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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000716-28 | EudraCT Number |
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This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.
At the baseline Visit, subjects who met the eligibility criteria were randomized in a 1:1 ratio to receive either: -Brolucizumab 6 mg: 3 × 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62
-Aflibercept 2 mg: 3 × 4-week injections and one 8-week injection, followed by Treat-to-Control treatment from Week 16 up to Week 60/62.
For all subjects, the last potential study treatment was at the Week 60 visit (or at the Week 62 visit for subjects whose actual treatment interval would require a treatment at Week 62). The initiation phase starts on Day 1 and ends on Week 16. Treat to Control regimen starts on Week 16 until end of treatment (Week 60/62).
In both treatment arms, treatment intervals after the initiation phase were either 8 weeks, 12 weeks, or 16 weeks. Per the original protocol, if it was determined that a patient required more frequent injections than q8w, he/she would be moved to a q4w treatment interval. However, this option was removed per Protocol amendment 02, after which, dosing intervals shorter than q8w were not permitted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab 6 mg | Experimental | 3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62. |
|
| Aflibercept 2 mg | Active Comparator | 3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab 6 mg | Biological | Intra-vitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. Intraretinal Fluid (IRF), Subretinal Fluid (SRF), hemorrhage, leakage, etc.). Treatment interval distribution. Number (%) of subjects at 12/8/4-weeks intervals up to Week 32 for the study eye. If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or ≥12-week then the floor value of these ranges was used. | Up to Week 32 |
| Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. Least squares mean estimate - for weeks 28 and 32 combined. | Baseline, Week 28 and Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). Treatment interval distribution. The number of subjects at 16/12/8/4-weeks intervals as the last interval with no disease activity. If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or (12-weeks, 16-weeks) or ≥16-week then the floor value of these ranges was used. |
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Inclusion Criteria:
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 | 85020 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.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 patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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734 participants were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brolucizumab 6 mg | Intra-vitreal injection |
| FG001 | Aflibercept 2 mg | Intra-vitreal injection |
| 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 | Sep 23, 2021 | Aug 31, 2023 |
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Double arm, multi-center
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| Aflibercept 2 mg | Biological | Intra-vitreal injection |
|
|
| Up to Week 64 |
| Distribution of the Maximal Intervals With no Disease Activity up to Week 64 - Study Eye | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). Maximal interval distribution. Number of subjects at 16/12/8/4-weeks intervals as the last interval with no disease activity. If the study treatment is discontinued before Week 16 included, then the treatment interval is 4 weeks; otherwise, the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the maximal interval falls within the following ranges of [4-weeks, 8-weeks) or [8-weeks, 12-weeks) or [12-weeks, 16-weeks] or ≥16-weeks then the floor value of these ranges is used.](streamdown:incomplete-link) | Up to Week 64 |
| Number of Participants With no Disease Activity - Study Eye | Disease activity assessment as determined by visual acuity and assessment of other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). | Weeks 14 and 16 |
| Time From Last Loading Injection to First Visit With No Disease Activity (Weeks) - 75th Percentile - Study Eye | Intraretinal fluid (IRF) and subretinal fluid (SRF) were assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye). Please note that this endpoint can be impacted by the optional disease activity assessment visits and the flexible dosing regimen, in addition to the randomized treatment. Hence, the observed treatment effect may be confounded by the study design artifacts. | Up to Week 64 |
| Time-to-first Dry Retina - Time to the First Visit With no Intraretinal Fluid (IRF) or Subretinal Fluid (SRF) - Study Eye | Intraretinal fluid (IRF) and subretinal fluid (SRF) were assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye). | Up to Week 64 |
| Average Change From Baseline at Week 60 and Week 64 in Best-corrected Visual Acuity (BCVA) - Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. Least squares mean estimate - for weeks 60 and 64 combined. | Baseline, Week 60 and Week 64 |
| Number of Participants With Best-corrected Visual Acuity Improvements of ≥ 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters up to Week 32/64 Per Treatment Arm - Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Baseline, Week 32, and Week 64 |
| Number of Participants With Best-corrected Visual Acuity ≥ 69 Letters - Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Week 32 and Week 64 |
| Average Change From Baseline in Central Subfield Thickness (CSFT) - Study Eye | CSFT was measured by Spectral Domain Optical Coherence Tomography | Baseline, Weeks 28 and 32 and at Weeks 60 and 64 |
| Number of Participants With Presence of Intraretinal Fluid and/or Subretinal Fluid in the Central Subfield - Study Eye | Intraretinal Fluid and/or Subretinal Fluid status was measured by Spectral Domain Optical Coherence Tomography (SD-OCT). | At Weeks 28, 32, 60 and 64 |
