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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002349-40 | EudraCT Number |
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The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective was to assess brolucizumab's potential for long durability up to 20 weeks.
All eligible participants were treated with brolucizumab regardless of their treatment in the TALON study.
The study period was 56 weeks including post-treatment follow-up.
This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study.
The maximum study duration for a subject was 56 weeks, including post-treatment follow-up.
There were two periods in this study:
All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).
Treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brolucizumab 6 mg | Experimental | Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brolucizumab | Drug | brolucizumab 6 mg/0.05 mL solution for intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye | Number of subjects in every 4 weeks (q4w), every 8 weeks (q8w), every 12 weeks (q12w) and every 20 weeks (q20w) intervals at last interval with no disease activity up to Week 56. Last interval with no disease activity (number of weeks): Number of subjects at 20/16/12/8/4-weeks intervals up to Week 56 for the study eye in the extension study | Up to Week 56 |
| Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye | Best-Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. The average change in BCVA from Baseline of the extension study at Week 52 and Week 56 was estimated by an analysis of variance (ANOVA) with baseline age categories, baseline BCVA categories and treatment arm in the core study included as fixed effects. Last observation carried forward (LOCF) was used to impute missing BCVA values. | Extension study baseline, average of Week 52 and Week 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye | Central Subfield Thickness (μm): Analysis of Variance (ANOVA) results for the average change from extension study Baseline at Week 52 and Week 56 for the study eye in the extension study by core study treatment arm. Central Subfield Thickness was assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Huntington Beach | California | 92647 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brolucizumab 6 mg (Extension Study Total) | Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity. |
| 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 | Oct 20, 2021 | Feb 27, 2024 |
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| Extension study baseline, average of Week 52 and Week 56 |
| Number (%) of Subjects With Presence of IRF and/or SRF, and Sub-RPE Fluid in the Study Eye at Week 52 and Week 56 Overall and by Core Study Treatment Arm | Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) status in the central subfield as assessed by Spectral Domain Ocular Coherence Tomography (SD-OCT): Number (%) of subjects with presence of IRF and/or SRF, and sub-Retinal Pigment Epithelium (RPE) fluid in the study eye at Week 52 and Week 56 overall and by core study treatment arm | Weeks 52 and 56 |
| Last Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study by Core Study Randomized Treatment Arm | Duration of the last interval with no disease activity up to Week 52 by core study treatment arm. | up to Week 56 |
| Maximal Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study | Duration of the maximal intervals with no disease activity up to Week 52 by core study treatment arm. | up to Week 56 |
| Number (%) of Subjects With Change in Duration of Last Interval With no Disease Activity Between Baseline of the Extension Study and Week 56 by Core Study Treatment Arm | Change in last interval with no disease activity | Extension study baseline, up to Week 56 |
| Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the 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 are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks. |
| Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term | 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 are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks. |
| Fort Lauderdale |
| Florida |
| 33309 |
| United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46280 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55435 | United States |
| Novartis Investigative Site | Germantown | Tennessee | 38138 | United States |
| Novartis Investigative Site | Albury | New South Wales | 2640 | Australia |
| Novartis Investigative Site | Hurstville | New South Wales | 2220 | Australia |
| Novartis Investigative Site | Parramatta | New South Wales | 2150 | Australia |
| Novartis Investigative Site | Sydney | New South Wales | 2000 | Australia |
| Novartis Investigative Site | Glen Waverley | Victoria | 3150 | Australia |
| Novartis Investigative Site | Rowville | Victoria | 3179 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Hradec Králové | CZE | 500 05 | Czechia |
| Novartis Investigative Site | Prague | 100 34 | Czechia |
| Novartis Investigative Site | Prague | 12808 | Czechia |
| Novartis Investigative Site | Saint-Cyr-sur-Loire | Indre Et Loire | 37540 | France |
| Novartis Investigative Site | Lyon | Rhone | 69317 | France |
| Novartis Investigative Site | Bordeaux | 33000 | France |
| Novartis Investigative Site | Créteil | 94000 | France |
| Novartis Investigative Site | Marseille | F 13008 | France |
| Novartis Investigative Site | Montauban | 82000 | France |
| Novartis Investigative Site | Nantes | 44093 | France |
| Novartis Investigative Site | Paris | 75010 | France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Rueil-Malmaison | 92500 | France |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Jerusalem | 9112001 | Israel |
| Novartis Investigative Site | Ramat Gan | 52621 | Israel |
| Novartis Investigative Site | Ẕerifin | 6093000 | Israel |
| Novartis Investigative Site | Perugia | PG | 06100 | Italy |
| Novartis Investigative Site | Malacca | Melaka Malaysia | 75000 | Malaysia |
| Novartis Investigative Site | Batu Caves | Selangor | 68100 | Malaysia |
| Novartis Investigative Site | Shah Alam | Selangor | 40000 | Malaysia |
| Novartis Investigative Site | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Novartis Investigative Site | Nijmegen | 6525 EX | Netherlands |
| Novartis Investigative Site | Porto | 4099-001 | Portugal |
| Novartis Investigative Site | Vila Franca de Xira | 2600-009 | Portugal |
| Novartis Investigative Site | Bundang Gu | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Seoul | Seocho Gu | 06591 | South Korea |
| Novartis Investigative Site | Busan | 49241 | South Korea |
| Novartis Investigative Site | Daegu | 705703 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Seoul | 07301 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08022 | Spain |
| Novartis Investigative Site | Sant Cugat del Vallès | Catalonia | 08190 | Spain |
| Novartis Investigative Site | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Burjassot | Valencia | 46100 | Spain |
| Novartis Investigative Site | Barcelona | 08024 | Spain |
| Novartis Investigative Site | Barcelona | 08025 | Spain |
