Trial Outcomes & Findings for Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD (NCT NCT03386474)

Last Updated: 2021-01-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

151 participants

Primary outcome timeframe

Up to Week 24

Results posted on

2021-01-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	107	43
Overall Study COMPLETED	106	42
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Death	1	0
Overall Study Adverse Event	0	1

Baseline Characteristics

Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brolucizumab - Overall Extension Study n=107 Participants 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.	Aflibercept n=43 Participants 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.	Total n=150 Participants Total of all reporting groups
Age, Continuous	80.6 years STANDARD_DEVIATION 8.63 • n=5 Participants	77.9 years STANDARD_DEVIATION 9.20 • n=7 Participants	79.8 years STANDARD_DEVIATION 8.85 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	22 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	21 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=5 Participants	37 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: 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.

Outcome measures

Outcome measures
Measure	Brolucizumab - Overall Extension Study n=107 Participants 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 Overall Last 6 Months From Core Study n=107 Participants AEs with a start date on or after the date of Core study Week 68 visit were counted	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.
Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events Ocular AEs	20 Participants	25 Participants	—
Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events Non-Ocular AEs	51 Participants	50 Participants	—

SECONDARY outcome

Timeframe: Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Brolucizumab - Overall Extension Study n=62 Participants 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 Overall Last 6 Months From Core Study n=45 Participants AEs with a start date on or after the date of Core study Week 68 visit were counted	Brolucizumab - Overall Extension Study n=107 Participants 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.
Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit exWeek 4 (>=15 letters loss)	2 Number of Participants	0 Number of Participants	2 Number of Participants
Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit exWeek 8 (>=15 letters loss)	4 Number of Participants	0 Number of Participants	4 Number of Participants
Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit exWeek 12 (>=15 letters loss)	4 Number of Participants	0 Number of Participants	4 Number of Participants
Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit exWeek 16 (>=15 letters loss)	6 Number of Participants	0 Number of Participants	6 Number of Participants
Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit exWeek 20 (>=15 letters loss)	4 Number of Participants	0 Number of Participants	4 Number of Participants
Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit exWeek 24 (>=15 letters loss)	3 Number of Participants	0 Number of Participants	3 Number of Participants

SECONDARY outcome

Timeframe: Extension baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Brolucizumab - Overall Extension Study n=62 Participants 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 Overall Last 6 Months From Core Study n=45 Participants AEs with a start date on or after the date of Core study Week 68 visit were counted	Brolucizumab - Overall Extension Study n=107 Participants 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.
Change in BCVA From Extension Baseline at Each Post-baseline Visit exWeek 4	-1.3 Letter read Standard Deviation 6.26	0.5 Letter read Standard Deviation 3.81	-0.5 Letter read Standard Deviation 5.42
Change in BCVA From Extension Baseline at Each Post-baseline Visit exWeek 8	-1.7 Letter read Standard Deviation 6.90	-0.4 Letter read Standard Deviation 4.29	-1.2 Letter read Standard Deviation 5.96
Change in BCVA From Extension Baseline at Each Post-baseline Visit exWeek 12	-2.7 Letter read Standard Deviation 7.73	-0.3 Letter read Standard Deviation 5.17	-1.7 Letter read Standard Deviation 6.84
Change in BCVA From Extension Baseline at Each Post-baseline Visit exWeek 16	-3.9 Letter read Standard Deviation 8.42	0.8 Letter read Standard Deviation 5.36	-1.9 Letter read Standard Deviation 7.63
Change in BCVA From Extension Baseline at Each Post-baseline Visit exWeek 20	-3.4 Letter read Standard Deviation 7.66	0.5 Letter read Standard Deviation 7.34	-1.8 Letter read Standard Deviation 7.75
Change in BCVA From Extension Baseline at Each Post-baseline Visit exWeek 24	-2.0 Letter read Standard Deviation 8.17	0.3 Letter read Standard Deviation 6.79	-1.0 Letter read Standard Deviation 7.67

SECONDARY outcome

Timeframe: Week 20

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Brolucizumab - Overall Extension Study n=62 Participants 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 Overall Last 6 Months From Core Study n=45 Participants AEs with a start date on or after the date of Core study Week 68 visit were counted	Brolucizumab - Overall Extension Study n=107 Participants 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.
Patients With Positive q12w Treatment Status at Week 20	63.3 Percentage of patients	63.1 Percentage of patients	63.3 Percentage of patients

SECONDARY outcome

Timeframe: Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

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).

Outcome measures

Outcome measures
Measure	Brolucizumab - Overall Extension Study n=62 Participants 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 Overall Last 6 Months From Core Study n=45 Participants AEs with a start date on or after the date of Core study Week 68 visit were counted	Brolucizumab - Overall Extension Study n=107 Participants 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.
Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit exWeek 4	-19.2 micrometer Standard Deviation 39.29	-17.5 micrometer Standard Deviation 40.76	-18.5 micrometer Standard Deviation 39.74
Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit exWeek 8	-6.3 micrometer Standard Deviation 25.47	-18.9 micrometer Standard Deviation 31.74	-11.6 micrometer Standard Deviation 28.82
Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit exWeek 12	-17.9 micrometer Standard Deviation 43.07	-28.9 micrometer Standard Deviation 48.80	-22.5 micrometer Standard Deviation 45.66
Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit exWeek 16	-7.8 micrometer Standard Deviation 31.94	-11.7 micrometer Standard Deviation 39.83	-9.4 micrometer Standard Deviation 35.35
Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit exWeek 20	-10.1 micrometer Standard Deviation 59.04	-15.3 micrometer Standard Deviation 46.20	-12.3 micrometer Standard Deviation 53.84
Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit exWeek 24	-19.8 micrometer Standard Deviation 37.67	-24.6 micrometer Standard Deviation 42.10	-21.8 micrometer Standard Deviation 39.47

SECONDARY outcome

Timeframe: Extension Baseline, Week 8, Week 16, Week 24

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Brolucizumab - Overall Extension Study n=107 Participants 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 Overall Last 6 Months From Core Study AEs with a start date on or after the date of Core study Week 68 visit were counted	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.
Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status for Brolucuzumab 6 mg in Extension	54 Percentage of participants	—	—

Adverse Events

Brolucizumab 6mg Overall Extension Study

Serious events: 7 serious events

Other events: 12 other events

Deaths: 1 deaths

Brolucizumab Overall Last 6 Months Core Study

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Aflibercept 2 mg

Serious events: 10 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Brolucizumab 6mg Overall Extension Study n=107 participants at risk 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 Overall Last 6 Months Core Study n=107 participants at risk AEs with a start date on or after the date of Core study Week 68 visit were counted.	Aflibercept 2 mg n=43 participants at risk 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.
Eye disorders Cataract - Fellow eye	0.93% 1/107 • 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.	0.93% 1/107 • 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.	7.0% 3/43 • 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.
Eye disorders Neovascular age-related macular degeneration - Fellow eye	1.9% 2/107 • 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.	1.9% 2/107 • 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.	7.0% 3/43 • 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.
Infections and infestations Nasopharyngitis	4.7% 5/107 • 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.	3.7% 4/107 • 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.	7.0% 3/43 • 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.
Infections and infestations Urinary tract infection	3.7% 4/107 • 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.	5.6% 6/107 • 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.	14.0% 6/43 • 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.
Renal and urinary disorders Haematuria	0.00% 0/107 • 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.	0.93% 1/107 • 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.	7.0% 3/43 • 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.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER