DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection... | NCT00789477

NCT00789477

Status Module

Sponsor/Collaborators Module

Name	Class
Bayer	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravitreal Aflibercept Injection .5Q4	Experimental	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks	Drug: Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2Q4	Experimental	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks	Drug: Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2Q8	Experimental	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks	Drug: Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2PRN	Experimental	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria	Drug: Intravitreal Aflibercept Injection
Laser Photocoagulation	Active Comparator	Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.

Name	Type	Description	Arm Group Labels	Other Names
Laser Photocoagulation	Procedure	laser every 16 weeks as needed	Laser Photocoagulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).	At week 24

Secondary Outcomes

Measure	Description	Time Frame
Change in BCVA From Baseline to Week 52 - LOCF	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).	At week 52

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Artesia	California	90701	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Laser Photocoagulation	Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
FG001	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

macular laser therapy

FG00044 subjectsrandomized

FG00144 subjectsrandomized

FG00244 subjectsrandomized

FG00344 subjectsrandomized

FG00445 subjectsrandomized

Full analysis set (FAS): included all randomized patients who received any study drug, had baseline assessments, and had at least one (1) post-baseline assessment.

Arm/Group Information

ID	Title	Description
BG000	Laser Photocoagulation	Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
BG001	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4	Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
BG002	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
BG003	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
BG004	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0002.5± 16.14 OG0018.6± 14.64 OG00211.4± 8.67 OG003

Secondary

Change in BCVA From Baseline to Week 52 - LOCF

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

FAS

Posted

Mean

Standard Deviation

letters correctly read

At week 52

ID	Title	Description
OG000	Laser Photocoagulation	Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
OG001	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4	Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
OG002	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
OG003	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8

Secondary

Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF

Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

FAS

Posted

Number

participants

At week 24 and week 52

ID	Title	Description
OG000	Laser Photocoagulation	Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
OG001	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4	Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
OG002	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
OG003	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52

Secondary

Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF

Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

microns

At week 24 and week 52

ID	Title	Description
OG000	Laser Photocoagulation	Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
OG001	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4	Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
OG002	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
OG003	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8

Secondary

Number of Focal Laser Treatments

For the first 24 weeks, the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups did not receive laser treatment. From week 24 onward, participants in the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups were allowed to receive laser rescue treatment.

Posted

Mean

Standard Deviation

Treatments

Week 1 to week 48

ID	Title	Description
OG000	Laser Photocoagulation	Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
OG001	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4	Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
OG002	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
OG003	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Laser Photocoagulation	Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.	10	44	20	44
EG001	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4	Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52	14	44	22	44
EG002	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52	13	44	22	44
EG003	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52	12	42	26	42
EG004	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN	Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52	6	45	24	45

