Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, intravitreal injection, brolucizumab, aflibercept, double-masked
Brief summary
This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with visual impairment due to diabetic macular edema (DME).
Detailed description
The study included a screening period of up to 2 weeks to assess eligibility, followed by a double-masked treatment period (Day 1 to Week 96). The baseline visit was defined as Day 1/Visit 1, and end of treatment visit as Visit 27 (Week 96). After the last treatment visit, there was a post-treatment follow-up period from Week 96 to Week 100 and an exit visit at Week 100. Subjects were assigned to one of two treatment arms in a 1:1 ratio: brolucizumab 6 mg/0.05 mL (5 loading doses each administered every 6 weeks (q6w) during loading phase then q12w/q8w during maintenance phase with an option to extend treatment interval by 4 weeks during the second year) or aflibercept 2 mg/0.05 mL (5 loading doses each administered every 4 weeks (q4w) during loading phase then q8w during maintenance phase). Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Week 32 and Week 36, i.e., 8 and 12 weeks after the end of the loading phase for subjects receiving brolucizumab, and at Week 48, Week 60 and Week 72 (i.e., every 12 weeks). In the brolucizumab arm, subjects who qualified for q12w during this initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at any of the subsequent DAA visits, in which case subjects were switched to a q8w treatment interval until Week 72. A one-time disease stability assessment was performed by the masked investigator at Week 72 in both treatment arms with the purpose of evaluating the potential for treatment interval extension by 4 weeks. The subjects in the brolucizumab arm who demonstrated disease stability in the one-time assessment at Week 72 under their current assigned treatment regimen (q12w or q8w) were considered for treatment interval extension. To evaluate the adequacy of the individualized q8w, q12w or q16w treatment intervals in the brolucizumab arm, DAAs were performed at every visit from Week 72 up to and including Week 96 (i.e., every 4 weeks) and subjects had their treatment interval modified accordingly. If after Week 72 disease activity had been identified by the masked investigator at a scheduled treatment visit (according to the subject specific treatment schedule q12w or q16w) the subject was assigned to q8w treatment schedule.
Interventions
DRUGBrolucizumab
Intravitreal injection
DRUGAflibercept
Intravitreal injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: General * Patients must give written informed consent before any study related assessments are performed * Patients with type 1 or type 2 diabetes mellitus and HbA1c of =\< 10% at screening * Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study Study Eye * Visual impairment due to DME with: 1. BCVA score between 78 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320), at screening and baseline 2. DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of \>= 320 micrometers (μm) on SD-OCT at screening If both eyes are eligible, the eye with the worse visual acuity will be selected for study eye. However, the investigator may select the eye with better visual acuity, based on medical reasons or local ethical requirements. Key
Exclusion criteria
* Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye * Active proliferative diabetic retinopathy in the study eye as per the investigator * Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause) * Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline * Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques * Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg) on medication or according to investigator's judgment, at screening or baseline * Neovascularization of the iris in the study eye at screening or baseline * Evidence of vitreomacular traction in the study eye at screening or baseline which, in the opinion of the investigator, affect visual acuity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 for the Study Eye | Baseline, Week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 and up to q12w/q16w up to Week 100. | Week 52, 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 \[every 12 weeks (q12w)\]. |
| (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 Within Those Patients That Qualified for q12w at Week 36 | Week 36, Week 52 | 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 \[every 12 weeks (q12w)\]. |
| (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 | Week 36, Week 100 | 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 \[every 12 weeks (q12w)\]. |
| (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 | Week 68, Week 76, Week 100 | 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 \[every 12 weeks (q12w)\]. |
| (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 | Week 68, Week 80, Week 100 | 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 \[every 12 weeks (q12w)\]. |
| (Brolucizumab Treatment Arm Only): Number of Participants With Injections Per Planned Dosing Regimen (Every 8, 12 or 16 Weeks) | Week 100 | Reported categorically for the subjects who completed the study treatment period: every 8 weeks (q8w), Every 12 weeks (q12w), Every 16 weeks (q16w) |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | 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 | 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. |
| Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 4 to Week 52/100 for the Study Eye | Baseline, period Week 4 through Week 52, period Week 4 through Week 100 | 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. |
| 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 | 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 | 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. |
| Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 88 to 100 for the Study Eye | Baseline, period Week 88 through Week 100 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | 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 | 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. |
| Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | 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 | 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. |
| 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 | Baseline, period Week 40 through Week 52, period Week 88 through Week 100 | 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). |
| Average Mean Change From Baseline in CSFT Over the Period Week 4 to Week 52 / 100 for the Study Eye | Baseline, period Week 4 through Week 52, period Week 4 through Week 100 | 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. |
| Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | 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 | 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. |
| Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | 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 | 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. |
| Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | 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 | 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. |
| Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | 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 | 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. |
| Percentage of Participants With Presence of Leakage on Fluorescein Angiography (FA) at Weeks 52 and 100 | Week 52, Week 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. |
| Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Baseline, Week 28, Week 52, Week 76, 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. |
| Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Baseline, Week 28, Week 52, Week 76, 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. |
| Percentage of Participants With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS-DRSS Score of at Least 61 by Week 100 | 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. |
| Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | From randomization till 30 days safety follow-up, assessed up to 35 months. | The number of participants with ocular and non-ocular adverse events was was assessed by CTCAE and reported categorically: Mild, Moderate, Severe. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
| Average Mean Change From Baseline in BCVA Over the Period Week 40 Through Week 52 for the Study Eye | Baseline, period Week 40 through Week 52 | 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. |
| Systemic Brolucizumab Concentration | Up to Week 24 | 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. |
| Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm | Up to Week 100 | 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. |
| Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm - Adjusted for Pre-existing ADA Status | Up to Week 100 | 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. |
| Pre-existing ADA Status and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye | Up to Week 100 | Pre-existing ADA status and incidence of Adverse Event of Special Interest (AESI) in the study eye was categorized: Negative, Positive. |
| Integrated ADA Status up to Week 100 and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye. | Up to Week 100 | 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. |
| Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Baseline, Week 28, Week 52, Week 76, Week 100 | 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. |
Countries
Belgium, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Hungary, India, Latvia, Lebanon, Lithuania, Malaysia, Norway, Poland, Russia, Singapore, Slovakia, South Korea, Sweden, Switzerland, Taiwan, Turkey (Türkiye)
Participant flow
Recruitment details
This study was conducted in 79 centers in 23 countries: Belgium (1), Bulgaria (3), Czech Republic (3), Denmark (2), Estonia (2), France (12), Germany (7), Hungary (5), India (5), Republic of Korea (6), Latvia (1), Lebanon (3), Lithuania (2), Malaysia (2), Norway (1), Poland (1), Russia (5), Singapore (2), Slovakia (5), Sweden (1), Switzerland (2), Taiwan (3), Turkey (5).
Participants by arm
| Arm | Count |
|---|---|
| Brolucizumab 6 mg Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | 179 |
| Aflibercept 2 mg Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks | 181 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 |
| Overall Study | Death | 13 | 9 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Physician Decision | 2 | 3 |
| Overall Study | Withdrawal by Subject | 14 | 7 |
Baseline characteristics
| Characteristic | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| Age, Continuous | 62.3 Years STANDARD_DEVIATION 10.55 | 62.2 Years STANDARD_DEVIATION 9.48 | 62.2 Years STANDARD_DEVIATION 10.01 |
| Age, Customized < 65 years | 100 Participants | 102 Participants | 202 Participants |
| Age, Customized >= 65 years | 79 Participants | 79 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants | 170 Participants | 333 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 7 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 43 Participants | 48 Participants | 91 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 133 Participants | 132 Participants | 265 Participants |
| Sex: Female, Male Female | 59 Participants | 66 Participants | 125 Participants |
| Sex: Female, Male Male | 120 Participants | 115 Participants | 235 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 13 / 179 | 9 / 181 | 22 / 360 |
| other Total, other adverse events | 131 / 179 | 134 / 181 | 265 / 360 |
| serious Total, serious adverse events | 53 / 179 | 60 / 181 | 113 / 360 |
Outcome results
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.
Time frame: Baseline, Week 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Brolucizumab 6 mg | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 for the Study Eye | 10.6 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 for the Study Eye | 9.4 Scores on a scale |
Comparison: BCVA at Week 52p-value: <0.00195% CI: [-0.6, 3.1]ANOVA
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.
Time frame: Baseline, period Week 40 through Week 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Brolucizumab 6 mg | Average Mean Change From Baseline in BCVA Over the Period Week 40 Through Week 52 for the Study Eye | 10.3 Scores on a scale |
| Aflibercept 2 mg | Average Mean Change From Baseline in BCVA Over the Period Week 40 Through Week 52 for the Study Eye | 9.4 Scores on a scale |
Comparison: BCVA over period Week 40 through Week 52p-value: <0.00195% CI: [-0.9, 2.6]ANOVA
Comparison: BCVA over period Week 40 through Week 52p-value: 0.164ANOVA
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Brolucizumab 6 mg | 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 | period Week 20 through Week 52 | 10.1 Scores on a scale |
| Brolucizumab 6 mg | 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 | period Week 20 through Week 100 | 10.4 Scores on a scale |
| Brolucizumab 6 mg | 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 | period Week 28 through Week 52 | 10.1 Scores on a scale |
| Brolucizumab 6 mg | 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 | period Week 28 through Week 100 | 10.5 Scores on a scale |
| Aflibercept 2 mg | 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 | period Week 28 through Week 100 | 9.2 Scores on a scale |
| Aflibercept 2 mg | 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 | period Week 20 through Week 52 | 9.3 Scores on a scale |
| Aflibercept 2 mg | 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 | period Week 28 through Week 52 | 9.4 Scores on a scale |
| Aflibercept 2 mg | 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 | period Week 20 through Week 100 | 9.2 Scores on a scale |
Comparison: BCVA over period Week 20 through Week 5295% CI: [-0.9, 2.4]
Comparison: BCVA over period Week 28 through Week 5295% CI: [-0.9, 2.5]
Comparison: BCVA over period Week 20 through Week 10095% CI: [-0.5, 2.9]
Comparison: BCVA over period Week 28 through Week 10095% CI: [-0.5, 3]
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.
Time frame: Baseline, period Week 4 through Week 52, period Week 4 through Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Brolucizumab 6 mg | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 4 to Week 52/100 for the Study Eye | period Week 4 through Week 52 | 9.1 Scores on a scale |
| Brolucizumab 6 mg | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 4 to Week 52/100 for the Study Eye | period Week 4 through Week 100 | 9.8 Scores on a scale |
| Aflibercept 2 mg | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 4 to Week 52/100 for the Study Eye | period Week 4 through Week 52 | 8.4 Scores on a scale |
| Aflibercept 2 mg | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 4 to Week 52/100 for the Study Eye | period Week 4 through Week 100 | 8.7 Scores on a scale |
Comparison: BCVA over period Week 4 through Week 5295% CI: [-0.6, 2.1]
Comparison: BCVA over period Week 4 through Week 10095% CI: [-0.4, 2.6]
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.
Time frame: Baseline, period Week 88 through Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Brolucizumab 6 mg | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 88 to 100 for the Study Eye | 10.8 Scores on a scale |
| Aflibercept 2 mg | Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 88 to 100 for the Study Eye | 8.7 Scores on a scale |
Comparison: BCVA over period Week 88 through Week 10095% CI: [-0.1, 4.3]
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).
Time frame: Baseline, period Week 40 through Week 52, period Week 88 through Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Brolucizumab 6 mg | 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 | period Week 40 through Week 52 | -187.1 Micrometers |
| Brolucizumab 6 mg | 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 | period Week 88 through Week 100 | -196.6 Micrometers |
| Aflibercept 2 mg | 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 | period Week 40 through Week 52 | -157.7 Micrometers |
| Aflibercept 2 mg | 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 | period Week 88 through Week 100 | -173.4 Micrometers |
Comparison: CSFT over period Week 40 through Week 52p-value: <0.00395% CI: [-48.6, -10.2]ANOVA
Comparison: CSFT over period Week 40 through Week 52p-value: 0.001ANOVA
Comparison: CSFT over period Week 88 through Week 10095% CI: [-43.5, -3]
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.
