A Phase 3 Safety and Efficacy Study of Fovista® (E10030)... | NCT01940900

NCT01940900

Status Module

Oversight Module

Description 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
E10030 + ranibizumab	Experimental	E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection	Drug: E10030 Drug: ranibizumab
Sham + ranibizumab	Active Comparator	E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection	Drug: ranibizumab Drug: E10030 sham intravitreal injection

Name	Type	Description	Arm Group Labels	Other Names
E10030	Drug		E10030 + ranibizumab	Fovista®
ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in Visual Acuity From Baseline to 12 Months	The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.	12 Months

Eligibility Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30957581	Derived	Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	E10030 + Ranibizumab	E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection E10030 ranibizumab
FG001	Sham + Ranibizumab	E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection ranibizumab E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	E10030 + Ranibizumab	E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection E10030 ranibizumab
BG001	Sham + Ranibizumab	E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection ranibizumab E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle
BG002	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, Customized

Count of Participants

Participants

Title

Denominators

Categories

Age

Title	Measurements
Adults 18-64 years	BG00030 BG00131 BG00261
Adults 65-84 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000178 BG001189 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Colombia

Title	Measurements
	BG00011 BG0019 BG002

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 Visual Acuity From Baseline to 12 Months

The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.

Mean change in visual acuity (ETDRS letter) from Baseline to Month 12

Posted

Mean

Standard Error

letters

12 Months

ID	Title	Description
OG000	E10030 + Ranibizumab	E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection E10030 ranibizumab
OG001	Sham + Ranibizumab	E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection ranibizumab E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle

Units	Counts
Participants	OG000311 OG001315

Title

Denominators

Categories

Title	Measurements
	OG0009.91± 0.88 OG00110.36± 0.87

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	E10030 + Ranibizumab	E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection E10030 ranibizumab	4	312	56	312	161	312
EG001	Sham + Ranibizumab	E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection ranibizumab E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle	4	314	49	314	136	314

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Accelerated hypertension	Vascular disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Hypertension	Vascular disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Hypertensive crisis	Vascular disorders	MedDR 18.1	Non-systematic Assessment	EG0002 events2 affected312 at risk EG0010 events0 affected314 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Follicle centre, lymphoma, follicular grade I, II, III stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Lung carcinoma cell type unspecified stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0003 events2 affected312 at risk EG0013 events3 affected314 at risk
Lung squamous cell carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0002 events1 affected312 at risk EG0010 events0 affected314 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0003 events3 affected312 at risk EG0010 events0 affected314 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0002 events1 affected312 at risk EG0010 events0 affected314 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0002 events1 affected312 at risk EG0010 events0 affected314 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0002 events1 affected312 at risk EG0010 events0 affected314 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0012 events2 affected314 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Malignant melanoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Asthenia	General disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Chest pain	General disorders	MedDR 18.1	Non-systematic Assessment	EG0003 events1 affected312 at risk EG0010 events0 affected314 at risk
Device malfunction	General disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Cataract traumatic	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Fall	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0003 events3 affected312 at risk EG0012 events2 affected314 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0013 events3 affected314 at risk
Limb injury	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0011 events1 affected314 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0011 events1 affected314 at risk
Atrial fibrillation	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0004 events3 affected312 at risk EG0011 events1 affected314 at risk
Acute myocardial infarction	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0014 events3 affected314 at risk
Angina pectoris	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Atrioventricular block complete	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Bradycardia	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Cardiac failure	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Heart valve incompetence	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Myocardial ischaemia	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Sinus node dysfunction	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0011 events1 affected314 at risk
Ventricular tachycardia	Cardiac disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Anaemia	Blood and lymphatic system disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0014 events2 affected314 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDR 18.1	Non-systematic Assessment	EG0003 events3 affected312 at risk EG0010 events0 affected314 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0012 events1 affected314 at risk
Cerebral infarction	Nervous system disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Ischaemic stroke	Nervous system disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Syncope	Nervous system disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Transient ischaemic attack	Nervous system disorders	MedDR 18.1	Non-systematic Assessment	EG0002 events2 affected312 at risk EG0010 events0 affected314 at risk
Macular hole	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG0003 events3 affected312 at risk EG0010 events0 affected314 at risk
Optic ischaemic neuropathy	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Retinal detachment	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG0004 events3 affected312 at risk EG0010 events0 affected314 at risk
Retinal haemorrhage	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Retinal pigment epithelial tear	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Vitreous haemorrhage	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Peptic ulcer	Gastrointestinal disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Rectal prolapse	Gastrointestinal disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Renal cyst	Renal and urinary disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Renal failure	Renal and urinary disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Urethral stenosis	Renal and urinary disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0011 events1 affected314 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Goitre	Endocrine disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Aspergillus infection	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Bronchitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0002 events1 affected312 at risk EG0010 events0 affected314 at risk
Cellulitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0011 events1 affected314 at risk
Chlostridium difficile colitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0012 events1 affected314 at risk
Device related sepsis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Diverticulitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Endophthalmitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0006 events6 affected312 at risk EG0012 events2 affected314 at risk
Gastroenteritis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0011 events1 affected314 at risk
Gastrointestinal infection	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Infectious colitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Pneumonia	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0012 events2 affected314 at risk
Pneumonia staphylococcal	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Pyelonephritis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Skin infection	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Urinary tract infection	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Vestibular neuronitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG0001 events1 affected312 at risk EG0010 events0 affected314 at risk
Hepatic encephalopathy	Nervous system disorders	MedDR 18.1	Non-systematic Assessment	EG0000 events0 affected312 at risk EG0011 events1 affected314 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctival haemorrhage	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG000166 events74 affected312 at risk EG001136 events50 affected314 at risk
Punctate keratitis	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG00093 events35 affected312 at risk EG00197 events40 affected314 at risk
Conjuctival hyperaemia	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG00048 events24 affected312 at risk EG00153 events24 affected314 at risk
Eye pain	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG00051 events22 affected312 at risk EG00135 events21 affected314 at risk
Vitreous floaters	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG00028 events22 affected312 at risk EG00113 events12 affected314 at risk
Eye irritation	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG00034 events18 affected312 at risk EG00135 events15 affected314 at risk
Keratitis	Eye disorders	MedDR 18.1	Non-systematic Assessment	EG00064 events18 affected312 at risk EG00147 events14 affected314 at risk
Nasopharyngitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG00018 events17 affected312 at risk EG00120 events18 affected314 at risk
Urinary tract infection	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG00023 events17 affected312 at risk EG00125 events18 affected314 at risk
Bronchitis	Infections and infestations	MedDR 18.1	Non-systematic Assessment	EG00018 events16 affected312 at risk EG00112 events11 affected314 at risk
Intraocular pressure increased	Investigations	MedDR 18.1	Non-systematic Assessment	EG000101 events49 affected312 at risk EG00142 events25 affected314 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Tucson	Arizona	85704	United States

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases
D014603	Uveal Diseases
D009389	Neovascularization, Pathologic
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000621266	E10030 aptamer
D000069579	Ranibizumab
C005703	salicylhydroxamic acid

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