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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Aflibercept Injection 2Q4 | Experimental | Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks. |
|
| Intravitreal Aflibercept Injection 2Q8 | Experimental | Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks. |
|
| Macular Laser Photocoagulation | Active Comparator | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Biological | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) | Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment. | Baseline up to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning. | Baseline up to week 52 |
| Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | 510064 | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32210527 | Derived | Chen YX, Li XX, Yoon YH, Sun X, Astakhov Y, Xu G, Wang H, Ren X, Asmus F; VIVID-East investigators. Intravitreal Aflibercept versus Laser Photocoagulation in Asian Patients with Diabetic Macular Edema: The VIVID-East Study. Clin Ophthalmol. 2020 Mar 9;14:741-750. doi: 10.2147/OPTH.S235267. eCollection 2020. | |
| 31904267 | Derived |
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Overall 539 participants were screened, of them 381 participants were randomized, and 378 participants were allocated to treatment.
The study was conducted at centers in China, Hong Kong, South Korea, and Russian Federation between 18 February 2013 (first participant first visit) and 09 March 2015 (last participant last visit) (data cut-off date).
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravitreal Aflibercept Injection 2Q4 | Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks. |
| FG001 | Intravitreal Aflibercept Injection 2Q8 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Biological | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8). |
|
| Macular Laser Photocoagulation | Procedure | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. |
|
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning. |
| Baseline up to week 52 |
| Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF | ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85) | Baseline up to week 52 |
| Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF | CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. | Baseline up to week 52 |
| Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. | Baseline up to week 52 |
| Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. | Baseline up to week 52 |
| Wuhan |
| Hubei |
| 430040 |
| China |
| Changsha | Hunan | 410011 | China |
| Shenyang | Liaoning | 110034 | China |
| Xi'an | Shaanxi | 710032 | China |
| Qingdao | Shandong | China |
| Chengdu | Sichuan | 610041 | China |
| Hangzhou | Zhejiang | 310009 | China |
| Wenzhou | Zhejiang | China |
| Beijing | 100044 | China |
| Beijing | 100050 | China |
| Beijing | 100083 | China |
| Beijing | 100730 | China |
| Beijing | 2000080 | China |
| Chongqing | 400042 | China |
| Shanghai | China |
| Tianjin | China |
| Hong Kong | Hong Kong |
| Kowloon | Hong Kong |
| Moscow | 105062 | Russia |
| Moscow | 127486 | Russia |
| Novosibirsk | 630071 | Russia |
| Saint Petersburg | 197022 | Russia |
| Seoul | 135-710 | South Korea |
| Seoul | 138-736 | South Korea |
| Ming J, Zhang Y, Xu X, Zhao M, Wang Y, Chen Y, Zhang F, Wang J, Liu J, Zhao X, Han R, Hu S. Cost-effectiveness analysis of intravitreal aflibercept in the treatment of diabetic macular edema in China. J Comp Eff Res. 2020 Feb;9(3):161-175. doi: 10.2217/cer-2019-0174. Epub 2020 Jan 6. |
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks. |
| FG002 | Macular Laser Photocoagulation | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks. |
| Participants Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intravitreal Aflibercept Injection 2Q4 | Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) 2Q4 over 48 weeks. |
| BG001 | Intravitreal Aflibercept Injection 2Q8 | Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks. |
| BG002 | Macular Laser Photocoagulation | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks. |
| BG003 | 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 |
| ||||||||||||||||
| Region of Enrollment | Geographic region | 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 | Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) | Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment. | Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA. FAS with assessment for this outcome measure. | Posted | Mean | Standard Deviation | Letters correctly read | Baseline up to week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning. | FAS. | Posted | Number | Percentage of participants | Baseline up to week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning. | FAS. | Posted | Number | Percentage of participants | Baseline up to week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF | ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85) | FAS. | Posted | Number | Percentage of participants | Baseline up to week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF | CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. | FAS with assessment for this outcome measure. | Posted | Mean | Standard Deviation | micrometer | Baseline up to week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. | FAS with assessment for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline up to week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. | FAS with assessment for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline up to week 52 |
|
From the start of study treatment up to 52 weeks
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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 | Intravitreal Aflibercept Injection 2Q4 | Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks. | 19 | 127 | 87 | 127 | ||
| EG001 | Intravitreal Aflibercept Injection 2Q8 | Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks. | 22 | 127 | 83 | 127 | ||
| EG002 | Macular Laser Photocoagulation | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks. | 24 | 124 | 89 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Right ventricular hypertrophy | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyphaema | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Renal osteodystrophy | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Malignant lymphoid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetic retinal oedema | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Retinal aneurysm | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Visual acuity tests abnormal | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Male |
|
| Russia |
|
| Other Asia-Pacific (Hong Kong, Korea) |
|
| <0.0001 |
| Mean Difference (Final Values) |
| 13.6 |
| 2-Sided |
| 97.5 |
| 10.2 |
| 16.9 |
LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. |
| No |
| Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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