Trial Outcomes & Findings for A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration (NCT NCT04239027)

Last Updated: 2024-10-09

Results Overview

OCT-A is a dye-less angiographic procedure based on split-spectrum-decorrelation-amplitude angiography. It enables the capture of scattered intra-vessel particles (mainly erythrocyte cells) at all levels of the retinal and inner-choroidal vasculature, thus providing 3-D imaging of the retinal circulation. The literature suggests that OCT-A is a good marker for assessing anti-VEGF therapeutic response, especially lesion size. Inter-Quartile Range = q1 - q3.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

210 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2024-10-09

Participant Flow

210 adult patients were treated at 40 centers in France. The maximum study duration for 1 patient was 48 weeks.

The Screening/Baseline visit were performed on the same Visit (Day 1). The first dose of study treatment was also administered on Day 1.

Participant milestones

Participant milestones
Measure	RTH258/Brolucizumab This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Overall Study STARTED	210
Overall Study COMPLETED	184
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	RTH258/Brolucizumab This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	9
Overall Study Death	1
Overall Study Physician Decision	9
Overall Study Lost to Follow-up	2
Overall Study Lack of Efficacy	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RTH258/Brolucizumab n=210 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Age, Categorical <=18 years	0 Participants n=210 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=210 Participants
Age, Categorical >=65 years	200 Participants n=210 Participants
Age, Continuous	77.8 years STANDARD_DEVIATION 7.17 • n=210 Participants
Sex: Female, Male Female	129 Participants n=210 Participants
Sex: Female, Male Male	81 Participants n=210 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Participants in the Full Analysis Set (FAS) with a valid value for the outcome measure. The FAS is comprised of all treated patients. Due to ungradable images and other reasons, only 138 patients were evaluable at Week 12 for choroidal neovascularization (CNV) lesion area by optical coherence tomography-angiography (OCT-A) in nAMD. This sample size of 138 patients was reassessed and shown to be valid for analysis of the primary efficacy endpoint.

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=138 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Percentage Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 12	-79.29 % change from baseline Interval -100.0 to -11.19

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 48

Population: Participants in the Full Analysis Set (FAS) with a valid value for the outcome measure at baseline and at each timepoint. The FAS comprised all patients to whom study treatment had been assigned and who received at least one IVT injection of study treatment.

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=124 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Percentage Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Week 4 (n=124)	-59.03 % change from baseline Interval -100.0 to -6.34
Percentage Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Week 8 (n=109)	-53.41 % change from baseline Interval -100.0 to -0.67
Percentage Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Week 48 (n=117)	-68.50 % change from baseline Interval -100.0 to -1.4

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 48

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=140 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Week 4 (n=126)	-0.09 square millimeters Interval -0.34 to 0.0
Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Week 8 (n=111)	-0.12 square millimeters Interval -0.47 to 0.0
Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Week 12 (n=140)	-0.14 square millimeters Interval -0.5 to -0.01
Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Week 48 (n=122)	-0.08 square millimeters Interval -0.35 to 0.0

SECONDARY outcome

Timeframe: Baseline, Week 48

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=153 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Present CNV at baseline and Present CNV at Week 48	66 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Present CNV at baseline and Not Present CNV at Week 48	48 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Present CNV at baseline and Ungradable at Week 48	6 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Not Present CNV at Baseline and Present CNV at Week 48	5 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Not Present CNV at Baseline and Not Present CNV at Week 48	4 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Not Present CNV at Baseline and Ungradable at Week 48	1 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Ungradable at Baseline and Present CNV at Week 48	8 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Ungradable at Baseline and Not Present CNV at Week 48	14 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Ungradable at Baseline and Ungradable at Week 48	1 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Total at Baseline and Present CNV at Week 48	79 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Total at Baseline and Not Present CNV at Week 48	66 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Total at Baseline and Ungradable at Week 48	8 Participants
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48 Total at Baseline and Total at Week 48	153 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 48

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=199 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Change in Best Corrected Visual Acuity (BCVA) From Baseline up to Week 48 Week 4 (n=174)	5.0 ETDRS letters read Standard Deviation 7.48
Change in Best Corrected Visual Acuity (BCVA) From Baseline up to Week 48 Week 8 (n=153)	6.7 ETDRS letters read Standard Deviation 8.07
Change in Best Corrected Visual Acuity (BCVA) From Baseline up to Week 48 Week 12 (n=199)	6.7 ETDRS letters read Standard Deviation 9.09
Change in Best Corrected Visual Acuity (BCVA) From Baseline up to Week 48 Week 48 (n=158)	8.3 ETDRS letters read Standard Deviation 12.03

SECONDARY outcome

Timeframe: Weeks 20, 32, 44, 48

Population: FAS

To estimate the proportion of patients treated at q12w frequency with brolucizumab.

