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The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocriplasmin | Experimental | Ocriplasmin administered as a single intravitreal injection to the study eye at baseline |
|
| Sham injection | Sham Comparator | Single sham injection to the study eye at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocriplasmin | Drug |
|
| |
| Sham injection |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) | VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage. | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Group Manager, Clinical Development | Alcon Japan, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon for Trial Locations | Tokyo | Japan |
Of the 251 enrolled, 79 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (172).
Subjects were recruited from 40 study centers located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocriplasmin | Single intravitreal injection to the study eye at baseline |
| FG001 | Sham Injection | Single sham injection to the study eye at baseline |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all randomized subjects, as randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin | Single intravitreal injection to the study eye at baseline |
| BG001 | Sham Injection | Single sham injection to the study eye at baseline |
| 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 | Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) | VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage. | This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach. | Posted | Number | percentage of subjects | Day 28 |
|
Adverse events (AEs) were collected for the duration of the study (1 year, 2 months). This analysis group includes all subjects who received study medication, as treated. Note: One subject randomized to Ocriplasmin was inadvertently treated with Sham.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Ocular adverse events are presented for both study eye and non-study eye.
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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 | Ocriplasmin | Single intravitreal injection to the study eye at baseline |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular hole | Eye disorders | MedDRA/J (16.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA/J (16.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Group Manager, Clinical Development | Alcon Japan, Ltd. | +81368995277 |
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| ID | Term |
|---|---|
| D012607 | Scotoma |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C054561 | microplasmin |
| C005703 | salicylhydroxamic acid |
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| Drug |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Single sham injection to the study eye at baseline |
|
|
| 23 |
| 114 |
| 63 |
| 114 |
| EG001 | Sham Injection | Single sham injection to the study eye at baseline | 4 | 58 | 19 | 58 |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J (16.0) |
|
| Vitreous adhesions | Eye disorders | MedDRA/J (16.0) |
|
| Pneumonia | Infections and infestations | MedDRA/J (16.0) |
|
| Retinal detachment | Eye disorders | MedDRA/J (16.0) |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA/J (16.0) |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J (16.0) |
|
| Ocular hypertension | Eye disorders | MedDRA/J (16.0) |
|
| Angle closure glaucoma | Eye disorders | MedDRA/J (16.0) |
|
| Intraocular pressure increased | Investigations | MedDRA/J (16.0) |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J (16.0) |
|
| Macular pseudohole | Eye disorders | MedDRA/J (16.0) |
|
| Vitreous floaters | Eye disorders | MedDRA/J (16.0) |
|
| Anterior chamber cell | Eye disorders | MedDRA/J (16.0) |
|
| Eye pain | Eye disorders | MedDRA/J (16.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J (16.0) |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA/J (16.0) |
|
| Visual impairment | Eye disorders | MedDRA/J (16.0) |
|
| Corneal disorder | Eye disorders | MedDRA/J (16.0) |
|
| Punctate keratitis | Eye disorders | MedDRA/J (16.0) |
|
| Retinal detachment | Eye disorders | MedDRA/J (16.0) |
|
| Intraocular pressure increased | Investigations | MedDRA/J (16.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA/J (16.0) |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012164 | Retinal Diseases |