| Novartis Investigative Site | Córdoba | 14012 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Örebro | 701 85 | Sweden |
| Novartis Investigative Site | Västerås | 72189 | Sweden |
| Novartis Investigative Site | Binningen | 4102 | Switzerland |
| Novartis Investigative Site | Taipei | 103616 | Taiwan |
| Novartis Investigative Site | Taipei | 11217 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set composed of all subjects who received at least one dose of study treatment in the extension study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab 6 mg (Extension Study Total) | Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye | Number of subjects in every 4 weeks (q4w), every 8 weeks (q8w), every 12 weeks (q12w) and every 20 weeks (q20w) intervals at last interval with no disease activity up to Week 56. Last interval with no disease activity (number of weeks): Number of subjects at 20/16/12/8/4-weeks intervals up to Week 56 for the study eye in the extension study | Full Analyses Set. Subjects with at least two injections in the extension study | Posted | Count of Participants | Participants | Up to Week 56 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye | Best-Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. The average change in BCVA from Baseline of the extension study at Week 52 and Week 56 was estimated by an analysis of variance (ANOVA) with baseline age categories, baseline BCVA categories and treatment arm in the core study included as fixed effects. Last observation carried forward (LOCF) was used to impute missing BCVA values. | Full Analyses Set - Last Observation Carried Forward. Participants were analyzed according to the originally assigned treatment arm in the core study (CRTH258A2303, NCT04005352). | Posted | Mean | Standard Deviation | Letters read | Extension study baseline, average of Week 52 and Week 56 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye | Central Subfield Thickness (μm): Analysis of Variance (ANOVA) results for the average change from extension study Baseline at Week 52 and Week 56 for the study eye in the extension study by core study treatment arm. Central Subfield Thickness was assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Participants in the Full Analysis Set with a valid measurement for the outcome measure. Participants were analyzed according to the originally assigned treatment arm in the core study (CRTH258A2303, NCT04005352). | Posted | Mean | Standard Deviation | μm | Extension study baseline, average of Week 52 and Week 56 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number (%) of Subjects With Presence of IRF and/or SRF, and Sub-RPE Fluid in the Study Eye at Week 52 and Week 56 Overall and by Core Study Treatment Arm | Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) status in the central subfield as assessed by Spectral Domain Ocular Coherence Tomography (SD-OCT): Number (%) of subjects with presence of IRF and/or SRF, and sub-Retinal Pigment Epithelium (RPE) fluid in the study eye at Week 52 and Week 56 overall and by core study treatment arm | Full Analyses Set - for subjects with a valid measurement | Posted | Count of Participants | Participants | Weeks 52 and 56 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Last Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study by Core Study Randomized Treatment Arm | Duration of the last interval with no disease activity up to Week 52 by core study treatment arm. | Full Analyses Set - for Subjects with at least two injections in the extension study | Posted | Count of Participants | Participants | up to Week 56 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Maximal Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study | Duration of the maximal intervals with no disease activity up to Week 52 by core study treatment arm. | Full Analyses Set - for Subjects with at least two injections in the extension study | Posted | Count of Participants | Participants | up to Week 56 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number (%) of Subjects With Change in Duration of Last Interval With no Disease Activity Between Baseline of the Extension Study and Week 56 by Core Study Treatment Arm | Change in last interval with no disease activity | Full Analyses Set - for Subjects with at least two injections in the extension study | Posted | Count of Participants | Participants | Extension study baseline, up to Week 56 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the 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. | Full Analyses Set | Posted | Count of Participants | Participants | Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term | 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. | Full Analyses Set | Posted | Count of Participants | Participants | Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks. |
|
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | All Collected Deaths | On treatment death monitoring occurred after the first dose of study drug in the extension study until 30 days after the last administration of study drug for a maximum timeframe of approximately 56 weeks. Post-treatment death monitoring occurred greater than 30 days after the last administration of study drug. | Full Analyses Set | Posted | Count of Participants | Participants | On-treatment death reporting - from first dose until 30 days after last dose for a maximum timeframe of approximately 56 weeks. Post-treatment death reporting - greater than 30 days after the last dose of study drug. |
|
|
Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.
Adverse events and the death are reported in the Full Analysis Set that includes all participants who received at least one dose of study treatment in the extension study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brolucizumab 6mg | Brolucizumab 6mg | 1 | 248 | 26 | 248 | 58 | 248 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Retinal detachment - Fellow eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Retinal occlusive vasculitis - Study eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Uveitis - Study eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vitreal cells - Fellow eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vitreal cells - Study eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Whipple's disease | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract - Fellow eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cataract - Study eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eye pain - Study eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Visual acuity reduced - Study eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Intraocular pressure increased - Study eye | Investigations | MedDRA (26.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2023 | Feb 27, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| D057092 | Geographic Atrophy |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|
|
| 8 weeks |
|
| 4 weeks |
|
| Brolucizumab 6 mg (Extension Study Total) |
Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity. |
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