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The purpose of this extension study was to assess the safety and efficacy of the new formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The medical condition treated in the core and extension trials was neo-vascular age-related macular degeneration (nAMD).
Subjects in the United States who had completed the 96 week core trial, CRTH258A2301 (also referred as CRTH258-C002), were eligible to participate in the extension trial provided the core trial Visit 26 at week 96, was less than or equal to 12 weeks from the Baseline Visit in the extension trial, CRTH258A2301E1.
Subjects who were treated with aflibercept during the core trial and met the eligibility requirements of this extension trial continued to receive aflibercept in this extension trial in order to maintain the masking during the extension trial. No hypothesis testing or descriptive analyses were planned.
Subjects who were treated in the core trial with brolucizumab 3mg or brolucizumab 6 mg, and met the eligibility requirements of this extension trial, received the new formulation of brolucizumab 6 mg solution in the extension trial.
Enrolled subjects were to receive three intravitreal (IVT) ophthalmic injections. The study eye was the same eye that received the treatment in the core study. The extension trial consisted of 7 study visits at 4 week intervals over a period of 24 weeks.
Assessment of the efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding core-study efficacy and safety data serving as the reference. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab | Experimental | Brolucizumab 6 mg solution for IVT injection, single injection at Day 1 (baseline), Week 8, and Week 16 or Week 20 |
|
| Aflibercept | Other | Aflibercept 2 mg solution for IVT injection, single injection at Day 1 (baseline), Week 8 and Week 16 to maintain the masking of the extension trial only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab 6 mg | Drug | Administered as opthalmic solution for an intravitreal injection to the study eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events | Number of participants with ocular and non-ocular treatment emergent events with the new formulation brolucizumab 6 mg in this extension trial up to week 24 vs. the corresponding last 6 months of brolucizumab treatment in the Core trial >= 2%. Safety assessment of the new formulation brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding Core safety data. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit | Best-corrected visual acuity for the study eye was tested at all study visits in a sitting position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Outcome measure was prespecified for brolucizumab arm only. Neither patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data presented descriptively for only brolucizumab in line with study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Peoria | Arizona | 85381 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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150 subjects who completed the 96 week CORE trial (RTH258-C001) were eligible to continue in the extension. 62 CORE sub. were treated w/ brolucizumab 3mg & 45 CORE sub. w/ brolucizumab 6mg. These 107 sub. were treated in the extension w/ new formulation 6 mg brolucizumab. 43 subjects treated with aflibercept 2 mg in the CORE continued aflibercept.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brolucizumab - Overall Extension Study | Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
| FG001 |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2018 | Oct 10, 2019 |
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| Aflibercept 2 mg | Drug | Administered as an opthalmic solution for intravitreal injection to the study eye |
|
|
| Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Change in BCVA From Extension Baseline at Each Post-baseline Visit | Best-corrected visual acuity for the study eye was tested at all study visits in a sitting position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Extension baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Patients With Positive q12w Treatment Status at Week 20 | The estimate for the proportion of patients with a positive q12w treatment status at Week 24 was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need'. The outcome of the Kaplan-Meier analysis was estimated probability for maintaining on q12w up to the Disease Activity Assessment (DAA) at exWeek 20. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Week 20 |
| Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit | Measurement of the central subfield thickness of the retina was assessed using Optical Coherence Tomography (OCT) at each visit for the study eye. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status for Brolucuzumab 6 mg in Extension | Positive integrated anti-drug antibodies (ADA) status is defined as induced ADA status with ADA negative at pre-dose and a post-dose titer value of greater than or equal to 30 at any time point or boosted ADA status with ADA positive at pre-dose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Extension Baseline, Week 8, Week 16, Week 24 |
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Novartis Investigative Site | Arcadia | California | 91006 | United States |
| Novartis Investigative Site | Huntington Beach | California | 92647 | United States |
| Novartis Investigative Site | La Jolla | California | 92093 | United States |
| Novartis Investigative Site | Loma Linda | California | 92354 | United States |
| Novartis Investigative Site | Mountain View | California | 94040 | United States |
| Novartis Investigative Site | Oakland | California | 94609 | United States |
