A Phase 3 Safety and Efficacy Study of Fovista® (E10030)... | NCT01944839

NCT01944839

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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00076.1± 7.98 BG00176.9± 8.04 BG002NA± NAnot calculated

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Adults 18-64 years

Title	Measurements
	BG00026 BG00120 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000181 BG001196 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000106 BG001104 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.

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	OG000309 OG001310

Title

Denominators

Categories

Title	Measurements
	OG00010.74± 0.86 OG0019.82± 0.86

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	6	310	48	310	123	310
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	2	309	36	309	114	309

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Aortic aneurysm	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Aortic stenosis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Hypertensive crisis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Gilioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Myxofibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Device malfunction	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Device failure	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Major depression	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0011 events1 affected309 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0013 events1 affected309 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 events3 affected310 at risk EG0013 events3 affected309 at risk
Atrial flutter	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 events2 affected310 at risk EG0011 events1 affected309 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0012 events2 affected309 at risk
Angina unstable	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Arrhythmia	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0011 events1 affected309 at risk
Cardiac fibrillation	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Conduction disorder	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 events3 affected310 at risk EG0010 events0 affected309 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 events2 affected310 at risk EG0010 events0 affected309 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Syncope	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 events2 affected310 at risk EG0010 events0 affected309 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0011 events1 affected309 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Epilepsy	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Subarachnoidal haemorrhage	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Cataract	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Cataract subcapsular	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Retinal tear	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Macular hole	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Visual acuity reduced	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 events3 affected310 at risk EG0010 events0 affected309 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Oroantral fistula	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0011 events1 affected309 at risk
Ureteric rupture	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 events1 affected310 at risk EG0010 events0 affected309 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 events2 affected310 at risk EG0010 events0 affected309 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Bone infarction	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0004 events4 affected310 at risk EG0011 events1 affected309 at risk
Endophthalmitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0003 events3 affected310 at risk EG0010 events0 affected309 at risk
Abdominal abscess	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Herpes zoster meningoencephalitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 events1 affected310 at risk EG0010 events0 affected309 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Diverticulitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0012 events2 affected309 at risk
Erysipelas	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Infected skin ulcer	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk
Sinusitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0012 events2 affected309 at risk
Wound infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 events0 affected310 at risk EG0011 events1 affected309 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intraocular pressure increased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG000157 events43 affected310 at risk EG00178 events30 affected309 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG000197 events60 affected310 at risk EG001177 events56 affected309 at risk
Eye pain	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG00029 events23 affected310 at risk EG00147 events26 affected309 at risk
Punctate keratitis	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG00022 events15 affected310 at risk EG00130 events18 affected309 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG00020 events19 affected310 at risk EG0016 events6 affected309 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85014	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