Time frame: Baseline, period Week 4 through Week 52, period Week 4 through Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Brolucizumab 6 mg | Average Mean Change From Baseline in CSFT Over the Period Week 4 to Week 52 / 100 for the Study Eye | period Week 4 through Week 52 | -172.8 Micrometers |
| Brolucizumab 6 mg | Average Mean Change From Baseline in CSFT Over the Period Week 4 to Week 52 / 100 for the Study Eye | period Week 4 through Week 100 | -181.8 Micrometers |
| Aflibercept 2 mg | Average Mean Change From Baseline in CSFT Over the Period Week 4 to Week 52 / 100 for the Study Eye | period Week 4 through Week 52 | -145.4 Micrometers |
| Aflibercept 2 mg | Average Mean Change From Baseline in CSFT Over the Period Week 4 to Week 52 / 100 for the Study Eye | period Week 4 through Week 100 | -156.1 Micrometers |
Comparison: CSFT over period Week 4 through Week 5295% CI: [-45.8, -9]
Comparison: CSFT over period Week 4 through Week 10095% CI: [-44, -7.5]
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)
Time frame: Week 100
Population: Full Analysis Set. Only participants who completed the study treatment period were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | (Brolucizumab Treatment Arm Only): Number of Participants With Injections Per Planned Dosing Regimen (Every 8, 12 or 16 Weeks) | q8w | 74 Participants |
| Brolucizumab 6 mg | (Brolucizumab Treatment Arm Only): Number of Participants With Injections Per Planned Dosing Regimen (Every 8, 12 or 16 Weeks) | q12w | 32 Participants |
| Brolucizumab 6 mg | (Brolucizumab Treatment Arm Only): Number of Participants With Injections Per Planned Dosing Regimen (Every 8, 12 or 16 Weeks) | q16w | 35 Participants |
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 \[every 12 weeks (q12w)\].
Time frame: Week 36, Week 100
Population: Full Analysis Set - Efficacy/Safety approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | (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 | 69.6 Percentage of participants |
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 \[every 12 weeks (q12w)\].
Time frame: Week 52, Week 100
Population: Full Analysis Set - Efficacy/Safety approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 and up to q12w/q16w up to Week 100. | Week 48 | 50.3 Percentage of participants |
| Brolucizumab 6 mg | (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 and up to q12w/q16w up to Week 100. | Week 96 | 36.8 Percentage of participants |
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 \[every 12 weeks (q12w)\].
Time frame: Week 36, Week 52
Population: Full Analysis Set - Efficacy/Safety approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 Within Those Patients That Qualified for q12w at Week 36 | 95.1 Percentage of participants |
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 \[every 12 weeks (q12w)\].
Time frame: Week 68, Week 76, Week 100
Population: Full Analysis Set - Efficacy/Safety approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | (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 | 87.9 Percentage of participants |
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 \[every 12 weeks (q12w)\].
Time frame: Week 68, Week 80, Week 100
Population: Full Analysis Set - Efficacy/Safety approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | (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 | 73.1 Percentage of participants |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Week 28 | 5.7 Score on a scale | Standard Deviation 11.91 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Week 52 | 8.9 Score on a scale | Standard Deviation 11.67 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Week 76 | 9.8 Score on a scale | Standard Deviation 12.22 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Week 100 | 9.0 Score on a scale | Standard Deviation 12.94 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Week 100 | 6.2 Score on a scale | Standard Deviation 14.13 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Week 28 | 6.3 Score on a scale | Standard Deviation 10.19 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Week 76 | 7.6 Score on a scale | Standard Deviation 11.81 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score | Week 52 | 6.7 Score on a scale | Standard Deviation 12.12 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Week 28 | 3.9 Score on a scale | Standard Deviation 18.66 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Week 52 | 5.8 Score on a scale | Standard Deviation 22.34 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Week 76 | 8.9 Score on a scale | Standard Deviation 21.21 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Week 100 | 6.7 Score on a scale | Standard Deviation 19.14 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Week 100 | 5.7 Score on a scale | Standard Deviation 21.8 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Week 28 | 4.3 Score on a scale | Standard Deviation 19.92 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Week 76 | 7.1 Score on a scale | Standard Deviation 22.57 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating | Week 52 | 4.8 Score on a scale | Standard Deviation 23.12 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Week 28 | 3.5 Score on a scale | Standard Deviation 15.1 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Week 52 | 5.8 Score on a scale | Standard Deviation 15.08 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Week 76 | 5.2 Score on a scale | Standard Deviation 15.73 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Week 100 | 4.3 Score on a scale | Standard Deviation 14.7 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Week 100 | 3.2 Score on a scale | Standard Deviation 15.48 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Week 28 | 4.2 Score on a scale | Standard Deviation 12.5 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Week 76 | 3.9 Score on a scale | Standard Deviation 13.79 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision | Week 52 | 3.6 Score on a scale | Standard Deviation 13.09 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Week 28 | 5.5 Score on a scale | Standard Deviation 19.39 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Week 52 | 7.6 Score on a scale | Standard Deviation 19.53 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Week 76 | 7.3 Score on a scale | Standard Deviation 20.19 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Week 100 | 6.8 Score on a scale | Standard Deviation 19.85 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Week 100 | 2.9 Score on a scale | Standard Deviation 24.79 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Week 28 | 3.6 Score on a scale | Standard Deviation 20.34 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Week 76 | 5.6 Score on a scale | Standard Deviation 23.24 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency | Week 52 | 3.9 Score on a scale | Standard Deviation 22.49 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Week 28 | 6.2 Score on a scale | Standard Deviation 18.87 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Week 52 | 11.7 Score on a scale | Standard Deviation 17.62 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Week 76 | 12.1 Score on a scale | Standard Deviation 18.32 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Week 100 | 11.4 Score on a scale | Standard Deviation 18.94 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Week 100 | 6.6 Score on a scale | Standard Deviation 19.07 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Week 28 | 5.6 Score on a scale | Standard Deviation 15.78 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Week 76 | 8.1 Score on a scale | Standard Deviation 16.71 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities | Week 52 | 8.2 Score on a scale | Standard Deviation 17.12 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Week 28 | 1.4 Score on a scale | Standard Deviation 18.75 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Week 52 | 6.4 Score on a scale | Standard Deviation 14.63 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Week 76 | 8.9 Score on a scale | Standard Deviation 15.95 