| Novartis Investigative Site | Redlands | California | 92374 | United States |
| Novartis Investigative Site | Sacramento | California | 95841 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80909 | United States |
| Novartis Investigative Site | Golden | Colorado | 80401 | United States |
| Novartis Investigative Site | Bridgeport | Connecticut | 06606 | United States |
| Novartis Investigative Site | New London | Connecticut | 06320 | United States |
| Novartis Investigative Site | Altamonte Springs | Florida | 32701 | United States |
| Novartis Investigative Site | Deerfield Beach | Florida | 33064 | United States |
| Novartis Investigative Site | Fort Myers | Florida | 33912-7125 | United States |
| Novartis Investigative Site | Ocala | Florida | 34474 | United States |
| Novartis Investigative Site | Palm Beach Gardens | Florida | 33410 | United States |
| Novartis Investigative Site | Pensacola | Florida | 32503 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34239 | United States |
| Novartis Investigative Site | Tallahassee | Florida | 32308 | United States |
| Novartis Investigative Site | Vero Beach | Florida | 32960 | United States |
| Novartis Investigative Site | Winter Haven | Florida | 33880 | United States |
| Novartis Investigative Site | Boise | Idaho | 83713 | United States |
| Novartis Investigative Site | Bloomington | Illinois | 61704 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46280 | United States |
| Novartis Investigative Site | Leawood | Kansas | 66211 | United States |
| Novartis Investigative Site | Shawnee Mission | Kansas | 66204 | United States |
| Novartis Investigative Site | Portland | Maine | 04102 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21237-4350 | United States |
| Novartis Investigative Site | Waldorf | Maryland | 20602 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89144 | United States |
| Novartis Investigative Site | Reno | Nevada | 89502 | United States |
| Novartis Investigative Site | Toms River | New Jersey | 08755 | United States |
| Novartis Investigative Site | Albuquerque | New Mexico | 87102 | United States |
| Novartis Investigative Site | Rochester | New York | 14620 | United States |
| Novartis Investigative Site | Rochester | New York | 14642 | United States |
| Novartis Investigative Site | Shirley | New York | 11967 | United States |
| Novartis Investigative Site | Syracuse | New York | 13224 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28210 | United States |
| Novartis Investigative Site | Southern Pines | North Carolina | 28387 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44122 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44195 | United States |
| Novartis Investigative Site | Dublin | Ohio | 43016 | United States |
| Novartis Investigative Site | Fairfield | Ohio | 45014 | United States |
| Novartis Investigative Site | Camp Hill | Pennsylvania | 17011 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | Abilene | Texas | 79606 | United States |
| Novartis Investigative Site | Austin | Texas | 78731 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | United States |
| Novartis Investigative Site | Houston | Texas | 77025 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Plano | Texas | 75093 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78215 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78240 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23235 | United States |
| Novartis Investigative Site | Warrenton | Virginia | 20186 | United States |
| Novartis Investigative Site | Silverdale | Washington | 98383 | United States |
| Novartis Investigative Site | Spokane | Washington | 99204 | United States |
| Novartis Investigative Site | University Place | Washington | 98467 | United States |
| Novartis Investigative Site | Morgantown | West Virginia | 26506 | United States |
| Novartis Investigative Site | Milwaukee | Wisconsin | 53226 | United States |
| Novartis Investigative Site | Arecibo | 00612 | Puerto Rico |
| Novartis Investigative Site | San Juan | 00907 | Puerto Rico |
| Aflibercept |
Subjects previously treated with aflibercept 2 mg in the Core study continued to receive aflibercept 2mg IVT injection at the extension Baseline, Week 8 and Week 16 to maintain the masking in the extension trial. |
| COMPLETED | Completed exWeek 24 |
|
| NOT COMPLETED |
|
|
The Extension safety set includes all subjects who entered the extension study and received at least one injection of study treatment in this extension study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab - Overall Extension Study | Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
| BG001 | Aflibercept | Subjects previously treated with aflibercept 2 mg in the Core study continued to receive aflibercept 2mg IVT injection at the extension Baseline, Week 8 and Week 16 to maintain the masking in the extension trial. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (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 | Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events | Number of participants with ocular and non-ocular treatment emergent events with the new formulation brolucizumab 6 mg in this extension trial up to week 24 vs. the corresponding last 6 months of brolucizumab treatment in the Core trial >= 2%. Safety assessment of the new formulation brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding Core safety data. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Brolucizumab extension safety set included subjects who received at least one injection of brolucizumab 6mg. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. | Posted | Number | Participants | Up to Week 24 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit | Best-corrected visual acuity for the study eye was tested at all study visits in a sitting position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Outcome measure was prespecified for brolucizumab arm only. Neither patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data presented descriptively for only brolucizumab in line with study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of the efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding core study efficacy data serving as the reference. | Posted | Number | Number of Participants | Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in BCVA From Extension Baseline at Each Post-baseline Visit | Best-corrected visual acuity for the study eye was tested at all study visits in a sitting position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of the efficacy of brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding core-study efficacy and safety data serving as the reference. | Posted | Mean | Standard Deviation | Letter read | Extension baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Patients With Positive q12w Treatment Status at Week 20 | The estimate for the proportion of patients with a positive q12w treatment status at Week 24 was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need'. The outcome of the Kaplan-Meier analysis was estimated probability for maintaining on q12w up to the Disease Activity Assessment (DAA) at exWeek 20. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of the efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with last 6 months of corresponding core-study efficacy data serving as reference. | Posted | Number | Percentage of patients | Week 20 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit | Measurement of the central subfield thickness of the retina was assessed using Optical Coherence Tomography (OCT) at each visit for the study eye. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of the efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding core-study efficacy data serving as the reference. | Posted | Mean | Standard Deviation | micrometer | Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status for Brolucuzumab 6 mg in Extension | Positive integrated anti-drug antibodies (ADA) status is defined as induced ADA status with ADA negative at pre-dose and a post-dose titer value of greater than or equal to 30 at any time point or boosted ADA status with ADA positive at pre-dose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF). | Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with last 6 months of corresponding core-study efficacy data serving as the reference. | Posted | Number | Percentage of participants | Extension Baseline, Week 8, Week 16, Week 24 |
|
From first treatment in the extension study, through study completion, to an average of 24 weeks. Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 6 months.
Adverse events were recorded for AEs that started during the extension study, and AEs started during the Core study that were ongoing at ext. baseline. Safety assessment of broluizumab 6 mg was based on a within-patient comparison w/the last 6 months of corresponding Core safety data serving as reference. Adverse Events were obtained from subjects and observations by the Investigator as outlined in the study protocol. This analysis set includes all subjects who received at least 1 IVT injection.
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 Overall Extension Study | Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. | 1 | 107 | 7 | 107 | 12 | 107 |
| EG001 | Brolucizumab Overall Last 6 Months Core Study | AEs with a start date on or after the date of Core study Week 68 visit were counted. | 0 | 107 | 7 | 107 | 14 | 107 |
| EG002 | Aflibercept 2 mg | Subjects previously treated with aflibercept 2 mg in the Core study continued to receive aflibercept 2mg IVT injection at the extension Baseline, Week 8 and Week 16 to maintain the masking in the extension trial. | 0 | 43 | 10 | 43 | 13 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Retinal artery occlusion - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Retinal vein occlusion - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract - Fellow eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 5, 2017 | Oct 10, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Brolucizumab 6 mg - 6 mg in Core Study |
Subjects treated with brolucizumab 6 mg in Core study and given new formulation 6 mg in Extension study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
| OG002 | Brolucizumab - Overall Extension Study | Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
|
|
| Brolucizumab 6 mg - 6 mg in Core Study |
Subjects treated with brolucizumab 6 mg in Core study and given new formulation 6 mg in Extension study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
| OG002 | Brolucizumab - Overall Extension Study | Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
|
|
| Brolucizumab 6 mg- 6 mg in Core Study |
Subjects treated with brolucizumab 6 mg in Core study and given new formulation 6 mg in Extension study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
| OG002 | Brolucizumab - Overall Extension Study | Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
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Subjects treated with brolucizumab 6 mg in Core study and given new formulation 6 mg in Extension study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
| OG002 | Brolucizumab - Overall Extension Study | Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20. |
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| Participants |
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