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=210 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Percentage of Patients Who Are Maintained on an Exclusive Treatment Interval Every 12 Weeks (q12w) Following the Loading Phase to Week 48 % of patients with exclusive q12w dose - Week 20	74.5 % of Participants Interval 66.8 to 81.2
Percentage of Patients Who Are Maintained on an Exclusive Treatment Interval Every 12 Weeks (q12w) Following the Loading Phase to Week 48 % of patients with exclusive q12w dose - Week 32	55.6 % of Participants Interval 47.3 to 63.6
Percentage of Patients Who Are Maintained on an Exclusive Treatment Interval Every 12 Weeks (q12w) Following the Loading Phase to Week 48 % of patients with exclusive q12w dose - Week 44	42.5 % of Participants Interval 34.5 to 50.7
Percentage of Patients Who Are Maintained on an Exclusive Treatment Interval Every 12 Weeks (q12w) Following the Loading Phase to Week 48 % of patients with exclusive q12w dose - Week 48	42.5 % of Participants Interval 34.5 to 50.7

SECONDARY outcome

Timeframe: Weeks 0,4,5,8,9,15,16,17,18,20,21,22,24,32,33,34,35,40,41,43,44,48

Population: FAS

To estimate the predictive value of the first q12w cycle for maintenance of q12w treatment with brolucizumab via the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=210 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 9 (n=184)	1 Probability of Q12 maintain Interval 1.0 to 1.0
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 0	1 Probability of Q12 maintain Interval 1.0 to 1.0
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 4 (n=201)	1 Probability of Q12 maintain Interval 1.0 to 1.0
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 5 (n=198)	1 Probability of Q12 maintain Interval 1.0 to 1.0
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 8 (n=196)	1 Probability of Q12 maintain Interval 1.0 to 1.0
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 15 (n=176)	0.97 Probability of Q12 maintain Interval 0.933 to 0.988
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 16 (n=171)	0.78 Probability of Q12 maintain Interval 0.716 to 0.838
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 17 (n=138)	0.66 Probability of Q12 maintain Interval 0.59 to 0.729
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 18 (n=117)	0.65 Probability of Q12 maintain Interval 0.572 to 0.713
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 20 (n=114)	0.57 Probability of Q12 maintain Interval 0.492 to 0.638
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 21 (n=97)	0.51 Probability of Q12 maintain Interval 0.433 to 0.581
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 22 (n=87)	0.5 Probability of Q12 maintain Interval 0.427 to 0.575
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 24 (n=86)	0.5 Probability of Q12 maintain Interval 0.422 to 0.569
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 32 (n=85)	0.47 Probability of Q12 maintain Interval 0.393 to 0.54
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 33 (n=80)	0.46 Probability of Q12 maintain Interval 0.382 to 0.529
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 34 (n=78)	0.45 Probability of Q12 maintain Interval 0.376 to 0.523
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 35 (n=77)	0.45 Probability of Q12 maintain Interval 0.376 to 0.523
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 40 (n=76)	0.45 Probability of Q12 maintain Interval 0.376 to 0.523
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 41 (n=72)	0.45 Probability of Q12 maintain Interval 0.376 to 0.523
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 43 (n=71)	0.45 Probability of Q12 maintain Interval 0.376 to 0.523
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 44 (n=65)	0.45 Probability of Q12 maintain Interval 0.376 to 0.523
The Probability of the First q12w Interval for Determining Successful q12w Maintenance Week 48 (n=65)	0.45 Probability of Q12 maintain Interval 0.376 to 0.523

SECONDARY outcome

Timeframe: Week 8 until Week 41

Population: Full analysis set

To evaluate the time from last IVT injection in the initiation phase to first visit with no disease activity. The 95% CI are estimated by using the Greenwood formula Kaplan-Meier (KM) method.