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Week 100 | 5.4 Score on a scale | Standard Deviation 15.81 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Week 100 | 1.2 Score on a scale | Standard Deviation 16.75 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Week 28 | 4.8 Score on a scale | Standard Deviation 12.24 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Week 76 | 2.8 Score on a scale | Standard Deviation 15.88 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving | Week 52 | 4.2 Score on a scale | Standard Deviation 12.81 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Week 28 | 9.0 Score on a scale | Standard Deviation 16.11 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Week 52 | 11.2 Score on a scale | Standard Deviation 17.05 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Week 76 | 12.4 Score on a scale | Standard Deviation 16.49 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Week 100 | 12.0 Score on a scale | Standard Deviation 16.25 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Week 100 | 10.1 Score on a scale | Standard Deviation 18.73 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Week 28 | 10.2 Score on a scale | Standard Deviation 15.63 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Week 76 | 12.0 Score on a scale | Standard Deviation 16.4 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision | Week 52 | 10.5 Score on a scale | Standard Deviation 17.14 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Week 28 | 7.9 Score on a scale | Standard Deviation 19.53 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Week 52 | 12.6 Score on a scale | Standard Deviation 22.42 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Week 76 | 13.5 Score on a scale | Standard Deviation 21.02 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Week 100 | 13.3 Score on a scale | Standard Deviation 20.91 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Week 100 | 11.6 Score on a scale | Standard Deviation 26.31 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Week 28 | 10.1 Score on a scale | Standard Deviation 19.9 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Week 76 | 13.1 Score on a scale | Standard Deviation 23.1 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health | Week 52 | 10.1 Score on a scale | Standard Deviation 22.78 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Week 28 | 6.4 Score on a scale | Standard Deviation 20.83 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Week 52 | 10.5 Score on a scale | Standard Deviation 20.3 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Week 76 | 11.0 Score on a scale | Standard Deviation 21.91 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Week 100 | 13.0 Score on a scale | Standard Deviation 20.21 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Week 100 | 7.3 Score on a scale | Standard Deviation 21.71 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Week 28 | 6.3 Score on a scale | Standard Deviation 18.42 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Week 76 | 9.2 Score on a scale | Standard Deviation 18.76 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities | Week 52 | 9.3 Score on a scale | Standard Deviation 19.57 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Week 28 | 4.1 Score on a scale | Standard Deviation 19.52 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Week 52 | 4.6 Score on a scale | Standard Deviation 18.75 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Week 76 | 6.2 Score on a scale | Standard Deviation 16.95 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Week 100 | 4.3 Score on a scale | Standard Deviation 16.6 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Week 100 | 5.4 Score on a scale | Standard Deviation 20.77 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Week 28 | 4.6 Score on a scale | Standard Deviation 18.48 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Week 76 | 4.6 Score on a scale | Standard Deviation 18.68 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain | Week 52 | 4.4 Score on a scale | Standard Deviation 17.92 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Week 28 | 5.3 Score on a scale | Standard Deviation 18.83 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Week 52 | 7.2 Score on a scale | Standard Deviation 18.68 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Week 76 | 9.3 Score on a scale | Standard Deviation 19.64 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Week 100 | 8.5 Score on a scale | Standard Deviation 19.33 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Week 100 | 2.3 Score on a scale | Standard Deviation 19.37 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Week 28 | 4.0 Score on a scale | Standard Deviation 16.99 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Week 76 | 4.3 Score on a scale | Standard Deviation 17.82 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision | Week 52 | 3.2 Score on a scale | Standard Deviation 19.77 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Week 28 | 6.9 Score on a scale | Standard Deviation 25.13 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Week 52 | 12.2 Score on a scale | Standard Deviation 24.76 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Week 76 | 14.0 Score on a scale | Standard Deviation 28.44 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Week 100 | 12.3 Score on a scale | Standard Deviation 28.14 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Week 100 | 10.2 Score on a scale | Standard Deviation 27.12 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Week 28 | 9.4 Score on a scale | Standard Deviation 23.41 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Week 76 | 11.4 Score on a scale | Standard Deviation 27.83 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties | Week 52 | 8.7 Score on a scale | Standard Deviation 27.21 |
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Week 28 | 3.3 Score on a scale | Standard Deviation 15.82 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Week 52 | 7.1 Score on a scale | Standard Deviation 16.22 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Week 76 | 6.3 Score on a scale | Standard Deviation 16.65 |
| Brolucizumab 6 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Week 100 | 6.1 Score on a scale | Standard Deviation 16.78 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Week 100 | 4.1 Score on a scale | Standard Deviation 17.55 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Week 28 | 4.4 Score on a scale | Standard Deviation 16.48 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Week 76 | 5.0 Score on a scale | Standard Deviation 15.34 |
| Aflibercept 2 mg | Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning | Week 52 | 4.9 Score on a scale | Standard Deviation 15.59 |
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.
Time frame: Up to Week 100
Population: Safety Set. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm | ADA negative or ADA positive with no boost | 146 Participants |
| Brolucizumab 6 mg | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm | Induced or Boosted | 27 Participants |
| Brolucizumab 6 mg | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm | Missing ADA at pre-dose or no post-dose ADA data | 6 Participants |
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.
Time frame: Up to Week 100
Population: Safety Set. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm - Adjusted for Pre-existing ADA Status | ADA negative/ADA Negative or titer value of 40 at pre-dose | 53 Participants |
| Brolucizumab 6 mg | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm - Adjusted for Pre-existing ADA Status | ADA positive with no boost/ADA Positive at pre-dose | 93 Participants |
| Brolucizumab 6 mg | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm - Adjusted for Pre-existing ADA Status | Induced/ADA Negative at pre-dose | 14 Participants |
| Brolucizumab 6 mg | Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm - Adjusted for Pre-existing ADA Status | Boosted/ADA Positive at pre-dose | 13 Participants |
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.
