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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001004-37 | EudraCT Number |
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The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).
This study was designed as a Phase III, multi-center, randomized, double-masked, active controlled, parallel group prospective study to evaluate if brolucizumab 6 mg dosed q4w is safe and effective in the treatment of subjects with visual impairment due to diabetic macular edema (DME). Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 2:1 ratio to one of two treatment arms i.e., brolucizumab 6 mg and aflibercept 2 mg. Only one eye was selected as study eye and treated with study medication.
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 48). For all subjects, the last study assessment was performed at the Week 52/end of study (EOS) visit. All subjects had study visits q4w through Week 52. The primary analysis was performed at the EOS visit (Week 52).
To ensure masking was maintained, the investigational site had both masked and unmasked staff to perform the masked and unmasked study assessments/procedures accordingly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab 6mg q4w | Experimental | Brolucizumab 6 mg/0.05 mL every 4 weeks. |
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| Aflibercept 2mg q4w | Active Comparator | Aflibercept 2mg/0.05 mL every 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab | Drug | Intravitreal injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Central Subfield Thickness assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit |
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Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study.
Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening.
Study eye: Visual impairment due to DME with:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85016 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37971723 | Derived | Singh RP, Barakat MR, Ip MS, Wykoff CC, Eichenbaum DA, Joshi S, Warrow D, Sheth VS, Stefanickova J, Kim YS, He F, Cho GE, Wang Y, Emanuelli A. Efficacy and Safety of Brolucizumab for Diabetic Macular Edema: The KINGFISHER Randomized Clinical Trial. JAMA Ophthalmol. 2023 Dec 1;141(12):1152-1160. doi: 10.1001/jamaophthalmol.2023.5248. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of the patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to criteria and process described on www.clinicalstudydatarequest.com
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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 48). For all subjects, the last study assessment was performed at the Week 52/end of study (EOS) visit. All subjects had study visits q4w through Week 52. The primary analysis was performed at the EOS visit (Week 52).
Study centers (no. of sites): Hungary (5), Israel (5), Slovakia (7), United States (78).
Approximately, 495 subjects were planned to be randomized. Overall, 517 subjects were randomized either to brolucizumab 6 mg q4w arm (n=346) or aflibercept 2 mg q4w arm (n=171).
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| ID | Title | Description |
|---|---|---|
| FG000 | Brolucizumab 6mg q4w | Brolucizumab 6 mg/0.05 mL every 4 weeks. |
| FG001 | Aflibercept 2mg q4w | Aflibercept 2mg/0.05 mL every 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2020 | Mar 23, 2022 |
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A masked evaluating investigator will be responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator was to perform the injections and assess patient safety following the injections.
| Aflibercept | Drug | Intravitreal injection |
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Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with simultaneous absence of SRF and IRF in the study eye by visit. Events and censoring after 52 weeks are included in week 52 row. |
| Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Baseline, Week 52 |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning. Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment. | Baseline, Weeks 12, 24 and 52 |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning. Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment. | Baseline, Weeks 12, 24 and 52 |
| Anti-Drug Antibody (ADA): Frequency Distribution of Pre-existing ADA Status in the Brolucizumab Arm | Baseline |
| Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks. |
| Number of Subjects With Non-ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks. |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Novartis Investigative Site | Tucson | Arizona | 85704-5614 | United States |
| Novartis Investigative Site | Beverly Hills | California | 90211 | United States |
| Novartis Investigative Site | Campbell | California | 95008 | United States |
| Novartis Investigative Site | Fresno | California | 93720 | United States |
| Novartis Investigative Site | Huntington Beach | California | 92647 | United States |
| Novartis Investigative Site | Loma Linda | California | 92354 | United States |
| Novartis Investigative Site | Mountain View | California | 94040 | United States |
| Novartis Investigative Site | Oakland | California | 94609 | United States |
| Novartis Investigative Site | Pasadena | California | 91107 | United States |
| Novartis Investigative Site | Poway | California | 92064 | United States |
| Novartis Investigative Site | Rancho Cordova | California | 95670 | United States |
| Novartis Investigative Site | Redlands | California | 92374 | United States |
| Novartis Investigative Site | Riverside | California | 92505 | United States |