| Number of Participants With Presence of Sub-Retinal Pigment Epithelium Fluid in the Central Subfield - Study Eye | Sub-Retinal Pigment Epithelium fluid status was measured by Spectral Domain Optical Coherence Tomography (SD-OCT). | At Weeks 28, 32, 60 and 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Composite Scores - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - General Vision - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Ocular Pain - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline n Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Near Activities - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Distance Activities - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Social Functioning - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Mental Health - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Role Difficulties - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Dependency - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Driving - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Color Vision - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Peripheral Vision - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Baseline, Week 32, and Week 64 |
| Number of Participants With Treatment Emergent Ocular Adverse Events (Greater Than or Equal to 1% in Any Treatment Arm) by Preferred Term for the Study Eye | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject. | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years. |
| Number of Participants With Treatment Emergent Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) - Summary Table | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject. | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years. |
| Huntington Beach |
| California |
| 92647 |
| United States |
| Novartis Investigative Site | Loma Linda | California | 92354 | United States |
| Novartis Investigative Site | Riverside | California | 92505 | United States |
| Novartis Investigative Site | Santa Ana | California | 92705 | 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 | 32789 | United States |
| Novartis Investigative Site | Pinellas Park | Florida | 33782 | United States |
| Novartis Investigative Site | Winter Haven | Florida | 33880 | United States |
| Novartis Investigative Site | Springfield | Illinois | 62704 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46280 | United States |
| Novartis Investigative Site | West Des Moines | Iowa | 50266 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55435 | United States |
| Novartis Investigative Site | Hickory | North Carolina | 28602 | United States |
| Novartis Investigative Site | Portland | Oregon | 97210 | United States |
| Novartis Investigative Site | Springfield | Oregon | 97477 | United States |
| Novartis Investigative Site | Germantown | Tennessee | 38138 | United States |
| Novartis Investigative Site | Austin | Texas | 78705 | United States |
| Novartis Investigative Site | Bellaire | Texas | 77401 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | 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 | Caba | Buenos Aires | 1116 | Argentina |
| Novartis Investigative Site | Ciudad Autonoma de Bs As | Buenos Aires | C1015ABO | Argentina |
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| Novartis Investigative Site | Parramatta | New South Wales | 2150 | Australia |
| Novartis Investigative Site | Sydney | New South Wales | 2000 | Australia |
| Novartis Investigative Site | Southport | Queensland | 4215 | Australia |
| Novartis Investigative Site | Glen Waverley | Victoria | 3150 | Australia |
| Novartis Investigative Site | Rowville | Victoria | 3179 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Vienna | 1090 | Austria |
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| Novartis Investigative Site | Brampton | Ontario | L6Y 0P6 | Canada |
| Novartis Investigative Site | London | Ontario | N6A 4G5 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M4N 3M5 | Canada |
| Novartis Investigative Site | Boisbriand | Quebec | J7H 1S6 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1S 4L8 | Canada |
| Novartis Investigative Site | Zlín | Czech Republic | 762 75 | Czechia |
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| Novartis Investigative Site | Ostrava Poruba | 708 52 | Czechia |
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| Novartis Investigative Site | Prague | 12808 | Czechia |
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| Novartis Investigative Site | Leipzig | 04103 | Germany |
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| Novartis Investigative Site | Jerusalem | 9112001 | Israel |
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| Novartis Investigative Site | Shah Alam | Selangor | 40000 | Malaysia |
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| Novartis Investigative Site | Vila Franca de Xira | 2600-009 | Portugal |
| Novartis Investigative Site | Bundang Gu | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Seoul | Seocho Gu | 06591 | South Korea |
| Novartis Investigative Site | Busan | 49241 | South Korea |
| Novartis Investigative Site | Daegu | 705703 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
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| Novartis Investigative Site | Barcelona | Catalonia | 08022 | Spain |
| Novartis Investigative Site | Sant Cugat del Vallès | Catalonia | 08190 | Spain |
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| Novartis Investigative Site | Örebro | 701 85 | Sweden |
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| Novartis Investigative Site | Taipei | 103616 | Taiwan |
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| Novartis Investigative Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | London | EC1V 2PD | United Kingdom |
| Novartis Investigative Site | Rugby | CV22 5PX | United Kingdom |
| Novartis Investigative Site | Sunderland | SR2 9HP | United Kingdom |
| Novartis Investigative Site | Torquay | TQ2 7AA | United Kingdom |
| Novartis Investigative Site | Wolverhampton | WV10 0QP | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab 6 mg | Intra-vitreal injection |
| BG001 | Aflibercept 2 mg | Intra-vitreal injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 | Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. Intraretinal Fluid (IRF), Subretinal Fluid (SRF), hemorrhage, leakage, etc.). Treatment interval distribution. Number (%) of subjects at 12/8/4-weeks intervals up to Week 32 for the study eye. If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or ≥12-week then the floor value of these ranges was used. | Full Analysis Set (Includes participants who were randomized and treated.) | Posted | Count of Participants | Participants | Up to Week 32 |
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| Primary | Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. Least squares mean estimate - for weeks 28 and 32 combined. | Full Analysis Set - Last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 28 and Week 32 |
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| Secondary | Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). Treatment interval distribution. The number of subjects at 16/12/8/4-weeks intervals as the last interval with no disease activity. If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or (12-weeks, 16-weeks) or ≥16-week then the floor value of these ranges was used. | Full Analysis Set | Posted | Count of Participants | Participants | Up to Week 64 |
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| Secondary | Distribution of the Maximal Intervals With no Disease Activity up to Week 64 - Study Eye | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). Maximal interval distribution. Number of subjects at 16/12/8/4-weeks intervals as the last interval with no disease activity. If the study treatment is discontinued before Week 16 included, then the treatment interval is 4 weeks; otherwise, the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the maximal interval falls within the following ranges of [4-weeks, 8-weeks) or [8-weeks, 12-weeks) or [12-weeks, 16-weeks] or ≥16-weeks then the floor value of these ranges is used.](streamdown:incomplete-link) | Full Analysis Set | Posted | Count of Participants | Participants | Up to Week 64 |
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| Secondary | Number of Participants With no Disease Activity - Study Eye | Disease activity assessment as determined by visual acuity and assessment of other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). | Full Analysis Set. Note that the number analyzed is reduced because the Week 14 visit was conducted at the investigator's discretion, and because some patients had already stopped treatment by Week 16. | Posted | Count of Participants | Participants | Weeks 14 and 16 |
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| Secondary | Time From Last Loading Injection to First Visit With No Disease Activity (Weeks) - 75th Percentile - Study Eye | Intraretinal fluid (IRF) and subretinal fluid (SRF) were assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye). Please note that this endpoint can be impacted by the optional disease activity assessment visits and the flexible dosing regimen, in addition to the randomized treatment. Hence, the observed treatment effect may be confounded by the study design artifacts. | Full Analysis Set - subjects with no important protocol deviations with impact | Posted | Number | 95% Confidence Interval | weeks | Up to Week 64 |
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| Secondary | Time-to-first Dry Retina - Time to the First Visit With no Intraretinal Fluid (IRF) or Subretinal Fluid (SRF) - Study Eye | Intraretinal fluid (IRF) and subretinal fluid (SRF) were assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye). | Full Analysis Set - subjects with no important protocol deviations with impact | Posted | Number | Participants | Up to Week 64 |
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| Secondary | Average Change From Baseline at Week 60 and Week 64 in Best-corrected Visual Acuity (BCVA) - Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. Least squares mean estimate - for weeks 60 and 64 combined. | Full Analysis Set - LOCF | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 60 and Week 64 |
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| Secondary | Number of Participants With Best-corrected Visual Acuity Improvements of ≥ 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters up to Week 32/64 Per Treatment Arm - Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set - LOCF | Posted | Count of Participants | Participants | Baseline, Week 32, and Week 64 |
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| Secondary | Number of Participants With Best-corrected Visual Acuity ≥ 69 Letters - Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set - LOCF | Posted | Count of Participants | Participants | Week 32 and Week 64 |
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| Secondary | Average Change From Baseline in Central Subfield Thickness (CSFT) - Study Eye | CSFT was measured by Spectral Domain Optical Coherence Tomography | Full Analysis Set - LOCF | Posted | Least Squares Mean | Standard Error | micrometers | Baseline, Weeks 28 and 32 and at Weeks 60 and 64 |
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| Secondary | Number of Participants With Presence of Intraretinal Fluid and/or Subretinal Fluid in the Central Subfield - Study Eye | Intraretinal Fluid and/or Subretinal Fluid status was measured by Spectral Domain Optical Coherence Tomography (SD-OCT). | Full Analysis Set | Posted | Count of Participants | Participants | At Weeks 28, 32, 60 and 64 |