Time frame: Up to Week 100
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Brolucizumab 6 mg | Integrated ADA Status up to Week 100 and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye. | Induced or boosted | No AESI | 25 Participants |
| Brolucizumab 6 mg | Integrated ADA Status up to Week 100 and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye. | ADA-negative or no boost | At least 1 AESI | 4 Participants |
| Brolucizumab 6 mg | Integrated ADA Status up to Week 100 and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye. | ADA-negative or no boost | No AESI | 142 Participants |
| Brolucizumab 6 mg | Integrated ADA Status up to Week 100 and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye. | Induced or boosted | At least 1 AESI | 2 Participants |
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 24 | 10.0 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 52 | 10.6 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 16 | 9.0 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 56 | 10.7 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 28 | 9.8 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 60 | 10.5 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 6 | 6.8 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 64 | 11.0 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 32 | 10.3 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 68 | 11.0 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 18 | 9.2 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 72 | 11.0 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 36 | 9.6 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 76 | 10.5 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 12 | 8.6 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 80 | 10.2 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 40 | 9.9 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 84 | 10.9 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 20 | 9.6 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 88 | 10.7 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 44 | 10.6 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 92 | 10.7 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 8 | 7.8 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 96 | 10.7 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 48 | 10.1 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 100 | 10.9 Scores on a scale |
| Brolucizumab 6 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 4 | 5.1 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 100 | 8.4 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 4 | 4.2 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 6 | 5.9 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 8 | 6.7 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 12 | 7.7 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 16 | 8.3 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 18 | 9.2 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 20 | 9.4 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 24 | 8.7 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 28 | 9.4 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 32 | 8.9 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 36 | 9.4 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 40 | 9.2 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 44 | 9.5 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 48 | 9.6 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 52 | 9.4 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 56 | 9.5 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 60 | 9.3 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 64 | 9.5 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 68 | 9.5 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 72 | 9.4 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 76 | 9.8 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 80 | 9.4 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 84 | 8.9 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 88 | 8.6 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 92 | 9.3 Scores on a scale |
| Aflibercept 2 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye | Week 96 | 8.5 Scores on a scale |
Comparison: BCVA at Week 5295% CI: [-0.6, 3.1]
Comparison: BCVA at Week 10095% CI: [0.2, 4.9]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 24 | -183.3 Micrometers | Standard Deviation 143.14 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 52 | -196.5 Micrometers | Standard Deviation 144.44 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 16 | -179.1 Micrometers | Standard Deviation 137.26 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 56 | -191.08 Micrometers | Standard Deviation 148.02 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 28 | -192.0 Micrometers | Standard Deviation 145.85 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 60 | -189.8 Micrometers | Standard Deviation 147.93 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 6 | -136.9 Micrometers | Standard Deviation 135.57 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 64 | -193.2 Micrometers | Standard Deviation 143.36 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 32 | -178.6 Micrometers | Standard Deviation 138.5 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 68 | -194.5 Micrometers | Standard Deviation 141.47 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 18 | -175.8 Micrometers | Standard Deviation 139.1 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 72 | -190.4 Micrometers | Standard Deviation 142.25 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 36 | -163.5 Micrometers | Standard Deviation 144.34 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 76 | -185.6 Micrometers | Standard Deviation 143.68 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 12 | -160.8 Micrometers | Standard Deviation 137.23 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 80 | -185.7 Micrometers | Standard Deviation 145.52 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 40 | -183.3 Micrometers | Standard Deviation 139.84 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 84 | -193.5 Micrometers | Standard Deviation 142.53 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 20 | -183.7 Micrometers | Standard Deviation 139.76 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 88 | -191.0 Micrometers | Standard Deviation 141.29 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 44 | -193.3 Micrometers | Standard Deviation 144.12 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 92 | -193.8 Micrometers | Standard Deviation 142.07 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 8 | -155.4 Micrometers | Standard Deviation 139.09 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 96 | -197.2 Micrometers | Standard Deviation 144.29 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 48 | -172.8 Micrometers | Standard Deviation 141.83 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 100 | -201.4 Micrometers | Standard Deviation 142.9 |
| Brolucizumab 6 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 4 | -128.2 Micrometers | Standard Deviation 131.47 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 100 | -173.9 Micrometers | Standard Deviation 152.03 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 4 | -113.9 Micrometers | Standard Deviation 123.2 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 6 | -126.0 Micrometers | Standard Deviation 124.82 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 8 | -130.8 Micrometers | Standard Deviation 124.71 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 12 | -137.9 Micrometers | Standard Deviation 132.3 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 16 | -145.3 Micrometers | Standard Deviation 132.63 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 18 | -149.0 Micrometers | Standard Deviation 132.28 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 20 | -151.0 Micrometers | Standard Deviation 130.98 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 24 | -134.0 Micrometers | Standard Deviation 136.67 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 28 | -161.4 Micrometers | Standard Deviation 131.27 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 32 | -144.9 Micrometers | Standard Deviation 135.93 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 36 | -162.9 Micrometers | Standard Deviation 135.19 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 40 | -149.9 Micrometers | Standard Deviation 132.66 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 44 | -163.5 Micrometers | Standard Deviation 133.01 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 48 | -154.6 Micrometers | Standard Deviation 130.54 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 52 | -165.0 Micrometers | Standard Deviation 134.77 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 56 | -162.4 Micrometers | Standard Deviation 132.53 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 60 | -166.2 Micrometers | Standard Deviation 132.61 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 64 | -160.2 Micrometers | Standard Deviation 137.83 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 68 | -169.8 Micrometers | Standard Deviation 143.97 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 72 | -165.1 Micrometers | Standard Deviation 141.38 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 76 | -174.7 Micrometers | Standard Deviation 138.7 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 80 | -171.1 Micrometers | Standard Deviation 138.53 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 84 | -175.1 Micrometers | Standard Deviation 139.76 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 88 | -172.2 Micrometers | Standard Deviation 138.08 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 92 | -180.1 Micrometers | Standard Deviation 138.88 |
| Aflibercept 2 mg | Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye | Week 96 | -170.2 Micrometers | Standard Deviation 154.37 |
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.
Time frame: From randomization till 30 days safety follow-up, assessed up to 35 months.
