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The purpose of this study was to compare the development of new geographic atrophy in patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result in the progressive and irreversible loss of visual function over time.
In each arm, patients underwent three monthly loading doses (at Baseline, Week 4, and Week 8). From Week 8, after the patient had received their third injection of study treatment, the visit intervals were determined by the patient's disease activity. If any of the protocol-specified signs of disease activity were present in the study eye, the subsequent injection visit interval was kept at 4 weeks. If none of the signs were present, the subsequent injection interval was extended by 2-week increments up until a maximum of 12-weekly intervals was reached. If there were any signs of disease activity in the study eye, the treatment interval was reduced as specified in the protocol. The planned individual duration of study participation was 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5 mg | Experimental | 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend] |
|
| Aflibercept 2.0 mg | Active Comparator | 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Drug | Administered as an intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24 | Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis. | Baseline, Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12 | Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis. |
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Inclusion criteria:
- Written informed consent.
Inclusion criteria specific to the study eye:
Exclusion criteria:
Exclusion criteria specific to the study eye:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Albury | New South Wales | 2640 | Australia | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32374423 | Derived | Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2. | |
| 30676617 | Derived | Gillies MC, Hunyor AP, Arnold JJ, Guymer RH, Wolf S, Ng P, Pecheur FL, McAllister IL. Effect of Ranibizumab and Aflibercept on Best-Corrected Visual Acuity in Treat-and-Extend for Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Apr 1;137(4):372-379. doi: 10.1001/jamaophthalmol.2018.6776. |
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This reporting group includes all patients randomized to treatment.
Patients were recruited and enrolled from 24 sites located in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab 0.5 mg | 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend] |
| FG001 | Aflibercept 2.0 mg |
| 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 | Jan 19, 2015 | Oct 23, 2018 |
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Investigators were not masked. The patients, the BCVA assessors, and the Central Reading Center (who set the treatment intervals) were masked.
| Aflibercept 2.0 mg | Drug | Administered as an intravitreal injection |
|
|
| Baseline, Month 12 |
| Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study | Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center. A patient was considered to have developed new GA if they did not have any GA at the start of the study period and were subsequently diagnosed with GA during the study period (diagnosis of GA change from "No" to "Yes)." The analysis of new GA development was restricted to only those subjects without GA reported at baseline. One eye (study eye) contributed to the analysis. | Baseline, Month 12, Month 24 |
| Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24 | The number of intravitreal injections was calculated. One eye (study eye) contributed to the analysis. | Baseline, Month 12, Month 24 |
| Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24 | Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. BCVA change was defined as a change in letters correctly identified from the baseline assessment. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis | Baseline, Month 12, Month 24 |
| Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24 | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis | Baseline, Month 12, Month 24 |
| Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF) | Intraretinal fluid and subretinal fluid was assessed using Optical Coherence Tomography (OCT) and recorded as Present/Absent. One eye (study eye) contributed to the analysis. | Month 2, Month 12, Month 24 |
| Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24 | Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis. | Baseline, Month 12, Month 24 |
| Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24 | Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis. | Baseline, Month 12, Month 24 |
| Mean Number of Times a Patient Needed to Return to Monthly Intravitreal Injections Over 24 Months | The number of times the patient returned to a monthly injection interval (from an extended interval) at least once during the 24-month study was calculated. One eye (study eye) contributed to the analysis. | Month 24 |
| Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment | Blood for VEGF plasma concentration analysis was collected at Baseline and again at 7 days after the injection at Week 4 and 7 days after the injection at Week 8. | Baseline, Week 5, Week 9 |
| Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24 | Retinal nerve fibre thickness was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change in value (i.e. thinner nerve fibre) indicates nerve damage. One eye (study eye) contributed to the analysis. | Baseline, Month 12, Month 24 |
| Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells | Anterior cell grade was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. One eye (study eye) contributed to the analysis. | Baseline, Week 9 |
| Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare | Anterior chamber flare was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. Proportion of patients is reported as a percentage. One eye (study eye) contributed to the analysis. | Baseline, Week 9 |
| Brookvale |
| New South Wales |
| 2100 |
| Australia |
| Novartis Investigative Site | Chatswood | New South Wales | 2067 | Australia |
| Novartis Investigative Site | Hurtsville | New South Wales | 2220 | Australia |
| Novartis Investigative Site | Mona Vale | New South Wales | Australia |
| Novartis Investigative Site | Parramatta | New South Wales | 2150 | Australia |
| Novartis Investigative Site | Strathfield | New South Wales | 2035 | Australia |
| Novartis Investigative Site | Strathfield | New South Wales | 2135 | Australia |
| Novartis Investigative Site | Sydney | New South Wales | 2000 | Australia |
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia |
| Novartis Investigative Site | Sydney | NSW 2000 | AUSTRALIA | Australia |
| Novartis Investigative Site | Caboolture | Queensland | 4510 | Australia |
| Novartis Investigative Site | Redcliffe | Queensland | 4020 | Australia |
| Novartis Investigative Site | South Brisbane | Queensland | 4101 | Australia |
| Novartis Investigative Site | Southport | Queensland | 4215 | Australia |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | South Launceston | Tasmania | 7249 | Australia |
| Novartis Investigative Site | Clayton | Victoria | 3168 | Australia |
| Novartis Investigative Site | Malvern | Victoria | 3144 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3065 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Subiaco | Western Australia | 6008 | Australia |
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
| Safety Set |
|
| Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients randomized to treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.5 mg | 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend] |
| BG001 | Aflibercept 2.0 mg | 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend] |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Predominant race | Number | participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24 | Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis. | All randomized patients with at least one post-baseline efficacy value for the primary endpoint (FAS). Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Mean | Standard Deviation | mm | Baseline, Month 24 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12 | Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis. | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Mean | Standard Deviation | mm | Baseline, Month 12 |
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| Secondary | Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study | Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center. A patient was considered to have developed new GA if they did not have any GA at the start of the study period and were subsequently diagnosed with GA during the study period (diagnosis of GA change from "No" to "Yes)." The analysis of new GA development was restricted to only those subjects without GA reported at baseline. One eye (study eye) contributed to the analysis. | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Number | percentage of patients | Baseline, Month 12, Month 24 |
