A Study of the Safety and Efficacy of Microplasmin to Ind... | NCT00412958

NCT00412958

Status Module

Sponsor/Collaborators Module

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
Ocriplasmin 25µg	Experimental	25µg of ocriplasmin intravitreal injection	Drug: Ocriplasmin 25µg
Ocriplasmin 75µg	Experimental	75µg of ocriplasmin intravitreal injection	Drug: Ocriplasmin 75µg
Ocriplasmin 125µg	Experimental	125µg of ocriplasmin intravitreal injection	Drug: Ocriplasmin 125µg
Placebo	Placebo Comparator	Intravitreal injection of placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ocriplasmin 25µg	Drug	Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.	Ocriplasmin 25µg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect	The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.	Day 7

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Retina Centers, P.C.		Tucson	Arizona	85704	United States
VMR Institute

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

ID	Title	Description
FG000	Ocriplasmin 25µg	25µg ocriplasmin intravitreal injection.
FG001	Ocriplasmin 75µg	75µg ocriplasmin intravitreal injection.

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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Ocriplasmin 25µg	25µg ocriplasmin intravitreal injection
BG001	Ocriplasmin 75µg	75µg ocriplasmin intravitreal injection.
BG002	Ocriplasmin 125µg	125µg ocriplasmin intravitreal injection.
BG003	Placebo	Intravitreal injection of placebo.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00029 BG00133 BG00232 BG00331 BG004125

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
	OG00013.8 OG00118.2 OG00231.3 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.	Regression, Logistic		0.796		Odds Ratio (OR)	1.24			2-Sided	95	0.24	6.36				No	Superiority or Other
OG001 OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ocriplasmin 25µg	25µg of ocriplasmin intravitreal injection.	2	29	29	29
EG001	Ocriplasmin 75µg	75µg of ocriplasmin intravitreal injection.	3	33	32	33
EG002	Ocriplasmin 125µg	125µg of ocriplasmin intravitreal injection.	0	32	31	32
EG003	Placebo	Intravitreal injection of placebo.	2	31	30	31

