A Study to Evaluate the Efficacy and Safety of Ocriplasmi... | NCT02681809

ID	Type	Description	Link
2015-002415-15	EudraCT Number

Label	Type	Intervention Names
Ocriplasmin 0.0625mg	Experimental	Drug: ocriplasmin 0.0625mg
Ocriplasmin 0.125mg	Experimental	Drug: ocriplasmin 0.125mg
Sham injection	Sham Comparator	Drug: Sham injection

Name	Type	Description	Arm Group Labels	Other Names
ocriplasmin 0.0625mg	Drug	Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart	Ocriplasmin 0.0625mg

Measure	Description	Time Frame
Number of Subjects With Total PVD by the Month 3 Visit	Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres	Month 3

Measure	Description	Time Frame
Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye	Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting	From first injection until the end of the study (Month 24)

Name	Affiliation	Role
Clinical Department	ThromboGenics	Study Director

ID	Title	Description
FG000	Ocriplasmin 0.0625mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
FG001	Ocriplasmin 0.125mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 28, 2016	Nov 12, 2020

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

Number of Subjects With Total PVD by the Month 3 Visit

Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres

All Treated Subjects with B-scan ultrasound and SD-OCT assessments at Month 3

Posted

Count of Participants

Participants

Month 3

ID	Title	Description
OG000	Ocriplasmin 0.0625mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
OG001	Ocriplasmin 0.125mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
OG002	Sham Injection	Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.

Units	Counts
Participants	OG00020 OG00118 OG0028

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020

Secondary

Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye

Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting

All Treated Subjects

Posted

Count of Participants

Participants

From first injection until the end of the study (Month 24)

