| Primary | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00010.6(9.3 to 11.9)
- OG0019.4(8.1 to 10.7)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | | <0.001 | | LS mean difference | 1.2 | Standard Error of the Mean | 0.94 | 2-Sided | 95 | -0.6 | 3.1 | | | | | Non-Inferiority | (4-letter margin) (1-sided) | |
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| Secondary | Average Mean Change From Baseline in BCVA Over the Period Week 40 Through Week 52 for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the period Week 40 through Week 52. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Baseline, period Week 40 through Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
|
| Secondary | (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 and up to q12w/q16w up to Week 100. | The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen [every 12 weeks (q12w)]. | Full Analysis Set - Efficacy/Safety approach | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 52, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 Within Those Patients That Qualified for q12w at Week 36 | The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen [every 12 weeks (q12w)]. | Full Analysis Set - Efficacy/Safety approach | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 36, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w/q16w up to Week 100, Within Those Patients That Qualified for q12w at Week 36 | Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen [every 12 weeks (q12w)]. | Full Analysis Set - Efficacy/Safety approach | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 36, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained on q16w up to Week 100 Within the Patients on q12w at Week 68 and on q16w at Week 76 | Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen [every 12 weeks (q12w)]. | Full Analysis Set - Efficacy/Safety approach | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 68, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | (Brolucizumab Treatment Arm Only): Percentage of Participants Re-assigned and Maintained on q12w up to Week 100 Within the Patients on q8w at Week 68 and on q12w at Week 80 | Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen [every 12 weeks (q12w)]. | Full Analysis Set - Efficacy/Safety approach | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 68, Week 80, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | (Brolucizumab Treatment Arm Only): Number of Participants With Injections Per Planned Dosing Regimen (Every 8, 12 or 16 Weeks) | Reported categorically for the subjects who completed the study treatment period: every 8 weeks (q8w), Every 12 weeks (q12w), Every 16 weeks (q16w) | Full Analysis Set. Only participants who completed the study treatment period were included in the analysis. | Posted | | Count of Participants | | Participants | | Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
|
| Secondary | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 4 to Week 52/100 for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the periods: Week 4 through Week 52, Week 4 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Baseline, period Week 4 through Week 52, period Week 4 through Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
|
| Secondary | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 20 to Week 52/100 and Week 28 to Week 52/100 for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the periods: Week 20 through Week 52, Week 20 through Week 100, Week 28 through Week 52, Week 28 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Baseline, period Week 20 through Week 52, period Week 20 through Week 100, period Week 28 through Week 52, period Week 28 through Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 |
|
| Secondary | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 88 to 100 for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the period Week 88 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Baseline, period Week 88 through Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
|
| Secondary | Percentage of Participants Who Gained >= 5 Letters in BCVA From Baseline or Reached BCVA >= 84 Letters at Each Post-baseline Visit for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | |
|
| Secondary | Percentage of Participants Who Gained >= 10 Letters in BCVA From Baseline or Reached BCVA >= 84 Letters at Each Post-baseline Visit for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | |
|
| Secondary | Percentage of Participants Who Gained >= 15 Letters in BCVA From Baseline or Reached BCVA >= 84 Letters at Each Post-baseline Visit for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | |
|
| Secondary | Percentage of Participants Who Lost >= 5 ETDRS Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Each Post-baseline Visit for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | |
|
| Secondary | Percentage of Participants Who Lost >= 10 ETDRS Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Each Post-baseline Visit for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | |
|
| Secondary | Percentage of Participants Who Lost >= 15 ETDRS Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Each Post-baseline Visit for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | |
|
| Secondary | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | |
|
| Secondary | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Mean | Standard Deviation | Micrometers | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Average Mean Change From Baseline in Central Subfield Thickness (CSFT) Over the Period Week 40 Through Week 52 / Week 88 Through Week 100 for the Study Eye | The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. For each participants, this endpoint was derived as the average of the changes from Baseline to Weeks 40, 44, 48, 52. Then the same was derived over the period Week 88 through Week 100, considering the average of the changes from Baseline to Weeks 88, 92, 96, 100. This endpoint was only assessed in the year-2 analysis (Week 100). | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Least Squares Mean | 95% Confidence Interval | Micrometers | | Baseline, period Week 40 through Week 52, period Week 88 through Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