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| Secondary | Number of Participants With Presence of Sub-Retinal Pigment Epithelium Fluid in the Central Subfield - Study Eye | Sub-Retinal Pigment Epithelium fluid status was measured by Spectral Domain Optical Coherence Tomography (SD-OCT). | Full Analysis Set | Posted | Count of Participants | Participants | At Weeks 28, 32, 60 and 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Composite Scores - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - General Vision - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Ocular Pain - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline n Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Near Activities - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Distance Activities - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Social Functioning - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Mental Health - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Role Difficulties - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Dependency - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Driving - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Color Vision - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Peripheral Vision - Study Eye | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 32, and Week 64 |
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| Secondary | Number of Participants With Treatment Emergent Ocular Adverse Events (Greater Than or Equal to 1% in Any Treatment Arm) by Preferred Term for the Study Eye | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject. | Safety Analysis set | Posted | Count of Participants | Participants | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years. |
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| Secondary | Number of Participants With Treatment Emergent Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) - Summary Table | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject. | Safety Analysis set | Posted | Count of Participants | Participants | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years. |
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Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years.
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 | Intra-vitreal injection | 4 | 366 | 58 | 366 | 172 | 366 |
| EG001 | Aflibercept 2mg | Intra-vitreal injection | 2 | 368 | 53 | 368 | 177 | 368 |
| EG002 | All Patients | All Patients | 6 | 734 | 111 | 734 | 349 | 734 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
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| Eye inflammation - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Glaucoma - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Iridocyclitis - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Macular hole - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Ocular discomfort - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Ocular discomfort - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Retinal artery occlusion - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Retinal vascular occlusion - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Retinal vein occlusion - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Uveitis - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Visual acuity reduced - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal adhesions | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Endophthalmitis - Study Eye | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Escherichia sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Face injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Stress fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Intraocular pressure increased - Study Eye | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Basal ganglia infarction | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Psychotic disorder due to a general medical condition | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Peripheral artery aneurysm rupture | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cataract - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Choroidal neovascularisation - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Detachment of retinal pigment epithelium - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dry eye - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dry eye - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Eye pain - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Eye pain - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Eye pruritus - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Foreign body sensation in eyes - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lacrimation increased - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Macular oedema - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Posterior capsule opacification - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal depigmentation - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal haemorrhage - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal oedema - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal pigment epithelial tear - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Subretinal fibrosis - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Subretinal fluid - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vision blurred - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Visual acuity reduced - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Visual acuity reduced - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vitreous detachment - Fellow Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vitreous detachment - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vitreous floaters - Study Eye | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctivitis - Fellow Eye | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctivitis - Study Eye | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Hordeolum - Study Eye | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Intra-ocular injection complication - Study Eye | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Intraocular pressure increased - Study Eye | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | 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 | Oct 20, 2022 | Aug 31, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057135 | Wet Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D014786 | Vision Disorders |
| D057092 | Geographic Atrophy |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
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 |
|
| 4 weeks |
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