ID	Title	Description
OG000	Ocriplasmin 0.0625mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
OG001	Ocriplasmin 0.125mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
OG002	Sham Injection	Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Peripheral Ischaemia	Vascular disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Craniocerebral Injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0021 events1 affected9 at risk
Fibula Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Patella Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Adenocarcinoma of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Cardiac Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Cardiac Failure Congestive	Cardiac disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Cerebrovascular Accident	Nervous system disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Ciliary Zonular Dehiscence	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Retinal Haemorrhage	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Uveitis	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Generalised Oedema	General disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Non-Cardiac Chest Pain	General disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events1 affected19 at risk EG0020 events0 affected9 at risk
Respiratory Tract Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events1 affected19 at risk EG0020 events0 affected9 at risk
Abdominal Wall Abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Catheter Site Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Endophthalmitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0013 events2 affected19 at risk EG0021 events1 affected9 at risk
Deep Vein Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Hypertensive Crisis	Vascular disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Peripheral Ischaemia	Vascular disorders	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Malaise	General disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0022 events1 affected9 at risk
Gait Disturbance	General disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Injection Site Haemorrhage	General disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Injection Site Pain	General disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Post Procedural Oedema	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Radius Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Intraocular Pressure Increased	Investigations	Systematic Assessment	EG0006 events4 affected20 at risk EG0010 events0 affected19 at risk EG0022 events1 affected9 at risk
Glycosylated Haemoglobin Increased	Investigations	Systematic Assessment	EG0000 events0 affected20 at risk EG0013 events3 affected19 at risk EG0020 events0 affected9 at risk
Intraocular Pressure Decreased	Investigations	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Cardiac Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Colour Blindness	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0021 events1 affected9 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0002 events2 affected20 at risk EG0012 events2 affected19 at risk EG0020 events0 affected9 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0021 events1 affected9 at risk
Loss of Consciousness	Nervous system disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0021 events1 affected9 at risk
Paralysis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0021 events1 affected9 at risk
Eye Pain	Eye disorders	Systematic Assessment	EG0002 events2 affected20 at risk EG0017 events5 affected19 at risk EG0021 events1 affected9 at risk
Diabetic Retinal Oedema	Eye disorders	Systematic Assessment	EG0004 events4 affected20 at risk EG0013 events1 affected19 at risk EG0023 events2 affected9 at risk
Cataract	Eye disorders	Systematic Assessment	EG0004 events3 affected20 at risk EG0014 events3 affected19 at risk EG0020 events0 affected9 at risk
Visual Acuity Reduced	Eye disorders	Systematic Assessment	EG0002 events2 affected20 at risk EG0014 events4 affected19 at risk EG0020 events0 affected9 at risk
Vitreous Floaters	Eye disorders	Systematic Assessment	EG0002 events2 affected20 at risk EG0016 events3 affected19 at risk EG0020 events0 affected9 at risk
Conjunctival Haemorrhage	Eye disorders	Systematic Assessment	EG0004 events4 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Macular Oedema	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0015 events4 affected19 at risk EG0020 events0 affected9 at risk
Visual Impairment	Eye disorders	Systematic Assessment	EG0004 events3 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Vitreous Haemorrhage	Eye disorders	Systematic Assessment	EG0002 events1 affected20 at risk EG0013 events3 affected19 at risk EG0020 events0 affected9 at risk
Photophobia	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0014 events2 affected19 at risk EG0020 events0 affected9 at risk
Photopsia	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0014 events2 affected19 at risk EG0020 events0 affected9 at risk
Diabetic Retinopathy	Eye disorders	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected19 at risk EG0022 events2 affected9 at risk
Dry Eye	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0013 events2 affected19 at risk EG0021 events1 affected9 at risk
Eye Irritation	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0013 events2 affected19 at risk EG0021 events1 affected9 at risk
Macular Fibrosis	Eye disorders	Systematic Assessment	EG0003 events2 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Retinal Haemorrhage	Eye disorders	Systematic Assessment	EG0002 events2 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Vision Blurred	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected19 at risk EG0021 events1 affected9 at risk
Cataract Subcapsular	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0013 events2 affected19 at risk EG0020 events0 affected9 at risk
Lacrimation Increased	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected19 at risk EG0020 events0 affected9 at risk
Punctate Keratitis	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0021 events1 affected9 at risk
Cataract Cortical	Eye disorders	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Iridocyclitis	Eye disorders	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Lenticular Opacities	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events1 affected19 at risk EG0020 events0 affected9 at risk
Ocular Hypertension	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events1 affected19 at risk EG0020 events0 affected9 at risk
Cataract Nuclear	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Corneal Oedema	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Cystoid Macular Oedema	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Eyelid Ptosis	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Ocular Hyperaemia	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Optic Disc Haemorrhage	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Optic Nerve Disorder	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Retinal Aneurysm	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Retinal Cyst	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Retinal Detachment	Eye disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0021 events1 affected9 at risk
Retinal Exudates	Eye disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Gastrooesophageal Sphincter Insufficiency	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0002 events1 affected20 at risk EG0011 events1 affected19 at risk EG0021 events1 affected9 at risk
Dermatitis Herpetiformis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected19 at risk EG0020 events0 affected9 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0021 events1 affected9 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected20 at risk EG0013 events3 affected19 at risk EG0022 events2 affected9 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected19 at risk EG0020 events0 affected9 at risk
Localised Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected19 at risk EG0020 events0 affected9 at risk
Nosocomial Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected19 at risk EG0021 events1 affected9 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85021	United States

ID	Term
D003930	Diabetic Retinopathy
D020255	Vitreous Detachment
D018450	Disease Progression

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C054561	microplasmin
C005703	salicylhydroxamic acid

ID	Title	Description
BG000	Ocriplasmin 0.0625mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
BG001	Ocriplasmin 0.125mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
BG002	Sham Injection	Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ocriplasmin 0.0625mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart	20	5	20	16	20
EG001	Ocriplasmin 0.125mg	Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart	19	8	19	17	19
EG002	Sham Injection	Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.	9	1	9	7	9