|
| Secondary | Average Mean Change From Baseline in CSFT Over the Period Week 4 to Week 52 / 100 for the Study Eye | The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Least Squares Mean | 95% Confidence Interval | Micrometers | | Baseline, period Week 4 through Week 52, period Week 4 through Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Presence of Subretinal Fluid (SRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Subretinal fluid status assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Presence of Intraretinal Fluid (IRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Intraretinal fluid status assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Fluid status (SRF and/or IRF) assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Participants With Presence of Leakage on Fluorescein Angiography (FA) at Weeks 52 and 100 | Presence of leakage on Fluorescein Angiography as assessed by fluorescein angiography. Leakage on FA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Percentage of Participants With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS-DRSS Score of at Least 61 by Week 100 | The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | The number of participants with ocular and non-ocular adverse events was was assessed by CTCAE and reported categorically: Mild, Moderate, Severe. | | Posted | | Count of Participants | | Participants | | From randomization till 30 days safety follow-up, assessed up to 35 months. | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome. | Full Analysis Set - Observed. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and were not included in this analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Week 28, Week 52, Week 76, Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Systemic Brolucizumab Concentration | Serum samples were taken approximately 24 hours after the first dose and 24 hours after the treatment at Week 24 to confirm the systemic brolucizumab exposure in patients with visual impairment due to diabetic macular edema. | Safety Set. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and not included in the analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm | Integrated ADA Status was categorized: ADA negative or ADA positive with no boost, Induced or Boosted, Missing ADA at pre-dose or no post-dose ADA data.
- ADA negative: (a) ADA negative at all time points (pre-dose and post-dose), (b) ADA negative at pre-dose and no titer values above 40 at all other time points, (c) ADA titer of 40 at pre-dose but negative at all other time points.
- ADA positive with no boost: ADA positive at pre-dose, post-dose titer values do not increase from pre-dose by more than 3-fold (1 dilution) at any time point.
- Induced: ADA negative at pre-dose, post-dose titer value of 120 or more at any time point.
- Boosted: ADA positive at pre-dose, post-dose titer values increase from pre-dose by more than 3-fold (1 dilution) at any time point.
| Safety Set. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and not included in the analysis. | Posted | | Count of Participants | | Participants | | Up to Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm - Adjusted for Pre-existing ADA Status | Integrated ADA Status - adjusted for pre-existing ADA status was categorized: ADA negative, ADA positive with no boost, Induced, Boosted.
- ADA negative: (a) ADA negative at all time points (pre-dose and post-dose), (b) ADA negative at pre-dose and no titer values above 40 at all other time points, (c) ADA titer of 40 at pre-dose but negative at all other time points.
- ADA positive with no boost: ADA positive at pre-dose, post-dose titer values do not increase from pre-dose by more than 3-fold (1 dilution) at any time point.
- Induced: ADA negative at pre-dose, post-dose titer value of 120 or more at any time point.
- Boosted: ADA positive at pre-dose, post-dose titer values increase from pre-dose by more than 3-fold (1 dilution) at any time point.
| Safety Set. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and not included in the analysis. | Posted | | Count of Participants | | Participants | | Up to Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Pre-existing ADA Status and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye | Pre-existing ADA status and incidence of Adverse Event of Special Interest (AESI) in the study eye was categorized: Negative, Positive. | Safety Set. AEs started after the subject discontinued study treatment and started alternative diabetic macular edema (DME) treatment in the study eye were censored and not included in the analysis. | Posted | | Count of Participants | | Participants | | Up to Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| |
| Secondary | Integrated ADA Status up to Week 100 and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye. | Integrated ADA status up to Week 100 and incidence of Adverse Event of Special Interest (AESI) in the study eye was categorized: ADA-negative or no boost, Induced or boosted. | Safety Set. AEs started after the subject discontinued study treatment and started alternative diabetic macular edema (DME) treatment in the study eye were censored and not included in the analysis. | Posted | | Count of Participants | | Participants | | Up to Week 100 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | | OG001 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
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