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diverticulitis	Infections and infestations	MedDRA version 10.1.	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected33 at risk EG0020 events0 affected32 at risk EG0030 events0 affected31 at risk
Pneumonia	Infections and infestations	MedDRA version 10.1.	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected33 at risk EG0020 events0 affected32 at risk EG003
Sinutis	Infections and infestations	MedDRA version 10.1.	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected33 at risk EG0020 events0 affected32 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA version 10.1.	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected33 at risk EG0020 events0 affected32 at risk EG003
Anterior chamber inflammation	Eye disorders	MedDRA version 10.1.	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected33 at risk EG0020 events0 affected32 at risk EG003
Radius fracture	Musculoskeletal and connective tissue disorders	MedDRA version 10.1.	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected33 at risk EG0020 events0 affected32 at risk EG003
Bening pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 10.1.	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected33 at risk EG0020 events0 affected32 at risk EG003
Hypertension	Vascular disorders	MedDRA version 10.1.	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected33 at risk EG0020 events0 affected32 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Conjunctival haemorrahge	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG00017 events14 affected29 at risk EG00122 events18 affected33 at risk EG00218 events17 affected32 at risk EG00322 events22 affected31 at risk
Anterior chamber cell	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG00013 events12 affected29 at risk EG00117 events13 affected33 at risk EG00216 events13 affected32 at risk EG003
Anterior chamber flare	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0006 events6 affected29 at risk EG0019 events7 affected33 at risk EG00212 events11 affected32 at risk EG003
Cataract nuclear	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG00013 events9 affected29 at risk EG0018 events7 affected33 at risk EG0029 events8 affected32 at risk EG003
Macular oedema	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0006 events5 affected29 at risk EG00111 events10 affected33 at risk EG0024 events4 affected32 at risk EG003
Cataract	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0006 events6 affected29 at risk EG0019 events9 affected33 at risk EG0029 events7 affected32 at risk EG003
Eye pain	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0007 events6 affected29 at risk EG00111 events9 affected33 at risk EG0025 events4 affected32 at risk EG003
Eyelid oedema	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0008 events7 affected29 at risk EG0013 events3 affected33 at risk EG0023 events3 affected32 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0009 events7 affected29 at risk EG0016 events6 affected33 at risk EG0026 events5 affected32 at risk EG003
Retinal tear	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0002 events2 affected29 at risk EG0017 events7 affected33 at risk EG0024 events4 affected32 at risk EG003
Retinal depigmentation	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0006 events6 affected29 at risk EG0017 events6 affected33 at risk EG0026 events6 affected32 at risk EG003
Ocular discomfort	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0005 events5 affected29 at risk EG0012 events2 affected33 at risk EG0024 events4 affected32 at risk EG003
Maculopathy	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0004 events4 affected29 at risk EG0016 events5 affected33 at risk EG0022 events2 affected32 at risk EG003
Vitreous floaters	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0002 events2 affected29 at risk EG0016 events5 affected33 at risk EG0024 events4 affected32 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0006 events4 affected29 at risk EG0012 events1 affected33 at risk EG0023 events3 affected32 at risk EG003
Retinal disorder	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0003 events3 affected29 at risk EG0013 events3 affected33 at risk EG0025 events4 affected32 at risk EG003
Cataract subcapsular	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0018 events4 affected33 at risk EG0020 events0 affected32 at risk EG003
Macular degeneration	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0002 events2 affected29 at risk EG0015 events4 affected33 at risk EG0020 events0 affected32 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0003 events2 affected29 at risk EG0015 events4 affected33 at risk EG0023 events2 affected32 at risk EG003
Anterior chamber inflammation	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0003 events3 affected29 at risk EG0010 events0 affected33 at risk EG0020 events0 affected32 at risk EG003
Conjunctival oedema	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0003 events3 affected29 at risk EG0012 events2 affected33 at risk EG0020 events0 affected32 at risk EG003
Photophobia	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0003 events3 affected29 at risk EG0011 events1 affected33 at risk EG0022 events2 affected32 at risk EG003
Visual disturbance	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0003 events3 affected29 at risk EG0011 events1 affected33 at risk EG0021 events1 affected32 at risk EG003
Foreign body sensation in eyes	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0014 events3 affected33 at risk EG0023 events3 affected32 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0002 events2 affected29 at risk EG0012 events2 affected33 at risk EG0023 events3 affected32 at risk EG003
Corneal disorder	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0011 events1 affected33 at risk EG0023 events3 affected32 at risk EG003
Lacrimation increased	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0014 events3 affected33 at risk EG0020 events0 affected32 at risk EG003
Vision blurred	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0002 events2 affected29 at risk EG0013 events3 affected33 at risk EG0022 events2 affected32 at risk EG003
Vitreous disorder	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0013 events3 affected33 at risk EG0021 events1 affected32 at risk EG003
Corneal bleeding	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0002 events2 affected29 at risk EG0010 events0 affected33 at risk EG0021 events1 affected32 at risk EG003
Eye pruritus	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0002 events2 affected29 at risk EG0012 events2 affected33 at risk EG0020 events0 affected32 at risk EG003
Photopsia	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0002 events2 affected29 at risk EG0010 events0 affected33 at risk EG0022 events2 affected32 at risk EG003
Cataract cortical	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0010 events0 affected33 at risk EG0020 events0 affected32 at risk EG003
Corneal oedema	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0010 events0 affected33 at risk EG0020 events0 affected32 at risk EG003
Retinal cyst	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0011 events1 affected33 at risk EG0020 events0 affected32 at risk EG003
Macular hole	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0012 events2 affected33 at risk EG0022 events2 affected32 at risk EG003
Corneal striae	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0012 events2 affected33 at risk EG0021 events1 affected32 at risk EG003
Eye inflammation	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0012 events2 affected33 at risk EG0020 events0 affected32 at risk EG003
Retinal degeneration	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0012 events2 affected33 at risk EG0020 events0 affected32 at risk EG003
Retinal detachment	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0014 events2 affected33 at risk EG0020 events0 affected32 at risk EG003
Intraocular pressure increased	Investigations	MedDRA version 10.1.	Systematic Assessment		EG0004 events4 affected29 at risk EG0015 events4 affected33 at risk EG0026 events6 affected32 at risk EG003
Intraocular pressure decreased	Investigations	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0011 events1 affected33 at risk EG0021 events1 affected32 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0012 events2 affected33 at risk EG0021 events1 affected32 at risk EG003
Headache	Nervous system disorders	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0012 events2 affected33 at risk EG0021 events1 affected32 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0011 events1 affected33 at risk EG0022 events2 affected32 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 10.1.	Systematic Assessment		EG0000 events0 affected29 at risk EG0015 events5 affected33 at risk EG0021 events1 affected32 at risk EG003
Oedema peripheral	General disorders	MedDRA version 10.1.	Systematic Assessment	Originally coded to General disorders and administration site conditions	EG0002 events2 affected29 at risk EG0011 events1 affected33 at risk EG0020 events0 affected32 at risk EG003
Asthenia	General disorders	MedDRA version 10.1.	Systematic Assessment	Originally coded to General disorders and administration site conditions	EG0000 events0 affected29 at risk EG0012 events2 affected33 at risk EG0020 events0 affected32 at risk EG003
Retinal oedema	Eye disorders	MedDRA version 10.1.	Systematic Assessment		EG0001 events1 affected29 at risk EG0012 events2 affected33 at risk EG0023 events3 affected32 at risk EG003

ID	Term
C054561	microplasmin