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=210 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 8	0.83 Probability of no disease activity Interval 0.77 to 0.88
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 9	0.85 Probability of no disease activity Interval 0.79 to 0.9
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 10	0.86 Probability of no disease activity Interval 0.8 to 0.91
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 15	0.86 Probability of no disease activity Interval 0.8 to 0.91
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 16	0.87 Probability of no disease activity Interval 0.81 to 0.92
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 18	0.88 Probability of no disease activity Interval 0.82 to 0.93
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 23	0.89 Probability of no disease activity Interval 0.83 to 0.94
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 24	0.9 Probability of no disease activity Interval 0.84 to 0.95
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 31	0.9 Probability of no disease activity Interval 0.84 to 0.95
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 32	0.93 Probability of no disease activity Interval 0.87 to 0.97
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 33	0.94 Probability of no disease activity Interval 0.88 to 0.98
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 35	0.96 Probability of no disease activity Interval 0.9 to 0.99
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 36	0.96 Probability of no disease activity Interval 0.9 to 0.99
Time From Last Intravitreal (IVT) Injection in the Initiation Phase to First Visit With no Disease Activity - Probability of no Disease Activity Week 41	0.96 Probability of no disease activity Interval 0.9 to 0.99

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 48

Central sub-field thickness (CSFT) was measured by Spectral Domain Optical Coherence Tomography (SD-OCT). The CSFT evaluated in this study represents the average retinal thickness of the circular area within 1 mm diameter around the foveal center. SD-OCT images were obtained and assessed in the study eye by SD-OCT machines. (i.e. no time-domain nor swept-source OCT).

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=188 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Change From Baseline up to Week 48 in SD-OCT Assessed by Qualitative and Quantitative Criteria: Central Sub-Field Retinal Thickness (CSFT) Week 4 (n=164)	-131.79 μm Standard Deviation 109.100
Change From Baseline up to Week 48 in SD-OCT Assessed by Qualitative and Quantitative Criteria: Central Sub-Field Retinal Thickness (CSFT) Week 8 (n=143)	-152.95 μm Standard Deviation 128.031
Change From Baseline up to Week 48 in SD-OCT Assessed by Qualitative and Quantitative Criteria: Central Sub-Field Retinal Thickness (CSFT) Week 12 (n=188)	-150.51 μm Standard Deviation 126.931
Change From Baseline up to Week 48 in SD-OCT Assessed by Qualitative and Quantitative Criteria: Central Sub-Field Retinal Thickness (CSFT) Week 48 (n=150)	-151.09 μm Standard Deviation 134.684

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 48

Population: FAS

To evaluate the effect of brolucizumab on anatomical parameters as assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Fluorescein Angiography (FA). RPE = Retinal Pigmented Epithelium IRF = Intraretinal Fluid SRF = Subretinal Fluid Sub-RPE = Sub Retinal Pigmented Epithelium

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=201 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Baseline Intraretinal fluid	101 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Baseline Subretinal fluid	169 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Baseline Sub-RPE fluid	60 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Baseline Without any fluid (IRF/SRF)	8 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Baseline With any fluid (IRF/SRF)	193 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 4 Intraretinal fluid (n=174 )	39 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 4 Subretinal fluid (n=174 )	69 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 4 Sub-RPE fluid (n=174 )	47 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 4 Without any fluid (IRF/SRF) (n=174 )	84 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 4 With any fluid (IRF/SRF) (n=174 )	90 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 8 Intraretinal fluid (n=155)	31 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 8 Subretinal fluid (n=155)	28 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 8 Sub-RPE fluid (n=155)	50 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 8 Without any fluid (IRF/SRF) (n=155)	108 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 8 With any fluid (IRF/SRF) (n=155)	44 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 12 Intraretinal fluid (n=197)	51 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 12 Subretinal fluid (n=197)	38 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 12 Sub-RPE fluid (n=197)	19 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 12 Without any fluid (IRF/SRF) (n=197)	120 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 12 With any fluid (IRF/SRF) (n=197)	74 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 48 Intraretinal fluid (n=159)	38 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 48 Subretinal fluid (n=159)	26 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 48 Sub-RPE fluid (n=159)	19 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 48 Without any fluid (IRF/SRF) (n=159)	99 Participants
Change From Baseline up to Week 48 in SD-OCT and FA Features Assessed by Qualitative and Quantitative Criteria: Sub and Intraretinal Fluid, Sub-RPE (Retinal Pigmented Epithelium) - Study Eye Week 48 With any fluid (IRF/SRF) (n=159)	60 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Set

An 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.