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| Secondary | Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24 | The number of intravitreal injections was calculated. One eye (study eye) contributed to the analysis. | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Mean | Standard Deviation | injections | Baseline, Month 12, Month 24 |
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| Secondary | Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24 | Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. BCVA change was defined as a change in letters correctly identified from the baseline assessment. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Mean | Standard Deviation | letters | Baseline, Month 12, Month 24 |
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| Secondary | Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24 | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Mean | Standard Deviation | micrometers | Baseline, Month 12, Month 24 |
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| Secondary | Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF) | Intraretinal fluid and subretinal fluid was assessed using Optical Coherence Tomography (OCT) and recorded as Present/Absent. One eye (study eye) contributed to the analysis. | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Number | percentage of patients | Month 2, Month 12, Month 24 |
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| Secondary | Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24 | Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis. | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Number | percentage of patients | Baseline, Month 12, Month 24 |
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| Secondary | Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24 | Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis. | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Number | percentage of patients | Baseline, Month 12, Month 24 |
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| Secondary | Mean Number of Times a Patient Needed to Return to Monthly Intravitreal Injections Over 24 Months | The number of times the patient returned to a monthly injection interval (from an extended interval) at least once during the 24-month study was calculated. One eye (study eye) contributed to the analysis. | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. Descriptive statistics only. | Posted | Mean | Standard Deviation | occurrences | Month 24 |
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| Secondary | Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment | Blood for VEGF plasma concentration analysis was collected at Baseline and again at 7 days after the injection at Week 4 and 7 days after the injection at Week 8. | FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. | Posted | Mean | Standard Deviation | picogram/milliliter (pg/mL) | Baseline, Week 5, Week 9 |
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| Secondary | Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24 | Retinal nerve fibre thickness was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change in value (i.e. thinner nerve fibre) indicates nerve damage. One eye (study eye) contributed to the analysis. | Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only. | Posted | Number | percentage of patients | Baseline, Month 12, Month 24 |
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| Secondary | Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells | Anterior cell grade was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. One eye (study eye) contributed to the analysis. | Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only. | Posted | Number | percentage of patients | Baseline, Week 9 |
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| Secondary | Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare | Anterior chamber flare was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. Proportion of patients is reported as a percentage. One eye (study eye) contributed to the analysis. | Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only. | Posted | Number | percentage of patients | Baseline, Week 9 |
|
Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
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 | Ranibizumab 0.5 mg | 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend] | 3 | 141 | 50 | 141 | 122 | 141 |
| EG001 | Aflibercept 2.0 mg | 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend] | 6 | 139 | 58 | 139 | 123 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia (Non-ocular) | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Iron deficiency anaemia (Non-ocular) | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Platelet dysfunction (Non-ocular) | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute myocardial infarction (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Aortic valve incompetence (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Atrial fibrillation (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Atrioventricular block complete (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac arrest (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac failure (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac failure chronic (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac failure congestive (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Coronary artery disease (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Left ventricular failure (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myocardial infarction (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Palpitations (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tachycardia (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ventricular tachycardia (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Meniere's disease (Non-ocular) | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Retinal artery embolism (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Retinal artery occlusion (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Retinal detachment (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diverticulum (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastritis (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Intestinal obstruction (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Localised intraabdominal fluid collection (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oesophageal food impaction (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Peritoneal adhesions (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pharyngo-oesophageal diverticulum (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rectal haemorrhage (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Small intestinal obstruction (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Volvulus (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest pain (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Condition aggravated (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Death (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Disease progression (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| General physical health deterioration (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hernia (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bile duct stone (Non-ocular) | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholecystitis (Non-ocular) | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Blastocystis infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cellulitis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Clostridium difficile colitis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cystitis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Endophthalmitis (Left eye) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Endophthalmitis (Right eye) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Escherichia infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gallbladder empyema (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis viral (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Herpes zoster (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Localised infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Lower respiratory tract infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Onychomycosis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia bacterial (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Rhinovirus infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sepsis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Septic shock (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Subcutaneous abscess (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection bacterial (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Ankle fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Back injury (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Cataract traumatic (Right eye) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Contusion (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Facial bones fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Fall (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Femoral neck fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Femur fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Fibula fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Foot fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Forearm fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hip fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Humerus fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Jaw fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Joint injury (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Laceration (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Limb injury (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Radius fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Rib fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Spinal column injury (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Subdural haematoma (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Subdural haemorrhage (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Tibia fracture (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hypercalcaemia (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoglycaemia (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyponatraemia (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Malnutrition (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Metabolic acidosis (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arthritis (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Intervertebral disc space narrowing (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Mobility decreased (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscular weakness (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Osteoarthritis (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Spinal column stenosis (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Adrenal gland cancer (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Angioimmunoblastic T-cell lymphoma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Basal cell carcinoma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Benign ovarian tumour (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Benign uterine neoplasm (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Bladder cancer (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Bladder cancer recurrent (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Bladder neoplasm (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrointestinal carcinoma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Malignant melanoma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Malignant neoplasm progression (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Mesothelioma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Myeloproliferative disorder (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Oesophageal cancer metastatic (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Pancreatic carcinoma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Prostate cancer (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Sinonasal papilloma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Small cell lung cancer metastatic (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Squamous cell carcinoma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Tonsil cancer (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Amnesia (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Aphasia (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Basal ganglia haemorrhage (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral artery thrombosis (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebrovascular accident (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dementia (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysarthria (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ischaemic stroke (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lacunar infarction (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neuralgia (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Presyncope (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Subarachnoid haemorrhage (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Syncope (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Transient ischaemic attack (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Delirium (Non-ocular) | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depression (Non-ocular) | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haematuria (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nephrolithiasis (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Obstructive uropathy (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal failure acute (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urethral haemorrhage (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary bladder haemorrhage (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary retention (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ovarian cyst (Non-ocular) | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Prostatomegaly (Non-ocular) | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Uterovaginal prolapse (Non-ocular) | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginal ulceration (Non-ocular) | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Epistaxis (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pleural effusion (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary embolism (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary hypertension (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary oedema (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Respiratory failure (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Open reduction of fracture (Non-ocular) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Aortic dilatation (Non-ocular) | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Aortic embolus (Non-ocular) | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Aortic stenosis (Non-ocular) | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertension (Non-ocular) | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypotension (Non-ocular) | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia (Non-ocular) | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Angina pectoris (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Atrial fibrillation (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bundle branch block left (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tachycardia (Non-ocular) | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vertigo (Non-ocular) | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Age-related macular degeneration (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Age-related macular degeneration (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Blepharitis (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cataract (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cataract (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cataract (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chalazion (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chalazion (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Choroidal neovascularisation (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Choroidal neovascularisation (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dry eye (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dry eye (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye discharge (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye discharge (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye discharge (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye irritation (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye irritation (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye irritation (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye pain (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye pain (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye pain (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye pruritus (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lacrimation increased (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lacrimation increased (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lacrimation increased (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Macular degeneration (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Metamorphopsia (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Metamorphopsia (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ocular hyperaemia (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ocular hyperaemia (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Posterior capsule opacification (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Retinal haemorrhage (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Retinal haemorrhage (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Retinal pigment epithelial tear (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vision blurred (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vision blurred (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vision blurred (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Visual acuity reduced (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitreous detachment (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitreous detachment (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitreous detachment (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitreous floaters (Both eyes) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitreous floaters (Left eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitreous floaters (Right eye) | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting (Non-ocular) | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthenia (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest pain (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza like illness (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Malaise (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema peripheral (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain (Right eye) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia (Non-ocular) | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Drug hypersensitivity (Both eyes) | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Drug hypersensitivity (Non-ocular) | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Seasonal allergy (Non-ocular) | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cellulitis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Diverticulitis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Herpes zoster (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Lower respiratory tract infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sinusitis (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection (Non-ocular) | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Contusion (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Corneal abrasion (Right eye) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Fall (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Head injury (Non-ocular) | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal X-ray (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Angiogram (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Arteriogram coronary (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Biopsy (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood chloride decreased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood cholesterol increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood creatinine increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood sodium decreased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood urea increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| C-reactive protein increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Chest X-ray (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Colonoscopy (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Computerised tomogram (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Computerised tomogram abdomen (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Computerised tomogram head (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Cystoscopy (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Echocardiogram (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Electrocardiogram (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Electrocardiogram ambulatory (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Full blood count (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Glomerular filtration rate decreased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Haematocrit decreased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Haemoglobin decreased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| International normalised ratio increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Intraocular pressure increased (Left eye) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Lymphocyte count decreased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Neutrophil count increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Nuclear magnetic resonance imaging (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Nuclear magnetic resonance imaging brain (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Red blood cell count decreased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Ultrasound Doppler (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Ultrasound abdomen (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Ultrasound kidney (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Weight decreased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| White blood cell count increased (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| X-ray (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| X-ray limb (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| X-ray of pelvis and hip (Non-ocular) | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Hypercholesterolaemia (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitamin D deficiency (Non-ocular) | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arthralgia (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arthritis (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscular weakness (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Musculoskeletal pain (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Osteoarthritis (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Osteoporosis (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain in extremity (Non-ocular) | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lethargy (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Migraine (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neuralgia (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sciatica (Non-ocular) | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anxiety (Non-ocular) | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Delirium (Non-ocular) | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia (Non-ocular) | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haematuria (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal cyst (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal impairment (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary incontinence (Non-ocular) | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthma (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cough (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oropharyngeal pain (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Productive cough (Non-ocular) | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash (Non-ocular) | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Skin lesion (Non-ocular) | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cancer surgery (Non-ocular) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac pacemaker insertion (Non-ocular) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Cataract operation (Left eye) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Cataract operation (Right eye) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Hip arthroplasty (Non-ocular) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Inguinal hernia repair (Non-ocular) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Intraocular lens implant (Right eye) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Radiotherapy (Non-ocular) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Skin neoplasm excision (Non-ocular) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Transfusion (Non-ocular) | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertension (Non-ocular) | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypotension (Non-ocular) | Vascular disorders | MedDRA (17.0) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2018 | Oct 23, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Black African |
|
| Asian |
|
| Other |
|
| Change from Baseline at Month 24 |
|
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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