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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000120-33 | EudraCT Number |
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To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)
330 Patients who have completed at least one year of treatment with aflibercept will be randomized to two different aflibercept regimens and followed for 76 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept extended dosing | Experimental | Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed). |
|
| Aflibercept 2Q8 (2 mg aflibercept administered every 8 weeks) | Active Comparator | Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | A dose of 2 mg aflibercept injected intravitreally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye | Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function. | From baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Vision in the Study Eye | A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline. | At week 52 |
| Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye |
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Inclusion Criteria:
The following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment at least 1 year before this study):
Men and women >= 51 years of age
The subject's history of aflibercept treatment meets ALL of the following:
Exclusion Criteria:
- Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye other than aflibercept.
Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (FA) in the study eye
Subretinal hemorrhage that was:
Scar or fibrosis making up more than 50% of the total lesion in the study eye.
Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
Causes of CNV other than AMD in the study eye.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | 1090 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38183525 | Derived | Kodjikian L, Arias Barquet L, Papp A, Kertes PJ, Midena E, Ernest J, Silva R, Schmelter T, Niesen T, Leal S. Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration Beyond One Year of Treatment: AZURE, a Randomized Trial of Treat-and-Extend vs. Fixed Dosing. Adv Ther. 2024 Mar;41(3):1010-1024. doi: 10.1007/s12325-023-02719-3. Epub 2024 Jan 6. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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At baseline, 336 participants were randomized to one of 2 treatment groups; 168 participants were randomized to the extended-dosing group and 168 participants were randomized to the 2Q8 (2 mg aflibercept administered every 8 weeks) group.
Study was conducted at 76 centers in 14 countries or regions, between 29-SEP-2015 (first participant first visit) and 04-JUN-2020 (last participant last visit)
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| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept Extended Dosing | Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed). |
| 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 | Dec 10, 2015 | Feb 5, 2021 |
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| At week 52 |
| Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Retinal characteristic was evaluated using Optical coherence tomography (OCT). | From baseline to week 52 |
| Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye | Choroidal neovascularization measured by optical coherence tomography (OCT). | From baseline to week 52 |
| Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye | At week 52 |
| Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire | National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst. | From baseline to week 52 |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Started after the first application of aflibercept in the study and less than or equal to 30 days after the last dose of study drug over approximately 1.5 years |
| Vienna |
| 1140 |
| Austria |
| Toronto | Ontario | M4N 3M5 | Canada |
| Clinique medicale de l'oeil de l'Estrie | Sherbrooke | Quebec | J1J 2B8 | Canada |
| Hradec Králové | 500 05 | Czechia |
| Pilsen | 304 60 | Czechia |
| Prague | 100 34 | Czechia |
| Prague | 12808 | Czechia |
| Prague | 150 00 | Czechia |
| Paris | Cedex 12 | 75557 | France |
| Bordeaux | 33000 | France |
| Dijon | BP 1542-21 | France |
| Lyon | 69317 | France |
| Nice | 06006 | France |
| Paris | 75010 | France |
| Würzburg | Bavaria | 97080 | Germany |
| Darmstadt | Hesse | 64297 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Marburg | Hesse | 35037 | Germany |
| Göttingen | Lower Saxony | 37075 | Germany |
| Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Berlin | 10713 | Germany |
| Berlin | 12203 | Germany |
| Hamburg | 20251 | Germany |
| Budapest | 1085 | Hungary |
| Debrecen | 4032 | Hungary |
| Pécs | 7621 | Hungary |
| Rome | Lazio | 00133 | Italy |
| Rome | Lazio | 00198 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Brescia | Lombardy | 25015 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Milan | Lombardy | 20157 | Italy |
| Turin | Piedmont | 10122 | Italy |
| Catania | Sicily | 95123 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Verona | Veneto | 37134 | Italy |
| Parma | 43126 | Italy |
| Kaunas | LT-50009 | Lithuania |
| Vilnius | LT-08661 | Lithuania |
| Gdansk | 80-809 | Poland |
| Olsztyn | 10-424 | Poland |
| Coimbra | 3000-548 | Portugal |
| Leiria | 2410-197 | Portugal |
| Lisbon | 1649-035 | Portugal |
| Porto | 4200-319 | Portugal |
| Bratislava | 826 06 | Slovakia |
| Bratislava | 851 07 | Slovakia |
| Nitra | 949 01 | Slovakia |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Barcelona | 08036 | Spain |
| Valencia | 46014 | Spain |
| Bern | Switzerland |
| Geneva | 1204 | Switzerland |
| Southampton | Hampshire | SO16 6YD | United Kingdom |
| Liverpool | Merseyside | L7 8XP | United Kingdom |
| Great Yarmouth | Norfolk | NR31 6LA | United Kingdom |
| Middlesbrough | North Yorkshire | TS4 3BW | United Kingdom |
| Pont-y-clun | Rhondda, Cynon, Taff | CF72 8XR | United Kingdom |
| Guildford | Surrey | GU2 7XX | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |
| Sunderland | Tyne and Wear | SR2 9HP | United Kingdom |
| Rugby | Warwickshire | CV22 5PX | United Kingdom |
| Wakefield | West Yorkshire | WF1 4DG | United Kingdom |
| Hull | York | HU3 2JZ | United Kingdom |
| Colchester | CO3 3NB | United Kingdom |
| London | NW1 5QH | United Kingdom |
| London | SE5 9RS | United Kingdom |
| Manchester | M13 9WL | United Kingdom |
| FG001 | Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks) | Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed. |
| Treated |
|
| Post-baseline BCVA Assessment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety analysis set (SAF): included all participants who received any study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept Extended Dosing | Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed). |
| BG001 | Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks) | Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed. |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual | Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function. | The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment. | Mean | Standard Deviation | Letters read correctly |
| |||||||||||||
| Central retinal thickness (CRT) in the study eye | Retinal characteristic was evaluated using Optical coherence tomography (OCT). | The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment. | Mean | Standard Deviation | μm |
| |||||||||||||
| Choroidal neovascularization (CNV) area in the study eye | Choroidal neovascularization measured by optical coherence tomography (OCT). | The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment. | Mean | Standard Deviation | mm*2 |
| |||||||||||||
| Total score for National Eye Institute 25-Item Visual Function | National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst. | The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment. | Mean | Standard Deviation | Score on a scale |
|
| 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 Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye | Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function. | The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment. | Posted | Mean | Standard Deviation | Letters read correctly | From baseline to Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Vision in the Study Eye | A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline. | The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment. | Posted | Number | Percentage of participants | At week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye | The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment. | Posted | Number | Percentage of participants | At week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Retinal characteristic was evaluated using Optical coherence tomography (OCT). | The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point. | Posted | Mean | Standard Deviation | μm | From baseline to week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye | Choroidal neovascularization measured by optical coherence tomography (OCT). | The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point. | Posted | Mean | Standard Deviation | mm*2 | From baseline to week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye | The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment. | Posted | Number | Percentage of participants | At week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire | National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst. | The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point. | Posted | Mean | Standard Deviation | Score on a scale | From baseline to week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Number of participants with TEAE was analyzed based on safety analysis set (SAF) with number of participants evaluable. | Posted | Count of Participants | Participants | Started after the first application of aflibercept in the study and less than or equal to 30 days after the last dose of study drug over approximately 1.5 years |
|
|
From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept Extended Dosing | Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed). | 0 | 167 | 26 | 167 | 60 | 167 |
| EG001 | Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks) | Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed. | 3 | 168 | 23 | 168 | 70 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastrointestinal vascular malformation haemorrhagic | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cataract operation complication | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral arterial reocclusion | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Oesophageal prosthesis insertion | Surgical and medical procedures | MedDRA (23.0) | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Choroidal neovascularisation | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Subretinal fluid | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2020 | Dec 18, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
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