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=210 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. SAEs - Treatment-related - Ocular	7 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any Adverse Event (AE) - Ocular	95 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any AE - Treatment-related - Ocular	32 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any AE - Procedure-related - Ocular	18 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Serious Adverse events (SAE) - Ocular	8 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. SAEs - Procedure-related -Ocular	1 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - Treatment-related - Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - Procedure-related - Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment discontinuation - Ocular	25 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment disc - Treatment-related - Ocular	25 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment disc - Procedure-related - Ocular	6 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption - Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption -Treatment-related - Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption - Procedure-related - Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any Adverse Event - Non-Ocular	77 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any AE - Treatment-related - Non-Ocular	1 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any AE - Procedure-related - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Serious Adverse events (SAE) - Non-Ocular	13 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. SAEs - Treatment-related - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. SAEs - Procedure-related - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - Non-Ocular	1 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - Treatment-related - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - Procedure-related - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment discontinuation - Non-Ocular	3 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment disc - Treatment-related - Non-Ocular	1 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment disc - Procedure-related - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption - Treatment-related - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption - Procedure-related - Non-Ocular	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any Adverse Event - All patients	135 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any AE - Treatment-related - All patients	33 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Any AE - Procedure-related All patients	18 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Serious Adverse events (SAE) - All patients	20 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. SAEs - Treatment-related - All patients	7 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. SAEs - Procedure-related - All patients	1 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - All patients	1 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - Treatment-related - All patients	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. Fatal SAEs - Procedure-related - All patients	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment discontinuation - All patients	28 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment disc - Treatment-related - All patients	26 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to treatment disc - Procedure-related - All patients	6 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption - All patients	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption - Treatment-related - All patients	0 Participants
Incidence of Adverse Events (AEs) (Serious and Nonserious) Reported in Patients Treated With Brolucizumab. AEs leading to interruption - Procedure-related - All patients	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Set

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=210 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Eye pain	10 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Vitritis	10 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Dry eye	9 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Vitreous floaters	8 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Vision blurred	6 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Visual acuity reduced	6 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Cataract	5 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Ocular hypertension	5 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal haemorrhage	5 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Uveitis	5 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Keratitis	4 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Conjunctival haemorrhage	3 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Eye pruritus	3 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Iridocyclitis	3 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye -Lacrimation increased	3 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal pigment epithelial tear	3 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal vasculitis	3 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Vitreous detachment	3 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Blepharitis	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Metamorphopsia	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Ocular discomfort	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Ocular vasculitis	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Photophobia	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Punctate keratitis	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal degeneration	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal occlusive vasculitis	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Serous retinal detachment	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Visual field defect	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Anterior chamber cell	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Anterior chamber inflammation	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Conjunctivitis allergic	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Detachment of macular retinal pigment epithelium	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Diplopia	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Eye inflammation	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Eye irritation	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Foreign body sensation in eyes	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Ocular hyperaemia	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Periorbital pain	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Photopsia	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Posterior capsule opacification	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal fibrosis	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal neovascularisation	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal oedema	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Retinal perivascular sheathing	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Vitreoretinal traction syndrome	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Vitreous haze	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye Immune system disorders	2 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Drug hypersensitivity	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Seasonal allergy	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye Infections and infestations	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Conjunctivitis	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye Injury, poisoning and procedural complications	3 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Foreign body in eye	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Postoperative hypertension	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Procedural pain	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye Investigations	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye - Intraocular pressure increased	1 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye Eye disorders	81 Participants
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab, by Primary System Organ Class (SOC) and Preferred Term (PT) - Ocular Adverse Events in Study Eye Number of patients with at least one AE	85 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Set

Outcome measures

Outcome measures
Measure	RTH258/Brolucizumab n=210 Participants This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Incidence of AEs (Serious and Nonserious) Reported in Patients Treated With Brolucizumab - Non-Ocular Adverse Events	77 Participants

Adverse Events

RTH258/Brolucizumab

Serious events: 20 serious events

Other events: 130 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	RTH258/Brolucizumab n=210 participants at risk This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Cardiac disorders Aortic valve incompetence	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Cardiac disorders Cardiac failure	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Cardiac disorders Myocardial infarction	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eye haematoma - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Iridocyclitis - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Uveitis - Study eye	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vitritis - Study eye	1.9% 4/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Autoimmune pancreatitis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Diarrhoea	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Vomiting	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Hepatobiliary disorders Cholelithiasis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Fall	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Femoral neck fracture	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Cerebrovascular accident	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Renal and urinary disorders Urinary retention	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Vascular disorders Aortic dissection	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Vascular disorders Hypertension	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Vascular disorders Peripheral artery stenosis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.

