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The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocriplasmin | Experimental |
| |
| Sham injection | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocriplasmin | Drug | 0.125 mg single intravitreal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 | Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 | ≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method. | Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Retina-Vitreous Associates Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34250257 | Derived | Velaga SB, Nittala MG, Ip MS, Duchateau L, Sadda SR. Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial. BMJ Open Ophthalmol. 2021 Jun 21;6(1):e000648. doi: 10.1136/bmjophth-2020-000648. eCollection 2021. | |
| 30350717 | Derived |
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This study was conducted at 25 study sites in the United States. The first subject was enrolled on 02 November 2011 and the last subject completed the study on 22 October 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocriplasmin | Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg |
| FG001 | Sham | Subjects in the sham group received a single sham injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sham injection |
| Other |
Sham injection |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| Retina Consultants Medical Group | Sacramento | California | 95819 | United States |
| West Coast Retina Group, Inc | San Francisco | California | 94107 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| MedEye Associates | Miami | Florida | 33143 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Associated Retinal Consultants | Royal Oak | Michigan | 48073 | United States |
| Sabates Eye Center Research | Kansas City | Missouri | 64108 | United States |
| Eyesite Opthalmic Services, PA | Portsmouth | New Hampshire | 03801 | United States |
| Retina-Vitreous Center, PA | New Brunswick | New Jersey | 08901 | United States |
| Retina Association of NJ | Teaneck | New Jersey | 07666 | United States |
| Retina Vitrous Surgeons of CNY | Syracuse | New York | 13224 | United States |
| Southeast Clinical Research, PA | Charlotte | North Carolina | 28210 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Retina Associates of Cleveland | Cleveland | Ohio | 44130 | United States |
| Mid Atlantic Retina | Huntingdon Valley | Pennsylvania | 19006 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants, PA | Fort Worth | Texas | 76104 | United States |
| Vitroretinal Consultants | Houston | Texas | 77030 | United States |
| Valley Retina Institute, P.A. | McAllen | Texas | 78503 | United States |
| Retina Consultants of San Antonio | San Antonio | Texas | 78240 | United States |
| Eye Care Associate | Tyler | Texas | 75701 | United States |
| Yu TM, Dugel PU, Haller JA, Kaiser PK, Arnold RJ. Budget impact analysis of ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the USA. J Comp Eff Res. 2018 Dec;7(12):1195-1207. doi: 10.2217/cer-2018-0057. Epub 2018 Oct 23. |
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| NOT COMPLETED |
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Safety Set: The Safety Set consists of all subjects who received treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin | Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg |
| BG001 | Sham | Subjects in the sham group received a single 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 Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 | Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method. | Full Analysis Set (FAS): The FAS is the set of all randomized subjects who received the initial treatment, and for whom data of at least 1 post-injection efficacy assessment was present. Two (2) subjects (1 in each treatment group) were excluded from the FAS as they withdrew consent and did not attend any of the post-injection visits. | Posted | Number | 95% Confidence Interval | Percentage (weighted across strata) | Day 28 |
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| Secondary | Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 | ≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method. | FAS. 1 subject did not have BCVA results at baseline and was excluded from this analysis. | Posted | Number | 95% Confidence Interval | Percentage (weighted across strata) | Month 24 |
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Adverse events were collected from the injection day (Day 0) up to discontinuation from the study or completion of the study (Month 24).
The Safety Set consisted of all subjects who received study treatment and was used for all safety analyses. All subjects were included in the Safety Set: 146 subjects in the ocriplasmin group and 74 subjects in the sham group.
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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 | Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg | 49 | 146 | 132 | 146 | ||
| EG001 | Sham | Subjects in the sham group received a single sham injection | 27 | 74 | 57 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular hole | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Vitreous adhesions | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Night blindness | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Pupillary reflex impaired | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Retinal toxicity | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Retinal vasculitis | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Localized infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Coccidioidomycosis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
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| Retinogram abnormal | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Adrenal gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
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| Adrenocortical carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
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| Gastrointestinal stromal tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
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| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
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| Chronic myelomonocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
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| Endometrial cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
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| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Large intestinal stenosis | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Burns third degree | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
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| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
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| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Adrenalectomy | Surgical and medical procedures | MedDRA version 17.1 | Non-systematic Assessment |
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| Hip surgery | Surgical and medical procedures | MedDRA version 17.1 | Non-systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Femoral artery occlusion | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous floaters | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Photopsia | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Cataract nuclear | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Macular fibrosis | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Posterior capsule opacification | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Subretinal fluid | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Chromatopsia | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Conjunctival hemorrhage | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Metamorphopsia | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Retinal hemorrhage | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Retinal pigment epitheliopathy | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Macular hole | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Cystoid macular edema | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Retinal tear | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Cataract cortical | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Color vision tests abnormal | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
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| Ophthalmological examination abnormal | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
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| Visual acuity tests abnormal | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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Sponsor shall have the right to the 1st publication of the Study results (joint, multi-center publication in conjunction with PI). Following the 1st publication, PI may publish data/results from the Study; provided that PI submits the proposed publication to Sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may request that Confidential/Proprietary Information be deleted and/or publication be postponed to protect Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Petra Kozma-Wiebe | ThromboGenics N.V. | +32 16 751 497 | petra.kozma@thrombogenics.com |
| ID | Term |
|---|---|
| C054561 | microplasmin |
| C005703 | salicylhydroxamic acid |
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| Male |
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|