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
This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocriplasmin | Experimental |
| |
| Sham injection | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocriplasmin | Drug | ocriplasmin intravitreal injection (125 µg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 | The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation | Day 28 |
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 |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Retinal Consultants Medical Group |
Not provided
First subject was enrolled on 29 Jan 2010 and last subject completed the study on 06 Dec 2012
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ocriplasmin | Intravitreal injection (125 µg) |
| FG001 | Sham | Sham injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham injection |
| Drug |
Sham injection |
|
| Sacramento |
| California |
| 95819 |
| United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Center for Retina and Maculla Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | United States |
| VitreoRetinal Surgery, PA | Minneapolis | Minnesota | 55435 | United States |
| Retina-Vitreous Center, PA | New Brunswick | New Jersey | 08901 | United States |
| Allegheny Ophthalmic & Orbital Associates, PC | Pittsburgh | Pennsylvania | 15212 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Southeastern Retina Associates | Kingsport | Tennessee | 37660 | United States |
| Retinal Consultants of Houston, | Houston | Texas | 78730 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| U.Z. Leuven St. Rafaël Hospital | Leuven | B-3300 | Belgium |
| Rabelais Ophthalmologic Center | Lyon | F-69003 | France |
| Centre Paradis-Monticelli | Marseille | F-13008 | France |
| Centre Ophtalmologique d'Imagerie et de Laser | Paris | 75015 | France |
| Centre Ophtalmologique de L'Odeon | Paris | F75006 | France |
| Universität Bonn Augenklinik | Bonn | D-53127 | Germany |
| Universität Lübeck Universitätsklinikum Schleswig-Holstein | Lübeck | D-23538 | Germany |
| Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg | Marburg | D-35043 | Germany |
| Augenklinik der Ludwig Maximilians Universität München | München | 80336 | Germany |
| University of Milan Department of Clinical Science "Luigi Sacco" | Milan | Italy |
| Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology | Rome | I-00168 | Italy |
| Frimley Park Hospital | Frimley | Camberley | GU16 7UJ | United Kingdom |
| Royal Liverpool & Broadgreen Hospital | Liverpool | L7 8XP | United Kingdom |
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
| Wolverhampton Eye Infirmary New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): All randomized subjects who have been administered trial medication and for whom data of at least one post-baseline efficacy assessment is available. One subject (ocriplasmin) was not included in the FAS because the subject withdrew consent after receiving study treatment and refused further contact.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin | Intravitreal injection (125 µg) |
| BG001 | Sham | Sham injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 | The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation | The Full Analysis Set (FAS) was the primary data set for efficacy analysis. Data that were missing for any reason were imputed using the Last Observation Carried Forward (LOCF) method. | Posted | Number | percentage of subjects | Day 28 |
|
|
|
|
Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection.
Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
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 | Intravitreal injection (125 µg) | 18 | 75 | 33 | 75 | ||
| EG001 | Sham | Sham injection | 2 | 25 | 11 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Vocal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vocal cordectomy | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Ateriosclerosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Conjuctival haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Metamorphosia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
Institution and the Principal Investigator (PI) reserve the right to publish only the results of the work performed by the Principal Investigator pursuant to this Agreement; provided, however, that Institution provides Sponsor a copy of any proposed publication, for review and comment at least sixty (60) days in advance of its submission for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Petra Kozma-Wiebe | ThromboGenics NV | +32 16 751 310 | Petra.kozma@thrombogenics.com |
| ID | Term |
|---|---|
| C054561 | microplasmin |
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
| Male |
|