Other adverse events

Other adverse events
Measure	RTH258/Brolucizumab n=210 participants at risk This is a single-arm study in which all patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
Musculoskeletal and connective tissue disorders Tendonitis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ear neoplasm malignant	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Balance disorder	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Cerebral ischaemia	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Cognitive disorder	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Dizziness	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Headache	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Ischaemic stroke	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Leukoencephalopathy	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Paraesthesia	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Retinal migraine	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders Sciatica	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Nervous system disorders White matter lesion	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Psychiatric disorders Depression	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Psychiatric disorders Insomnia	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Renal and urinary disorders Nephrolithiasis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Renal and urinary disorders Renal failure	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Skin and subcutaneous tissue disorders Rash erythematous	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Skin and subcutaneous tissue disorders Skin disorder	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Skin and subcutaneous tissue disorders Skin irritation	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Skin and subcutaneous tissue disorders Urticaria	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Vascular disorders Hypertension	4.3% 9/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Blood and lymphatic system disorders Anaemia	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Cardiac disorders Arrhythmia	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Cardiac disorders Arteriosclerosis coronary artery	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Cardiac disorders Cardiac failure	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Cardiac disorders Tachycardia	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Ear and labyrinth disorders Vertigo	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Age-related macular degeneration - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Anterior chamber cell - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Anterior chamber inflammation - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Blepharitis	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Blepharitis - Both eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Cataract - Both eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Cataract - Fellow eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Cataract - Study eye	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Chalazion	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Conjunctival haemorrhage - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Conjunctival haemorrhage - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Conjunctivitis allergic - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Detachment of macular retinal pigment epithelium - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Detachment of retinal pigment epithelium - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Diplopia - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Dry eye - Both eye	3.3% 7/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Dry eye - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eye inflammation - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eye irritation - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eye pain - Both eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eye pain - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eye pain - Study eye	3.8% 8/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eye pruritus - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eye pruritus - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eyelid ptosis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Eyelids pruritus	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Foreign body sensation in eyes - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Foreign body sensation in eyes - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Iridocyclitis - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Keratitis - Both eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Keratitis - Fellow eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Keratitis - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Lacrimation increased - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Lacrimation increased - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Lacrimation increased - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Metamorphopsia - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Neovascular age-related macular degeneration - Fellow eye	4.8% 10/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Ocular discomfort - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Ocular hyperaemia - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Ocular hypertension - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Ocular hypertension - Study eye	1.9% 4/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Ocular vasculitis - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Periorbital pain - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Photophobia - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Photophobia - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Photopsia - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Posterior capsule opacification - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Posterior capsule opacification - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Punctate keratitis - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal cyst - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal degeneration - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal fibrosis - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal haemorrhage - Both eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal haemorrhage - Study eye	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal neovascularisation - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal occlusive vasculitis - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal oedema - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal perivascular sheathing - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal pigment epithelial tear - Study eye	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Retinal vasculitis - Study eye	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Serous retinal detachment - Fellow eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Serous retinal detachment - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Swelling of eyelid	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Uveitis - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vision blurred - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vision blurred - Study eye	2.4% 5/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Visual acuity reduced - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Visual acuity reduced - Study eye	2.4% 5/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Visual field defect - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Visual field defect - Study eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vitreoretinal traction syndrome - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vitreous detachment - Study eye	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vitreous floaters - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vitreous floaters - Fellow eye	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vitreous floaters - Study eye	3.8% 8/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vitreous haze - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Eye disorders Vitritis - Study eye	2.9% 6/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Aerophagia	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Constipation	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Dental caries	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Dental cyst	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Diarrhoea	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Flatulence	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Gastrointestinal disorders Toothache	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
General disorders Fatigue	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
General disorders Pyrexia	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Hepatobiliary disorders Cholestasis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Immune system disorders Drug hypersensitivity	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Immune system disorders Drug hypersensitivity - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Immune system disorders Seasonal allergy - Both eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Bronchitis	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations COVID-19	3.8% 8/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Conjunctivitis - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Conjunctivitis - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Conjunctivitis viral - Fellow eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Gastroenteritis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Influenza	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Sinusitis	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Skin infection	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Tracheitis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Infections and infestations Urinary tract infection	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Arthropod bite	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Fall	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Foreign body in eye - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Hand fracture	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Head injury	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Joint injury	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Lip injury	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Postoperative hypertension - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Procedural pain - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Radius fracture	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Skeletal injury	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Injury, poisoning and procedural complications Wrist fracture	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Investigations Blood cholesterol increased	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Investigations Intraocular pressure increased - Study eye	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Investigations SARS-CoV-2 test positive	0.95% 2/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Metabolism and nutrition disorders Diabetes mellitus	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Metabolism and nutrition disorders Gout	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Metabolism and nutrition disorders Hypercholesterolaemia	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Metabolism and nutrition disorders Hyperglycaemia	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Metabolism and nutrition disorders Vitamin D deficiency	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 3/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Back pain	1.9% 4/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Muscle spasms	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.48% 1/210 • Adverse events are reported from first dose of study treatment plus 30 days post treatment (if last treatment was at Week 40) or 60 days post treatment (if last dose was at Week 44), for a maximum reporting period of 48 weeks.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 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 (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER