Neovascular Age-related Macular Degeneration (nAMD)
Conditions
Keywords
Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration, AMD, neovascular age-related macular degeneration, nAMD, retinal vein occlusion, RVO
Brief summary
The purpose of this study was to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) patients that more closely resemble the real-world population intended to be treated with brolucizumab. This study was conducted as part of the post-marketing regulatory commitment to the Indian Health authority.
Detailed description
The study was a prospective, multi-center, open-label, interventional phase IV clinical study. The study treatment, i.e., brolucizumab was prescribed in terms of the marketing authorization; the assignment of the patient to the therapy was decided within the current practice and the medical indication. It was clearly separated from the decision to include the patient in the study. All patients with Neovascular Age-related Macular Degeneration (nAMD) who were planned to be treated with brolucizumab and had provided informed consent were enrolled in the study. A total of 12 sites in India were evaluated for the study conduct. This is to note that site #03 was not selected, and site #07 was not initiated, and patients were enrolled in the study only from 10 sites. The treatment period for each patient was 56 weeks after the start of brolucizumab treatment. Study visits were scheduled at Week 4, Week 8, Week 16, and thereafter at intervals of 8 weeks or 12 weeks after disease activity assessment at Week 16. If the investigators required more frequent follow-up visits, it was done according to their discretion and clinical judgment. Any patient who suffered from IOI during the study period was not re-challenged with brolucizumab. The study population consisted of adult male and female outpatients aged 50 years and above, diagnosed with nAMD for whom the treating the physician (Investigator) had prescribed treatment with brolucizumab 6 mg injection in adherence with the local Summary of Product Characteristics (SmPC) or Prescribing Information (PI).
Interventions
BIOLOGICALInjection Brolucizumab
Single-chain antibody fragment (scFv) Brolucizumab 6 mg was administered by Intravitreal (IVT) injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) were performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Female or male, treatment naïve patient with ≥50 years of age, with neovascular age-related macular degeneration (nAMD). * Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study. Note: In case where both eyes are affected, data of only one eye \['study eye'\] will be recorded. Selection of the eye to be considered for the purpose of the study \[referred to as 'study eye'\] will be as per the Investigator's discretion.
Exclusion criteria
* Patients fulfilling any of the following criteria are not eligible for this study: * Patient having other eye diseases that could compromise the VA. * Patient with existing or suspected ocular or periocular infection in the study eye. * Patient with an existing intraocular inflammation (IOI). * Patient with uncontrolled glaucoma defined as intraocular pressure \> 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment. * Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study. * Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug. |
| Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term | Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug. |
| Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab | Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug. |
| Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye | Week 56 | Characterize the number of anti-VEGF injections during the 56 weeks of treatment with brolucizumab. |
| Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab | Week 56 | Characterize number of non-injection visits during the 56 weeks of treatment with brolucizumab. |
| Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab. | Week 56 | Characterize the total number of visits during the 56 weeks of treatment with brolucizumab. |
| Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 Weeks. | Week 56 | — |
| Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks. | Week 56 | — |
| Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye | Baseline, Week 16, Week 56 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
| Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye | Week 16 and Week 56 | Estimate effect of brolucizumab on fluid (increased/reduced/unchanged) from baseline to week 16 and week 56 based on Optical Coherence Tomography (SD-OCT) Image Analysis from the central reading center. |
| Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye | Week 16 and Week 56 | Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56. Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
| Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye | Week 16 and Week 56 | Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56. Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
| Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye | Baseline, Week 16 and Week 56 | Estimate effect of brolucizumab on central subfield thickness (CST) from baseline to week 16 and week 56 as measured by Optical Coherence Tomography (in µm). |
| Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye | Baseline, Week 16 and Week 56 | Estimate effect of brolucizumab on central subfield thickness (CST) from baseline to week 16 and week 56 as measured by Optical Coherence Tomography (in µm). |
| Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye | Week 16 and Week 56 | Estimate effect of brolucizumab on fluid (increased/reduced/unchanged) from baseline to week 16 and week 56 based on Optical Coherence Tomography (SD-OCT) Image Analysis from the central reading center. |
| Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye | Baseline, Week 16, Week 56 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
| Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Baseline, Week 16 and Week 56 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
| Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Baseline, Week 16 and Week 56 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
Countries
India
Participant flow
Pre-assignment details
In case where both eyes were affected, data of only one eye \['study eye'\] was recorded. Selection of the eye to be considered for the purpose of the study \[referred to as 'study eye'\] was as per the Investigator's discretion.