| Novartis Investigative Site | Sacramento | California | 95817 | United States |
| Novartis Investigative Site | Sacramento | California | 95841 | United States |
| Novartis Investigative Site | San Francisco | California | 94107 | United States |
| Novartis Investigative Site | Santa Ana | California | 92705 | United States |
| Novartis Investigative Site | Santa Barbara | California | 93103 | United States |
| Novartis Investigative Site | Torrance | California | 90509-2910 | United States |
| Novartis Investigative Site | Ventura | California | 93003 | United States |
| Novartis Investigative Site | Altamonte Springs | Florida | 32701 | United States |
| Novartis Investigative Site | Deerfield Beach | Florida | 33064 | United States |
| Novartis Investigative Site | Fort Lauderdale | Florida | 33309 | United States |
| Novartis Investigative Site | Fort Myers | Florida | 33912-7125 | United States |
| Novartis Investigative Site | Orlando | Florida | 32804 | United States |
| Novartis Investigative Site | Pinellas Park | Florida | 33782 | United States |
| Novartis Investigative Site | St. Petersburg | Florida | 33711 | United States |
| Novartis Investigative Site | Tampa | Florida | 33609 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30342 | United States |
| Novartis Investigative Site | Marietta | Georgia | 30060 | United States |
| Novartis Investigative Site | ‘Aiea | Hawaii | 96701 | United States |
| Novartis Investigative Site | Bloomington | Illinois | 61704 | United States |
| Novartis Investigative Site | Oak Forest | Illinois | 60452 | United States |
| Novartis Investigative Site | Springfield | Illinois | 62704 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46280 | United States |
| Novartis Investigative Site | New Albany | Indiana | 47150 | United States |
| Novartis Investigative Site | West Des Moines | Iowa | 50266 | United States |
| Novartis Investigative Site | Leawood | Kansas | 66211 | United States |
| Novartis Investigative Site | Lenexa | Kansas | 66215 | United States |
| Novartis Investigative Site | Hagerstown | Maryland | 21740 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | United States |
| Novartis Investigative Site | Royal Oak | Michigan | 48073 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55435 | United States |
| Novartis Investigative Site | Kansas City | Missouri | 64133 | United States |
| Novartis Investigative Site | Reno | Nevada | 89502 | United States |
| Novartis Investigative Site | Bloomfield | New Jersey | 07003 | United States |
| Novartis Investigative Site | Teaneck | New Jersey | 07666 | United States |
| Novartis Investigative Site | Rochester | New York | 14620 | United States |
| Novartis Investigative Site | Hickory | North Carolina | 28602 | United States |
| Novartis Investigative Site | Southern Pines | North Carolina | 28387 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44122 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43210 | United States |
| Novartis Investigative Site | Dublin | Ohio | 43016 | United States |
| Novartis Investigative Site | Eugene | Oregon | 97401 | United States |
| Novartis Investigative Site | Kingston | Pennsylvania | 95403 | United States |
| Novartis Investigative Site | Chattanooga | Tennessee | 37421 | United States |
| Novartis Investigative Site | Germantown | Tennessee | 38138 | United States |
| Novartis Investigative Site | Abilene | Texas | 79606 | United States |
| Novartis Investigative Site | Austin | Texas | 78705 | United States |
| Novartis Investigative Site | Austin | Texas | 78731 | United States |
| Novartis Investigative Site | Austin | Texas | 78750 | United States |
| Novartis Investigative Site | Bellaire | Texas | 77401 | United States |
| Novartis Investigative Site | Dallas | Texas | 75231 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | United States |
| Novartis Investigative Site | Harlingen | Texas | 78550 | United States |
| Novartis Investigative Site | Houston | Texas | 77025 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78240 | United States |
| Novartis Investigative Site | Southlake | Texas | 76092 | United States |
| Novartis Investigative Site | Norfolk | Virginia | 23502 | United States |
| Novartis Investigative Site | Morgantown | West Virginia | 26506 | United States |
| Novartis Investigative Site | Madison | Wisconsin | 53705-3611 | United States |
| Novartis Investigative Site | Pécs | Baranya | 7621 | Hungary |
| Novartis Investigative Site | Zalaegerszeg | Zala County | 8900 | Hungary |
| Novartis Investigative Site | Budapest | 1083 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Szeged | H 6725 | Hungary |
| Novartis Investigative Site | Haifa | 3339419 | Israel |
| Novartis Investigative Site | Haifa | 3436212 | Israel |
| Novartis Investigative Site | Kfar Saba | 4428164 | Israel |
| Novartis Investigative Site | Petah Tikva | 4941492 | Israel |
| Novartis Investigative Site | Tel Aviv | 6789140 | Israel |
| Novartis Investigative Site | Arecibo | 00612 | Puerto Rico |
| Novartis Investigative Site | Banská Bystrica | 97517 | Slovakia |
| Novartis Investigative Site | Bratislava | 82606 | Slovakia |
| Novartis Investigative Site | Bratislava | 85107 | Slovakia |
| Novartis Investigative Site | Poprad | 058 45 | Slovakia |
| Novartis Investigative Site | Trebišov | 075 01 | Slovakia |
| Novartis Investigative Site | Trenčín | 91171 | Slovakia |
| Novartis Investigative Site | Zvolen | 960 01 | Slovakia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab 6mg q4w | Brolucizumab 6 mg/0.05 mL every 4 weeks. |
