| 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. | | Posted | | Count of Participants | | Participants | | 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. | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| At least one AE | | | | At least one Ocular AEs | | | | At least one Ocular AE in the Study eye | | |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Letters read | | Baseline, Week 16, Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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. | Posted | | Median | Inter-Quartile Range | Letters read | | Baseline, Week 16, Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 16 and Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 16 and Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | Injections | | Week 56 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | Visits | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | visits | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 Weeks. | | | Posted | | Count of Participants | | Participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks. | | | Posted | | Count of Participants | | Participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | Week 16 and Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | Week 16 and Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | Week 16 and Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | Week 16 and Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | | Posted | | Mean | Standard Deviation | μm | | Baseline, Week 16 and Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | | Posted | | Median | Inter-Quartile Range | μm | | Baseline, Week 16 and Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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