Serious Adverse Events

Term	Organ System	Source Vocabulary	Notes	Statistical Information
Abscess	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG0030 affected42 at risk EG0040 affected45 at risk
Abscess limb	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0022 affected44 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Angle closure glaucoma	Eye disorders	MedDRA 13.1	Study eye	EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Appendicitis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Blood pressure increased	Investigations	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0023 affected44 at risk EG003
Cellulitis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0013 affected44 at risk EG0022 affected44 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 13.1		EG0001 affected44 at risk EG0011 affected44 at risk EG0022 affected44 at risk EG003
Chest pain	General disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0022 affected44 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Colon cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Convulsion	Nervous system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Corneal abrasion	Eye disorders	MedDRA 13.1	Study eye	EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Cystitis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Cystoid macular oedema	Eye disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Device occlusion	General disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Diabetic retinal oedema	Eye disorders	MedDRA 13.1	Study eye	EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Endophthalmitis	Infections and infestations	MedDRA 13.1	Study eye	EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Gangrene	Infections and infestations	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0022 affected44 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0022 affected44 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1		EG0001 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Hypotension	Vascular disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Joint capsule rupture	Injury, poisoning and procedural complications	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Liver function test abnormal	Investigations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Localised infection	Infections and infestations	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Maculopathy	Eye disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Multi-organ failure	General disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0012 affected44 at risk EG0020 affected44 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Nephropathy	Renal and urinary disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Parotitis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Pneumonia	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Pyrexia	General disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Renal cell carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Retinal tear	Eye disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Sciatica	Nervous system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Sepsis	Infections and infestations	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Silent myocardial infarction	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Sudden death	General disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Syncope	Nervous system disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Uveitis	Eye disorders	MedDRA 13.1	Study eye	EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 13.1	Study eye	EG0001 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Vitreous adhesions	Eye disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 13.1	Study eye	EG0003 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 13.1		EG0001 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0021 affected44 at risk EG003
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1		EG0002 affected44 at risk EG0011 affected44 at risk EG0023 affected44 at risk EG0034 affected42 at risk EG0045 affected45 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0020 affected44 at risk EG003
Blepharitis	Eye disorders	MedDRA 13.1		EG0000 affected44 at risk EG0010 affected44 at risk EG0024 affected44 at risk EG003
Blepharitis	Eye disorders	MedDRA 13.1	Study eye	EG0000 affected44 at risk EG0010 affected44 at risk EG0024 affected44 at risk EG003
Blood glucose increased	Investigations	MedDRA 13.1		EG0001 affected44 at risk EG0014 affected44 at risk EG0023 affected44 at risk EG003
Blood potassium increased	Investigations	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Blood pressure increased	Investigations	MedDRA 13.1		EG0001 affected44 at risk EG0011 affected44 at risk EG0024 affected44 at risk EG003
Blood urine present	Investigations	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.1		EG0001 affected44 at risk EG0013 affected44 at risk EG0022 affected44 at risk EG003
Cataract	Eye disorders	MedDRA 13.1		EG0001 affected44 at risk EG0012 affected44 at risk EG0021 affected44 at risk EG003
Cataract	Eye disorders	MedDRA 13.1	Study eye	EG0002 affected44 at risk EG0012 affected44 at risk EG0023 affected44 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 13.1		EG0008 affected44 at risk EG00112 affected44 at risk EG0027 affected44 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 13.1	Study eye	EG0000 affected44 at risk EG0010 affected44 at risk EG0022 affected44 at risk EG003
Diabetic retinal oedema	Eye disorders	MedDRA 13.1		EG0000 affected44 at risk EG0014 affected44 at risk EG0023 affected44 at risk EG003
Diabetic retinal oedema	Eye disorders	MedDRA 13.1	Study eye	EG0000 affected44 at risk EG0011 affected44 at risk EG0023 affected44 at risk EG003
Eye pain	Eye disorders	MedDRA 13.1		EG0003 affected44 at risk EG0012 affected44 at risk EG0020 affected44 at risk EG003
Eye pain	Eye disorders	MedDRA 13.1	Study eye	EG0002 affected44 at risk EG0016 affected44 at risk EG0025 affected44 at risk EG003
Foreign body sensation in eye	Eye disorders	MedDRA 13.1	Study eye	EG0000 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Glucose urine present	Investigations	MedDRA 13.1		EG0001 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA 13.1		EG0002 affected44 at risk EG0016 affected44 at risk EG0025 affected44 at risk EG003
Haematocrit decreased	Investigations	MedDRA 13.1		EG0002 affected44 at risk EG0012 affected44 at risk EG0024 affected44 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 13.1		EG0002 affected44 at risk EG0012 affected44 at risk EG0023 affected44 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1		EG0002 affected44 at risk EG0010 affected44 at risk EG0022 affected44 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 13.1		EG0001 affected44 at risk EG0011 affected44 at risk EG0023 affected44 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.1		EG0005 affected44 at risk EG0015 affected44 at risk EG0025 affected44 at risk EG003
Intraocular pressure increased	Investigations	MedDRA 13.1	Study eye	EG0001 affected44 at risk EG0016 affected44 at risk EG0026 affected44 at risk EG003
Macular oedema	Eye disorders	MedDRA 13.1		EG0003 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Maculopathy	Eye disorders	MedDRA 13.1	Study eye	EG0002 affected44 at risk EG0012 affected44 at risk EG0021 affected44 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 13.1		EG0004 affected44 at risk EG0014 affected44 at risk EG0023 affected44 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1		EG0001 affected44 at risk EG0012 affected44 at risk EG0023 affected44 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 13.1	Study eye	EG0002 affected44 at risk EG0015 affected44 at risk EG0022 affected44 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.1		EG0003 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1		EG0003 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Posterior capsule opacification	Eye disorders	MedDRA 13.1		EG0003 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Protein urine present	Investigations	MedDRA 13.1		EG0002 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Punctate keratitis	Eye disorders	MedDRA 13.1	Study eye	EG0001 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Red blood cell count decreased	Investigations	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0023 affected44 at risk EG003
Retinal aneurysm	Eye disorders	MedDRA 13.1		EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected44 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 13.1		EG0003 affected44 at risk EG0011 affected44 at risk EG0021 affected44 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 13.1	Study eye	EG0002 affected44 at risk EG0010 affected44 at risk EG0023 affected44 at risk EG003
Retinal aneurysm	Eye disorders	MedDRA 13.1	Study eye	EG0001 affected44 at risk EG0013 affected44 at risk EG0020 affected44 at risk EG003
Retinal neovascularisation	Eye disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0022 affected44 at risk EG003
Retinal exudates	Eye disorders	MedDRA 13.1	Study eye	EG0001 affected44 at risk EG0014 affected44 at risk EG0021 affected44 at risk EG003
Vision blurred	Eye disorders	MedDRA 13.1	Study eye	EG0001 affected44 at risk EG0014 affected44 at risk EG0020 affected44 at risk EG003
Vitreous detachment	Eye disorders	MedDRA 13.1		EG0003 affected44 at risk EG0012 affected44 at risk EG0021 affected44 at risk EG003
Vitreous detachment	Eye disorders	MedDRA 13.1	Study eye	EG0005 affected44 at risk EG0013 affected44 at risk EG0023 affected44 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 13.1		EG0001 affected44 at risk EG0010 affected44 at risk EG0023 affected44 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 13.1	Study eye	EG0002 affected44 at risk EG0015 affected44 at risk EG0023 affected44 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 13.1		EG0005 affected44 at risk EG0013 affected44 at risk EG0025 affected44 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 13.1	Study eye	EG0005 affected44 at risk EG0010 affected44 at risk EG0022 affected44 at risk EG003

ID	Term
C533178	aflibercept

Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52

EG0040 affected45 at risk

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EG0042 affected45 at risk

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EG0040 affected45 at risk

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EG0040 affected45 at risk

EG0041 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

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EG0041 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

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EG0041 affected45 at risk

EG0043 affected45 at risk

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EG00413 affected45 at risk

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EG0043 affected45 at risk

EG0040 affected45 at risk

EG0047 affected45 at risk

EG0043 affected45 at risk

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EG0042 affected45 at risk

EG0040 affected45 at risk

EG0042 affected45 at risk

EG0041 affected45 at risk

EG0045 affected45 at risk

EG0042 affected45 at risk

EG0040 affected45 at risk

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EG0043 affected45 at risk

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EG0040 affected45 at risk

EG0043 affected45 at risk

EG0040 affected45 at risk

EG0041 affected45 at risk

EG0045 affected45 at risk