Participants by arm
| Arm | Count |
|---|---|
| Brolucizumab Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Brolucizumab |
|---|---|
| Age, Continuous | 67.7 Years STANDARD_DEVIATION 9.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 105 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 105 |
| other Total, other adverse events | 67 / 105 |
| serious Total, serious adverse events | 0 / 105 |
Outcome results
Primary
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab | Ocular AEs | 3 Participants |
| Brolucizumab | Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab | TEAEs | 3 Participants |
| Brolucizumab | Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab | Systemic (non-ocular) AEs | 0 Participants |
| Brolucizumab | Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab | Suspected TEAEs related to the study medication | 3 Participants |
| Brolucizumab | Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab | Serious TEAEs | 0 Participants |
| Brolucizumab | Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab | TEAEs leading to death | 0 Participants |
| Brolucizumab | Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab | TEAEs leading to discontinuation of study | 2 Participants |
Primary
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Outcome of AEs - Recovered or resolved | 61 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Outcome of AEs - Recovering or resolving | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | At least one AE | 67 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | At least one Ocular AEs | 50 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | At least one Ocular AE in the Study eye | 45 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | At least one Ocular AE in the Fellow eye | 9 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Systemic (non-ocular) AEs | 31 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | TEAEs | 3 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | AEs related to brolucizumab | 3 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Ongoing AEs | 10 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | CTCAE grade of AEs - Total | 67 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | CTCAE grade of AEs - Mild | 63 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | CTCAE grade of AEs - Moderate | 6 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | CTCAE grade of AEs - Severe | 1 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | CTCAE grade of AEs - Life Threatening | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | CTCAE grade of AEs - Death Related to AE | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Serious adverse event | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Serious AEs related to brolucizumab | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | AEs Action Taken - Total | 67 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | AEs Action Taken - No action taken | 66 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | AEs Action Taken - Investigational treatment permanently discontinued due to this adverse event | 5 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Outcome of AEs - Total | 67 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Outcome of AEs - Not Recovered or Not Resolved | 10 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Outcome of AEs - Recovered or resolved with sequelae | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Outcome of AEs - Fatal | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Outcome of AEs - Unknown | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | AEs leading to discontinuation from the study | 4 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | AEs leading to death | 0 Participants |
| Brolucizumab | Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. | Related AEs leading to death | 0 Participants |
Primary
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Patients with at least one Ocular AEs | 50 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Total | 48 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Conjunctival hemorrhage | 13 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Cataract | 10 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Vision blurred | 9 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Ocular hyperemia | 7 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders -Lacrimation increased | 6 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Eye pain | 4 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Eye pruritus | 4 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Visual impairment | 3 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Macular scar | 2 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Retinal hemorrhage | 2 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders -Vitritis | 2 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Conjunctival hyperemia | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Eye irritation | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Retinal pigment epithelial tear | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Retinal vasculitis | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Swelling of eyelid | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders -Uveitis | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Eye disorders - Vitreous floaters | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Surgical and medical procedures - Cataract operation | 6 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | General disorders and administration site conditions - Total | 3 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | General disorders and administration site conditions -Injection site pain | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | General disorders and administration site conditions - Instillation site lacrimation | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | General disorders and administration site conditions -Sensation of foreign body | 1 Participants |
| Brolucizumab | Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab | Infections and infestations - Conjunctivitis | 1 Participants |
Primary
Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term | Patients with at least one TEAE | 3 Participants |
| Brolucizumab | Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term | Eye disorders - Total | 3 Participants |
| Brolucizumab | Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term | Eye disorders - Vitritis | 2 Participants |
| Brolucizumab | Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term | Eye disorders - Retinal vasculitis | 1 Participants |
| Brolucizumab | Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term | Eye disorders - Uveitis | 1 Participants |
Secondary
Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Baseline, Week 16, Week 56
Population: Full analysis set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment at the specified timeframe.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Brolucizumab | Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye | Week 16 | 7.0 Letters read |
| Brolucizumab | Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye | Week 56 | 15.0 Letters read |
Secondary
Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye
Estimate effect of brolucizumab on central subfield thickness (CST) from baseline to week 16 and week 56 as measured by Optical Coherence Tomography (in µm).
Time frame: Baseline, Week 16 and Week 56
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab | Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye | Week 16 | -106.9 μm | Standard Deviation 129.14 |
| Brolucizumab | Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye | Week 56 | -103.1 μm | Standard Deviation 152.64 |
Secondary
Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye
Estimate effect of brolucizumab on central subfield thickness (CST) from baseline to week 16 and week 56 as measured by Optical Coherence Tomography (in µm).
