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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005464-25 | EudraCT Number |
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The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.
After receiving a single intravitreal injection as per country's product label (Day 0), subjects were followed for a 6-month period (Day 180).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocriplasmin | Experimental | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocriplasmin | Drug | 0.5 mg/0.2 mL solution for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation | Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis. | Baseline, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance | BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr Clinical Manager, Ophtha-GCRA | Alcon, a Novartis Company | Study Director |
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Of the 628 enrolled, 160 subjects were exited prior to initiation of treatment. This reporting group includes all treated subjects (468).
Subjects were recruited from 87 study centers located in Europe and Canada (10 Italy, 5 Netherlands, 4 Poland, 4 Portugal, 12 Spain, 15 United Kingdom, 3 Belgium, 12 France, 9 Germany, 5 Hungary, and 8 Canada).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocriplasmin | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all subjects who were exposed to the Investigational Product (IP) (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation | Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who received treatment with IP and had at least one post-treatment measurement of SD-OCT (FAS). Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after timepoint of vitrectomy. | Posted | Number | percentage of subjects | Baseline, Day 28 |
Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 7 months). Ocular AEs are presented for both study eye and non-study eye combined. AEs are reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject regardless of the causal relationship to the study medication. AEs could be volunteered or solicited by the Investigator or study personnel.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | All subjects consented to participate in the study prior to the initiation of study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye operation | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| EMEA Medical Affairs Lead, Pharma | Alcon, a Novartis company | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| C054561 | microplasmin |
| D010958 | Plasminogen |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001609 | Beta-Globulins |
| D012712 | Serum Globulins |
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| Baseline (Day 0), Day 28, Day 90, Day 180 |
| Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline | The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis. | Day 28, Day 90, Day 180 |
| Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA | Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis. | Baseline, Day 90, Day 180 |
| Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180 | Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis. | Day 180 |
| Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT) | Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 28, Day 180 |
| Physician Decision |
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| Withdrawal by Subject |
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| Progressive Disease |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Ocriplasmin | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection |
|
|
| Secondary | Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance | BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | Full Analysis Set. Missing data imputed using LOCF. BCVA values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy. | Posted | Mean | Standard Deviation | letters | Baseline (Day 0), Day 28, Day 90, Day 180 |
|
|
|
| Secondary | Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline | The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis. | Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after MH closure were considered as 'no MH closure' after the timepoint of vitrectomy. | Posted | Number | percentage of subjects | Day 28, Day 90, Day 180 |
|
|
|
| Secondary | Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA | Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis. | Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after the timepoint of vitrectomy. | Posted | Number | percentage of subjects | Baseline, Day 90, Day 180 |
|
|
|
| Secondary | Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180 | Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis. | Full Analysis Set | Posted | Number | percentage of subjects | Day 180 |
|
|
|
| Secondary | Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT) | Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis. | Full Analysis Set. Missing data is imputed using LOCF. CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy. | Posted | Mean | Standard Deviation | micrometers | Baseline (Day 0), Day 28, Day 180 |
|
|
|
| 1 |
| 628 |
| 1 |
| 628 |
| EG001 | Ocriplasmin | All subjects exposed to the investigational product | 46 | 468 | 247 | 468 |
| Macular Hole | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Hip arthroplasty | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Cardioversion | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Ear operation | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Heart valve replacement | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Hip surgery | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Lithotripsy | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Renal stone removal | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Shoulder operation | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Rectal prolapse | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
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| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
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| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Left ventricular failure | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Pickwickian syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Colonoscopy | Investigations | MedDRA (16.0) | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Vitreous adhesions | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Ciliary zonular dehiscence | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Vitrectomy | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Photopsia | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Macular oedema | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Colour blindness acquired | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D011498 | Protein Precursors |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|
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