| BG001 | Aflibercept 2mg q4w | Aflibercept 2mg/0.05 mL every 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Central Subfield Thickness assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Least Squares Mean | 95% Confidence Interval | μm | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
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| Secondary | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with simultaneous absence of SRF and IRF in the study eye by visit. Events and censoring after 52 weeks are included in week 52 row. | Full analysis set (FAS) - Last observation carried forward (LOCF). | Posted | Count of Participants | Participants | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
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| Secondary | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Count of Participants | Participants | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
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| Secondary | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. | Full Analysis Set. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. | Posted | Number | Participants | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
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| Secondary | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. | Full Analysis Set. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. | Posted | Number | 95% Confidence Interval | Probability of absence of SRF/IRF | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
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| Secondary | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. | Full Analysis Set | Posted | Number | Participants | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
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| Secondary | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Probability of absence of DME | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
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| Secondary | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Count of Participants | Participants | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning. Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF). Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded from analysis. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 12, 24 and 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning. Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment. | Full analysis set (FAS) - Last observation carried forward (LOCF). Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded from analysis. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 12, 24 and 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-Drug Antibody (ADA): Frequency Distribution of Pre-existing ADA Status in the Brolucizumab Arm | Safety Set | Posted | Count of Participants | Participants | Baseline |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Safety Set | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Non-ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) | Safety Set | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks. |
|
|
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brolucizumab 6mg | Brolucizumab 6mg | 7 | 346 | 74 | 346 | 144 | 346 |
| EG001 | Aflibercept 2mg | Aflibercept 2mg | 5 | 171 | 36 | 171 | 92 | 171 |
| EG002 | Overall | Overall | 12 | 517 | 110 | 517 | 236 | 517 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cataract - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cataract subcapsular - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetic retinopathy - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Retinal vasculitis - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vitreous haemorrhage - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vitreous haemorrhage - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abscess bacterial | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Anastomotic ulcer haemorrhage | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Cataract operation complication - Fellow eye | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombotic stroke | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetic wound | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cataract - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cataract - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetic retinal oedema - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetic retinal oedema - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dry eye - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dry eye - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Eye pain - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Eye pain - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Punctate keratitis - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Uveitis - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vitreous detachment - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vitreous floaters - Study eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vitreous haemorrhage - Fellow eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Corneal abrasion - Study eye | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2021 | Mar 23, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| <0.001 |
| Non-Inferiority |
(4-letter margin) (1-sided) |
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
Brolucizumab 6 mg/0.05 mL every 4 weeks.
| OG001 | Aflibercept 2mg q4w | Aflibercept 2mg/0.05 mL every 4 weeks |
|
|
|
Brolucizumab 6 mg/0.05 mL every 4 weeks.
| OG001 | Aflibercept 2mg q4w | Aflibercept 2mg/0.05 mL every 4 weeks |
|
|
|
| Negative |
|
| Positive |
|
|
|