Time frame: Baseline, Week 16 and Week 56
Population: Full analysis set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Brolucizumab | Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye | Week 16 | -60.0 μm |
| Brolucizumab | Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye | Week 56 | -66.5 μm |
Secondary
Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Baseline, Week 16, Week 56
Population: Full analysis set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment at the specified timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab | Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye | Week 16 | 10.7 Letters read | Standard Deviation 12.53 |
| Brolucizumab | Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye | Week 56 | 15.3 Letters read | Standard Deviation 13.74 |
Secondary
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye
Estimate effect of brolucizumab on fluid (increased/reduced/unchanged) from baseline to week 16 and week 56 based on Optical Coherence Tomography (SD-OCT) Image Analysis from the central reading center.
Time frame: Week 16 and Week 56
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye | Week 16 Decreased | 0 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye | Week 16 Increased | 0 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye | Week 16 Absent | 2 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye | Week 56 Absent | 2 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye | Week 56 Decreased | 0 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye | Week 56 Increased | 0 Participants |
Secondary
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye
Estimate effect of brolucizumab on fluid (increased/reduced/unchanged) from baseline to week 16 and week 56 based on Optical Coherence Tomography (SD-OCT) Image Analysis from the central reading center.
Time frame: Week 16 and Week 56
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye | Week 16 Absent | 23 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye | Week 16 Decreased | 54 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye | Week 16 Increased | 22 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye | Week 56 Absent | 43 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye | Week 56 Decreased | 50 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye | Week 56 Increased | 7 Participants |
Secondary
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye
Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56. Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Time frame: Week 16 and Week 56
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye | Week 16 Absent | 10 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye | Week 16 Decreased | 0 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye | Week 16 Increased | 0 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye | Week 56 Absent | 11 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye | Week 56 Decreased | 0 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye | Week 56 Increased | 0 Participants |
Secondary
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye
Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56. Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Time frame: Week 16 and Week 56
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye | Week 16 Absent | 20 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye | Week 16 Decreased | 57 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye | Week 16 Increased | 14 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye | Week 56 Absent | 30 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye | Week 56 Decreased | 57 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye | Week 56 Increased | 4 Participants |
Secondary
Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks.
Time frame: Week 56
Population: Full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks. | At least one duration of interval between injections ≥ 12 weeks | 74 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks. | q8w dosing | 27 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks. | q12w dosing | 74 Participants |
Secondary
Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 Weeks.
Time frame: Week 56
Population: Full analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brolucizumab | Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 Weeks. | 27 Participants |
Secondary
Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Baseline, Week 16 and Week 56
Population: Full analysis set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment at the specified timeframe.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 16 - Total Visual Acuity Score (ETDRS letters) Gain ≥ 15 ETDRS letters | 27 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 16 -Total Visual Acuity Score (ETDRS letters) Gain ≥ 10 ETDRS letters | 41 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 16 -Total Visual Acuity Score (ETDRS letters) Gain ≥ 5 ETDRS letters | 79 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 56 - Total Visual Acuity Score (ETDRS letters) Gain ≥ 15 ETDRS letters | 46 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 56 - Total Visual Acuity Score (ETDRS letters) Gain ≥ 10 ETDRS letters | 62 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 56 - Total Visual Acuity Score (ETDRS letters) Gain ≥ 5 ETDRS letters | 78 Participants |
Secondary
Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Baseline, Week 16 and Week 56
Population: Full analysis set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment at the specified timeframe.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 16 - Total Visual Acuity Score (ETDRS letters) loss ≥ 15 ETDRS letters | 2 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 16 -Total Visual Acuity Score (ETDRS letters) loss ≥ 10 ETDRS letters | 2 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 16 -Total Visual Acuity Score (ETDRS letters) loss ≥ 5 ETDRS letters | 3 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 56 - Total Visual Acuity Score (ETDRS letters) loss ≥ 15 ETDRS letters | 2 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 56 - Total Visual Acuity Score (ETDRS letters) loss ≥ 10 ETDRS letters | 2 Participants |
| Brolucizumab | Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye | Week 56 - Total Visual Acuity Score (ETDRS letters) loss ≥ 5 ETDRS letters | 3 Participants |
Secondary
Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye
Characterize the number of anti-VEGF injections during the 56 weeks of treatment with brolucizumab.
Time frame: Week 56
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab | Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye | 6.2 Injections | Standard Deviation 1.3 |
Secondary
Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab
Characterize number of non-injection visits during the 56 weeks of treatment with brolucizumab.
Time frame: Week 56
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab | Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab | 0.2 Visits | Standard Deviation 0.71 |
Secondary
Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab.
Characterize the total number of visits during the 56 weeks of treatment with brolucizumab.
Time frame: Week 56
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab | Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab. | 6.2 visits | Standard Deviation 1.3 |