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The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month period.
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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 (IVT) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocriplasmin 0.125 mg in a 0.1 mL volume | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA 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 according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. 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. One eye (study eye) contributed to the analysis. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Associate Dir of Operations, Ophthalmology, GMA | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Laboratories (Australia) for Trial Locations | New South Wales | 2113 | Australia |
Of the 62 enrolled, 10 subjects were exited as screen failures prior to initiation of treatment. This reporting group includes all eligible subjects (52).
Subjects were recruited from 9 sites located in Australia and 1 site located in New Zealand.
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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 (IVT) injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all subjects who received treatment with investigational product (IP) and had at least 1 post-treatment measurement of SD-OCT (Full 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 IVT 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 Subjects With Non-surgical Resolution of Focal VMT/sVMA 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 according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. 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. One eye (study eye) contributed to the analysis. | Full Analysis Set. Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMA resolution are considered as 'no VMA resolution' after timepoint of vitrectomy. | Posted | Number | percentage of subjects | Day 28 |
|
Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 7 months). AEs are reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment (ie, initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
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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 who consented to participate in the study prior to initiation of study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Worldwide Medical Affairs Director, GMA Retina Lucentis | Alcon, A Novartis Division | 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 7, Day 28, Day 90, Day 180 |
| Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (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. One eye (study eye) contributed to the analysis. | Day 7, Day 28, Day 90, Day 180 |
| Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180 | As described in Primary Outcome Measure | Baseline (Day 0), Day 7, Day 90, Day 180 |
| Percentage 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. One eye (study eye) contributed to the analysis. | Day 180 |
| Change From Baseline in Central Foveal Thickness at Days 28 and 180 | Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 28, Day 180 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Ocriplasmin |
Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection |
|
|
| Secondary | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. | Full Analysis Set. Missing data imputed using the LOCF method. BCVA values after a vitrectomy are imputed with the last non-missing value prior to the vitrectomy. | Posted | Mean | Standard Deviation | letters | Baseline (Day 0), Day 7, Day 28, Day 90, Day 180 |
|
|
|
| Secondary | Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (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. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects in Full Analysis Set with MH at baseline (n=4). Subjects who had vitrectomy after MH closure are considered as 'no MH closure' after the timepoint of vitrectomy. | Posted | Number | percentage of subjects | Day 7, Day 28, Day 90, Day 180 |
|
|
|
| Secondary | Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180 | As described in Primary Outcome Measure | Full Analysis Set. Missing data imputed for Days 90 and 180 using the LOCF method. Subjects who had vitrectomy are considered as 'no VMA resolution' after the timepoint of vitrectomy. | Posted | Number | percentage of subjects | Baseline (Day 0), Day 7, Day 90, Day 180 |
|
|
|
| Secondary | Percentage 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. One eye (study eye) contributed to the analysis. | Full Analysis Set | Posted | Number | percentage of subjects | Day 180 |
|
|
|
| Secondary | Change From Baseline in Central Foveal Thickness at Days 28 and 180 | Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. One eye (study eye) contributed to the analysis. | Missing data is imputed using the LOCF method. CFT values after a vitrectomy are imputed with the last non-missing value prior to the vitrectomy. | Posted | Mean | Standard Deviation | Microns | Baseline (Day 0), Day 28, Day 180 |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 1 |
| 62 |
| EG001 | Jetrea | Subjects exposed to Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection | 0 | 52 | 5 | 52 | 41 | 52 |
| Macular hole | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Metamorphopsia | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Photopsia | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | 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 |
|---|---|
|
| Change from BL at Day 90 |
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| Change from BL at Day 180 |
|
| Title | Measurements |
|---|
|
| Day 180 |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|