Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocriplasmin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocriplasmin | Drug | 175µg ocriplasmin intravitreal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). | Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope. | Beginning of vitrectomy or after application of suction |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Royal Oak | Michigan | 48073 | United States |
Not provided
First subject was recruited on 10 Feb 2010 and last subject completed the study on 14 Dec 2011.
24 study eyes (16 ocriplasmin, 8 placebo) were evaluated during the study. 22 subjects were enrolled in the study. 2 subjects were treated in both eyes.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ocriplasmin | Ocriplasmin : 175µg ocriplasmin intravitreal injection |
| FG001 | Placebo | Placebo : Placebo intravitreal injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
16 eyes randomized and treated (in 15 subjects) with ocriplasmin & 8 eyes randomized and treated (in 8 subjects) with placebo. Randomisation was at the eye not the subject level; in 1 subject, both eyes were randomised to ocriplasmin; in 1 subject, 1 eye was randomised to ocriplasmin & 1 eye randomised to placebo. 22 subjects participated, 24 eyes.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin | Ocriplasmin : 175µg ocriplasmin intravitreal injection |
| BG001 | Placebo | Placebo : Placebo intravitreal injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). | Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope. | Study eyes were analysed according to the Intent-to-Treat (ITT) principle, i.e. as randomised regardless of treatment received. The primary endpoint was evaluated using the Full Analysis Set (FAS), with missing data imputed using the Last Observation Carried Forward (LOCF) method. 1 subject contributed 1 eye to both treatment groups | Posted | Number | percentage of eyes | Beginning of vitrectomy or after application of suction | Eyes | Participants |
|
Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ocriplasmin | Ocriplasmin : 175µg ocriplasmin intravitreal injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shunt infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA (14.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Petra Kozma-Wiebe | ThromboGenics NV | +32 16751310 | petra.kozma@thrombogenics.com |
Not provided
| ID | Term |
|---|---|
| C054561 | microplasmin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo intravitreal injection |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
Placebo : Placebo intravitreal injection |
|
|
|
| 2 |
| 16 |
| 15 |
| 16 |
| EG001 | Placebo | Placebo : Placebo intravitreal injection | 2 | 8 | 8 | 8 |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Anterior chamber cell | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Anterior chamber flare | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Corneal epithelium defect | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Retinal disorder | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chorioretinal disorder | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chromatopsia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Conjunctival oedema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Corneal oedema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Corneal thickening | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cyclitic membrane | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Glaucomatous optic disc atrophy | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypotony of eye | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Optic atrophy | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Optic nerve disorder | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Retinal oedema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Retinal pigment epitheliopathy | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Angle closure glaucoma | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Anterior chamber fibrin | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cataract subcapsular | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ciliary zonular dehiscence | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Corneal opacity | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hyphaema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Iris adhesions | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Iris bombe | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Iris neovascularization | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lacrimal haemorrahge | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lens dislocation | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Optic nerve sheath haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pupillary disorder | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Retinopathy of prematurity | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Subretinal fibrosis | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vitreous adhesions | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vitreous disorder | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Shunt infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Optic nerve injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Retinal scar | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
Not provided