Population: Safety Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Brolucizumab 6 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular adverse events | Moderate | 15 Participants |
| Brolucizumab 6 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-ocular adverse events | Mild | 52 Participants |
| Brolucizumab 6 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular adverse events | Mild | 52 Participants |
| Brolucizumab 6 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-ocular adverse events | Moderate | 51 Participants |
| Brolucizumab 6 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-ocular adverse events | Severe | 33 Participants |
| Brolucizumab 6 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular adverse events | Severe | 6 Participants |
| Aflibercept 2 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-ocular adverse events | Severe | 40 Participants |
| Aflibercept 2 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular adverse events | Mild | 47 Participants |
| Aflibercept 2 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular adverse events | Moderate | 23 Participants |
| Aflibercept 2 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular adverse events | Severe | 4 Participants |
| Aflibercept 2 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-ocular adverse events | Mild | 51 Participants |
| Aflibercept 2 mg | Number of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-ocular adverse events | Moderate | 50 Participants |
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | 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 | Week 24 | 56.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 52 | 61.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 16 | 44.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 56 | 62.0 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 28 | 55.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 60 | 61.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 6 | 34.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 64 | 63.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 32 | 58.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 68 | 62.0 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 18 | 47.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 72 | 63.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 36 | 57.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 76 | 60.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 12 | 43.0 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 80 | 57.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 40 | 58.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 84 | 63.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 20 | 53.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 88 | 61.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 44 | 61.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 92 | 63.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 8 | 39.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 96 | 62.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 48 | 60.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 100 | 61.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 4 | 22.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 100 | 54.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 4 | 23.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 6 | 31.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 8 | 36.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 12 | 45.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 16 | 49.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 18 | 53.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 20 | 56.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 24 | 53.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 28 | 55.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 32 | 51.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 36 | 55.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 40 | 52.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 44 | 56.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 48 | 53.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 52 | 58.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 56 | 54.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 60 | 54.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 64 | 56.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 68 | 57.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 72 | 56.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 76 | 56.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 80 | 55.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 84 | 58.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 88 | 58.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 92 | 58.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 96 | 56.9 Percentage of Participants |
Comparison: Gain of \>= 10 letters in BCVA at Week 5295% CI: [-3.9, 14.7]
Comparison: Gain of \>= 10 letters in BCVA at Week 10095% CI: [-0.4, 19.4]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | 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 | Week 24 | 41.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 52 | 46.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 16 | 33.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 56 | 46.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 28 | 40.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 60 | 46.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 6 | 13.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 64 | 50.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 32 | 44.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 68 | 48.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 18 | 31.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 72 | 48.0 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 36 | 45.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 76 | 46.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 12 | 25.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 80 | 43.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 40 | 44.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 84 | 46.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 20 | 34.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 88 | 47.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 44 | 50.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 92 | 44.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 8 | 25.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 96 | 46.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 48 | 41.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 100 | 49.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 4 | 12.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 100 | 37.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 4 | 9.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 6 | 13.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 8 | 16.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 12 | 22.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 16 | 25.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 18 | 33.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 20 | 32.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 24 | 30.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 28 | 37.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 32 | 30.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 36 | 32.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 40 | 31.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 44 | 35.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 48 | 37.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 52 | 37.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 56 | 35.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 60 | 38.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 64 | 36.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 68 | 35.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 72 | 35.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 76 | 40.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 80 | 37.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 84 | 37.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 88 | 40.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 92 | 40.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 96 | 38.1 Percentage of Participants |
Comparison: Gain of \>= 15 letters in BCVA at Week 5295% CI: [-0.4, 20.2]
Comparison: Gain of \>= 15 letters in BCVA at Week 10095% CI: [3.3, 23.5]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | 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 | Week 24 | 79.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 52 | 77.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 16 | 71.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 56 | 77.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 28 | 75.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 60 | 76.0 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 6 | 62.0 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 64 | 78.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 32 | 77.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 68 | 77.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 18 | 77.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 72 | 79.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 36 | 74.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 76 | 74.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 12 | 70.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 80 | 74.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 40 | 74.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 84 | 78.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 20 | 79.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 88 | 77.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 44 | 74.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 92 | 79.3 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 8 | 67.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 96 | 78.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 48 | 76.0 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 100 | 77.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 4 | 49.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 100 | 73.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 4 | 46.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 6 | 62.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 8 | 63.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 12 | 73.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 16 | 73.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 18 | 77.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 20 | 76.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 24 | 77.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 28 | 77.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 32 | 80.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 36 | 80.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 40 | 79.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 44 | 80.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 48 | 79.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 52 | 79.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 56 | 80.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 60 | 79.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 64 | 79.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 68 | 76.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 72 | 77.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 76 | 77.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 80 | 75.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 84 | 73.5 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 88 | 75.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 92 | 74.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 96 | 73.5 Percentage of Participants |
Comparison: Gain of \>= 5 letters in BCVA at Week 5295% CI: [-7.6, 8.9]
Comparison: Gain of \>= 5 letters in BCVA at Week 10095% CI: [-3.9, 14.5]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | 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 | Week 24 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 52 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 16 | 0.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 56 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 28 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 60 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 6 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 64 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 32 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 68 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 18 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 72 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 36 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 76 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 12 | NA Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 80 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 40 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 84 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 20 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 88 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 44 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 92 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 8 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 96 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 48 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 100 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 4 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 100 | 6.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 4 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 6 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 8 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 12 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 16 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 18 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 20 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 24 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 28 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 32 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 36 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 40 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 44 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 48 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 52 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 56 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 60 | 1.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 64 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 68 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 72 | 1.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 76 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 80 | 1.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 84 | 4.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 88 | 3.9 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 92 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 96 | 3.9 Percentage of Participants |
