, 48 |
| Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye | Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Baseline, Weeks 4, 8, 16, 48 |
| Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:
| Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks |
| Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:
| Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks |
| Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Baseline, Weeks 4, 8, 16, 48 |
| Summary of Treatment-emergent Adverse Events - Overall | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. |
| Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. |
| Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Non-ocular | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. |
| Rennes |
| FRA |
| 35033 |
| France |
| Novartis Investigative Site | Saint-Cyr-sur-Loire | Indre Et Loire | 37540 | France |
| Novartis Investigative Site | Lyon | Rhone | 69317 | France |
| Novartis Investigative Site | Bobigny | Seine Saint Denis | 93009 | France |
| Novartis Investigative Site | Aix-en-Provence | 13090 | France |
| Novartis Investigative Site | Angers | 49044 | France |
| Novartis Investigative Site | Avignon | 84000 | France |
| Novartis Investigative Site | Bordeaux | 33000 | France |
| Novartis Investigative Site | Bordeaux | 33076 | France |
| Novartis Investigative Site | Caen | 14000 | France |
| Novartis Investigative Site | Caen | 14033 | France |
| Novartis Investigative Site | Colmar | 68024 | France |
| Novartis Investigative Site | Créteil | 94000 | France |
| Novartis Investigative Site | Dijon | 21034 | France |
| Novartis Investigative Site | Grenoble | 38000 | France |
| Novartis Investigative Site | La Rochelle | 17019 | France |
| Novartis Investigative Site | La Valette-du-Var | 83160 | France |
| Novartis Investigative Site | Le Chesnay | 78157 | France |
| Novartis Investigative Site | Lille | 59000 | France |
| Novartis Investigative Site | Lyon | 69002 | France |
| Novartis Investigative Site | Lyon | 69275 | France |
| Novartis Investigative Site | Marseille | 13015 | France |
| Novartis Investigative Site | Marseille | F 13008 | France |
| Novartis Investigative Site | Melun | 77000 | France |
| Novartis Investigative Site | Montargis | 45200 | France |
| Novartis Investigative Site | Montauban | 82000 | France |
| Novartis Investigative Site | Montpellier | 34000 | France |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Mulhouse | 68070 | France |
| Novartis Investigative Site | Nantes | 44093 | France |
| Novartis Investigative Site | Nantes | 44300 | France |
| Novartis Investigative Site | Paris | 75001 | France |
| Novartis Investigative Site | Paris | 75007 | France |
| Novartis Investigative Site | Paris | 75010 | France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Paris | 75651 | France |
| Novartis Investigative Site | Paris | 75674 | France |
| Novartis Investigative Site | Perpignan | 66000 | France |
| Novartis Investigative Site | Plérin | 22190 | France |
| Novartis Investigative Site | Poitiers | 86000 | France |
| Novartis Investigative Site | Rouen | 76100 | France |
| Novartis Investigative Site | Rueil-Malmaison | 92500 | France |
| Novartis Investigative Site | Saint-Herblain | 44819 | France |
| Novartis Investigative Site | Saint-Jean | 31240 | France |
| Novartis Investigative Site | Saint-Jean-de-Védas | 34430 | France |
| Novartis Investigative Site | Saint-Martin-des-Champs | 50300 | France |
| Novartis Investigative Site | Strasbourg | 67000 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Tours | 37000 | France |
| Novartis Investigative Site | Vincennes | 94300 | France |
| Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RTH258/Brolucizumab | This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With no Disease Activity at Week 16 in the Study Eye | Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:
| Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment of disease activity at Week 16. | Posted | Count of Participants | Participants | Week 16 |
|
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| Secondary | Number of Patients With no Disease Activity at Week 48 in the Study Eye | Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:
| Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment of disease activity at Week 48. | Posted | Count of Participants | Participants | Week 48 |
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and had at least one valid post-baseline assessment. | Posted | Mean | Standard Deviation | μm | Baseline, Weeks 4,8,16, 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye | Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. At week 8, for 1 patient, the fluid assessment was performed, but result is unknown; at week 16, for 1 patient, the fluid assessment was performed, but result is unknown; at week 48, for 2 patients, the fluid assessment was performed, but result is unknown. | Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact | Posted | Count of Participants | Participants | Baseline, Week 4, 8, 16, 48 |
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| Secondary | Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye | Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact. | Posted | Count of Participants | Participants | Baseline, Weeks 4, 8, 16, 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:
| Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact | Posted | Count of Participants | Participants | Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks |
| ||||||||||||||||||||||||||||
| Secondary | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed:
| Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact | Posted | Count of Participants | Participants | Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks |
| ||||||||||||||||||||||||||||
| Secondary | Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact with at least one valid post baseline assessment. | Posted | Mean | Standard Deviation | Letters read | Baseline, Weeks 4, 8, 16, 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Summary of Treatment-emergent Adverse Events - Overall | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment, which includes 6 patients who were randomized but not treated. | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. |
|
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| Secondary | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment. | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. |
|
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| Secondary | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Non-ocular | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. | Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment. | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. |
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| Post-Hoc | All Collected Deaths | On-treatment - up to 52 weeks; Post-treatment - greater than 30 days after last treatment, up to a maximum timeframe of 81 days after treatment | Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment. | Posted | Count of Participants | Participants | On-treatment - up to 52 weeks; Post-treatment - greater than 30 days after last treatment, up to 81 days post-treatment |
|
|
On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RTH258/Brolucizumab | This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen. | 2 | 295 | 28 | 295 | 148 | 295 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cyclitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye haematoma - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye inflammation - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Iridocyclitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal artery occlusion - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal occlusive vasculitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Uveitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitritis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Traumatic intracranial haematoma | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Age-related macular degeneration - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anterior chamber cell - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cataract - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cataract - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cataract - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Conjunctival haemorrhage - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diplopia - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry eye - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry eye - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyschromatopsia - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye inflammation - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye irritation - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye irritation - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye pain - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye pruritus - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eyelid irritation | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Glaucoma - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Iridocyclitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Keratitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lacrimation increased - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Macular hole - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ocular hyperaemia - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ocular hypertension - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ocular hypertension - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ocular hypertension - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ocular vasculitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Posterior capsule opacification - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Posterior capsule opacification - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Posterior capsule opacification - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal degeneration - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal detachment - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal drusen - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal haemorrhage - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal haemorrhage - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal occlusive vasculitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal perivascular sheathing - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal perivascular sheathing - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal pigment epithelial tear - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal tear - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal vasculitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Serous retinal detachment - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Uveitis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vision blurred - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vision blurred - Fellow eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vision blurred - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Visual acuity reduced - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Visual field defect - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitreous detachment - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitreous floaters - Both eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitreous floaters - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitreous haemorrhage - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitreous opacities - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitritis - Study eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gingival erosion | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Allergy to synthetic fabric | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asymptomatic COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Conjunctivitis - Both eye | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Conjunctivitis - Study eye | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Dermatophytosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Herpes ophthalmic - Study eye | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Foreign body in eye - Both eye | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Procedural pain - Study eye | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Thermal burn - Both eye | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Intraocular pressure increased - Both eye | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Intraocular pressure increased - Study eye | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Psychomotor skills impaired | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract polyp | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| White coat hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2023 | Mar 22, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| D057092 | Geographic Atrophy |
| D057135 | Wet Macular Degeneration |
| D012170 | Retinal Vein Occlusion |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
Not provided
Not provided
Not provided
| >=65 years |
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