Comparison: Loss of \>= 10 letters in BCVA at Week 5295% CI: [-3.2, 2.4]
Comparison: Loss of \>= 10 letters in BCVA at Week 10095% CI: [-8.4, -0.1]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | 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 | Week 24 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 52 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 16 | 0.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 56 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 28 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 60 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 6 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 64 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 32 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 68 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 18 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 72 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 36 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 76 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 12 | NA Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 80 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 40 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 84 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 20 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 88 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 44 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 92 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 8 | 0.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 96 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 48 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 100 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 4 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 100 | 3.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 4 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 6 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 8 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 12 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 16 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 18 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 20 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 24 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 28 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 32 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 36 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 40 | NA Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 44 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 48 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 52 | 1.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 56 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 60 | 1.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 64 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 68 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 72 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 76 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 80 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 84 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 88 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 92 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 96 | 2.2 Percentage of Participants |
Comparison: Loss of \>= 15 letters in BCVA at Week 5295% CI: [-3.2, 1.6]
Comparison: Loss of \>= 15 letters in BCVA at Week 10095% CI: [-4.8, 2]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | 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 | Week 24 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 52 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 16 | 0.6 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 56 | 5.0 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 28 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 60 | 3.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 6 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 64 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 32 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 68 | 3.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 18 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 72 | 4.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 36 | 4.5 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 76 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 12 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 80 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 40 | 3.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 84 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 20 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 88 | 3.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 44 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 92 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 8 | 1.1 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 96 | 3.9 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 48 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 100 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | 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 | Week 4 | 3.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 100 | 8.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 4 | 4.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 6 | 3.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 8 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 12 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 16 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 18 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 20 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 24 | 3.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 28 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 32 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 36 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 40 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 44 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 48 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 52 | 3.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 56 | 3.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 60 | 4.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 64 | 3.3 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 68 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 72 | 5.0 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 76 | 4.4 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 80 | 6.1 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 84 | 7.7 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 88 | 7.2 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 92 | 6.6 Percentage of Participants |
| Aflibercept 2 mg | 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 | Week 96 | 7.2 Percentage of Participants |
Comparison: Loss of \>= 5 letters in BCVA at Week 5295% CI: [-4.2, 2.9]
Comparison: Loss of \>= 5 letters in BCVA at Week 10095% CI: [-10.8, -1.7]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 24 | 73.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 52 | 73.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 16 | 69.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 56 | 72.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 28 | 72.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 60 | 70.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 6 | 64.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 64 | 74.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 32 | 73.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 68 | 71.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 18 | 71.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 72 | 73.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 36 | 70.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 76 | 72.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 12 | 66.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 80 | 70.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 40 | 69.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 84 | 70.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 20 | 71.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 88 | 72.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 44 | 73.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 92 | 71.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 8 | 66.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 96 | 70.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 48 | 70.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 100 | 70.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 4 | 55.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 100 | 62.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 4 | 42.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 6 | 49.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 8 | 50.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 12 | 59.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 16 | 60.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 18 | 64.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 20 | 61.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 24 | 60.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 28 | 61.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 32 | 59.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 36 | 65.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 40 | 60.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 44 | 63.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 48 | 61.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 52 | 64.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 56 | 66.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 60 | 66.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 64 | 68.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 68 | 66.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 72 | 65.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 76 | 66.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 80 | 64.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 84 | 65.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 88 | 63.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 92 | 63.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | Week 96 | 62.4 Percentage of Participants |
Comparison: Absolute BCVA \>= 73 letters at Week 5295% CI: [-4.9, 12]
Comparison: Absolute BCVA \>= 73 letters at Week 10095% CI: [-5.4, 12.6]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 60 | 53.1 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 64 | 54.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 68 | 53.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 72 | 56.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 76 | 55.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 80 | 57.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 84 | 57.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 88 | 56.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 92 | 57.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 96 | 59.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 100 | 62.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 4 | 12.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 6 | 16.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 8 | 22.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 12 | 30.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 16 | 36.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 18 | 39.1 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 20 | 42.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 24 | 48.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 28 | 50.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 32 | 48.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 36 | 38.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 40 | 51.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 44 | 51.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 48 | 49.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 52 | 57.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 56 | 57.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 48 | 37.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 12 | 24.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 64 | 38.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 36 | 38.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 68 | 41.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 16 | 29.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 72 | 38.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 56 | 40.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 76 | 42.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 18 | 30.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 80 | 39.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 40 | 37.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 84 | 43.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 20 | 31.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 88 | 41.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 52 | 41.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 92 | 45.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 24 | 29.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 96 | 43.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 44 | 38.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 100 | 47.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 28 | 33.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 4 | 13.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 60 | 40.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 6 | 14.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 32 | 30.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye | Week 8 | 16.7 Percentage of Participants |
Comparison: CSFT thickness (\<280 micrometers) at Week 5295% CI: [5.7, 25.9]
Comparison: CSFT thickness (\<280 micrometers) at Week 10095% CI: [4.2, 24.9]
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.
Time frame: Week 52, Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Participants With Presence of Leakage on Fluorescein Angiography (FA) at Weeks 52 and 100 | Week 52 | 54.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With Presence of Leakage on Fluorescein Angiography (FA) at Weeks 52 and 100 | Week 100 | 46.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Presence of Leakage on Fluorescein Angiography (FA) at Weeks 52 and 100 | Week 52 | 79.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Presence of Leakage on Fluorescein Angiography (FA) at Weeks 52 and 100 | Week 100 | 65.6 Percentage of Participants |
Comparison: Fluorescein Angiography (FA) at Week 10095% CI: [-29.1, -8.2]
Comparison: Fluorescein Angiography (FA) at Week 5295% CI: [-34.4, -16.3]
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.
Time frame: Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | Percentage of Participants With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS-DRSS Score of at Least 61 by Week 100 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS-DRSS Score of at Least 61 by Week 100 | 0.6 Percentage of Participants |
Comparison: Proliferative diabetic retinopathy (PDR) of at least 61 by Week 10095% CI: [-2.1, 1.9]
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 28 | 25.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 52 | 29.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 76 | 30.1 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 100 | 35.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 100 | 31.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 28 | 20.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 76 | 30.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 52 | 27.7 Percentage of Participants |
Comparison: \>=2-step improvement in ETDRS-DRSS at Week 5295% CI: [-5.6, 7.8]
Comparison: \>=2-step improvement in ETDRS-DRSS at Week 10095% CI: [-1.7, 10.8]
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 28 | 2.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 52 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 76 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 100 | 4.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 100 | 1.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 28 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 76 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 52 | 0.6 Percentage of Participants |
Comparison: \>=2-step worsening in ETDRS-DRSS at Week 5295% CI: [-1, 3.6]
Comparison: \>=2-step worsening in ETDRS-DRSS at Week 10095% CI: [-0.5, 6.9]
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 28 | 13.1 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 52 | 14.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 76 | 18.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 100 | 21.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 100 | 16.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 28 | 11.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 76 | 15.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 52 | 15.3 Percentage of Participants |
Comparison: \>=3-step improvement in ETDRS-DRSS at Week 5295% CI: [-7.1, 5.7]
Comparison: \>=3-step improvement in ETDRS-DRSS at Week 10095% CI: [-2.3, 10]
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.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 100 | 0.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 52 | 0.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 28 | 0.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 76 | 0.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 28 | NA Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 100 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 76 | NA Percentage of Participants |
| Aflibercept 2 mg | Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score | Week 52 | NA Percentage of Participants |
Comparison: \>=3-step worsening in ETDRS-DRSS at Week 5295% CI: [0.5, 2.1]
Comparison: \>=3-step worsening in ETDRS-DRSS at Week 10095% CI: [-2.6, 1.3]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 24 | 69.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 52 | 53.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 16 | 76.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 56 | 51.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 28 | 67.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 60 | 55.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 6 | 85.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 64 | 48.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 32 | 67.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 68 | 47.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 18 | 77.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 72 | 45.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 36 | 73.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 76 | 50.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 12 | 83.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 80 | 45.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 40 | 57.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 84 | 40.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 20 | 72.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 88 | 48.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 44 | 56.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 92 | 44.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 8 | 87.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 96 | 41.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 48 | 60.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 100 | 40.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 4 | 88.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 100 | 56.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 4 | 89.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 6 | 86.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 8 | 84.5 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 12 | 85.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 16 | 84.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 18 | 81.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 20 | 79.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 24 | 82.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 28 | 75.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 32 | 76.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 36 | 72.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 40 | 74.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 44 | 71.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 48 | 75.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 52 | 72.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 56 | 70.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 60 | 69.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 64 | 69.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 68 | 66.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 72 | 66.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 76 | 63.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 80 | 65.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 84 | 63.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 88 | 64.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 92 | 59.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 96 | 61.9 Percentage of Participants |
Comparison: Intraretinal Fluid (IRF) at Week 5295% CI: [-28.9, -9.2]
Comparison: Intraretinal Fluid (IRF) at Week 10095% CI: [-26.3, -5.7]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 84 | 40.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 44 | 57.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 88 | 48.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 60 | 55.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 92 | 45.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 32 | 68.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 96 | 41.3 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 64 | 49.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 100 | 40.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 48 | 61.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 68 | 48.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 20 | 73.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 40 | 58.1 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 24 | 70.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 72 | 46.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 28 | 68.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 52 | 54.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 4 | 90.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 76 | 50.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 6 | 86.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 36 | 73.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 8 | 87.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 80 | 46.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 12 | 83.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 56 | 52.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 16 | 76.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 18 | 78.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 16 | 84.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 32 | 76.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 36 | 72.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 40 | 74.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 44 | 71.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 48 | 75.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 52 | 72.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 56 | 70.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 60 | 69.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 64 | 69.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 68 | 68.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 72 | 66.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 76 | 63.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 80 | 65.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 84 | 63.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 88 | 64.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 92 | 59.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 96 | 61.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 100 | 56.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 18 | 81.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 20 | 79.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 24 | 82.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 28 | 75.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 4 | 90.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 6 | 88.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 8 | 85.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit | Week 12 | 86.2 Percentage of Participants |
Comparison: Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 5295% CI: [-28.5, -8.3]
Comparison: Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 10095% CI: [-26.4, -5.9]
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.
Time frame: 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
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 24 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 52 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 16 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 56 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 28 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 60 | 2.8 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 6 | 10.1 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 64 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 32 | 5.0 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 68 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 18 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 72 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 36 | 6.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 76 | 3.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 12 | 3.9 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 80 | 4.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 40 | 4.5 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 84 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 20 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 88 | 3.4 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 44 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 92 | 1.7 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 8 | 5.6 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 96 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 48 | 6.1 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 100 | 2.2 Percentage of Participants |
| Brolucizumab 6 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 4 | 12.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 100 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 4 | 19.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 6 | 13.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 8 | 12.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 12 | 7.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 16 | 3.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 18 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 20 | 3.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 24 | 6.6 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 28 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 32 | 3.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 36 | 1.7 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 40 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 44 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 48 | 5.0 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 52 | 3.3 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 56 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 60 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 64 | 3.9 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 68 | 4.4 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 72 | 2.8 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 76 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 80 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 84 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 88 | 2.2 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 92 | 1.1 Percentage of Participants |
| Aflibercept 2 mg | Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit | Week 96 | 2.8 Percentage of Participants |
Comparison: Subretinal Fluid (SRF) at Week 5295% CI: [-4.5, 2.1]
Comparison: Subretinal Fluid (SRF) at Week 10095% CI: [-3.4, 3.4]
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.
Time frame: Up to Week 100
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Brolucizumab 6 mg | Pre-existing ADA Status and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye | Negative | At least 1 AESI | 1 Participants |
| Brolucizumab 6 mg | Pre-existing ADA Status and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye | Negative | No AESI | 63 Participants |
| Brolucizumab 6 mg | Pre-existing ADA Status and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye | Postive | At least 1 AESI | 5 Participants |
| Brolucizumab 6 mg | Pre-existing ADA Status and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye | Postive | No AESI | 105 Participants |
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.
Time frame: Up to Week 24
Population: Safety Set. Data after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Systemic Brolucizumab Concentration | Day 2 | 56.2 ng/mL | Standard Deviation 10.4 |
| Brolucizumab 6 mg | Systemic Brolucizumab Concentration | Week 4 | 0.760 ng/mL | Standard Deviation 1.98 |
| Brolucizumab 6 mg | Systemic Brolucizumab Concentration | Week 12 | NA ng/mL | — |
| Brolucizumab 6 mg | Systemic Brolucizumab Concentration | Week 24 | NA ng/mL | — |
| Brolucizumab 6 mg | Systemic Brolucizumab Concentration | Week 24 + 1 Day | 41.5 ng/mL | Standard Deviation 80.5 |