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Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.
Part 1 is a randomized, double-maskedtrial trial designed to investigate the use of TLC399 in subjects with macular edema due to CRVO or BRVO. Three different dose strengths will be evaluated.
Part 2 is a randomized, double-masked study designed to evaluate 2 doses of TLC399 in subjects with macular edema due to CRVO or BRVO. Subjects will be randomized 1:1 to receive two different dose strenghs of investigational product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | TLC399 (ProDex) 0.36mg DSP with 100 mM PL |
|
| Group 2 | Experimental | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL |
|
| Group 3 | Experimental | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL |
|
| Group 4 | Experimental | TLC399 (ProDex) 0.84 mg DSP with 50 mM PL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLC399 (ProDex) | Drug | 2-vial system: TLC399-DSP and TLC399-Lipid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye | Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye. Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters. | 6 months after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Shih | Taiwan Liposome Company, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute | Phoenix | Arizona | 85014 | United States | ||
| Retina Institute of California |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
| FG001 | Group 2 | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2018 |
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| Arcadia |
| California |
| 91007 |
| United States |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Retina Institute of California | Palm Desert | California | 92260 | United States |
| Colorado Retina Associates | Golden | Colorado | 80401 | United States |
| Retina Group of New England | New London | Connecticut | 09320 | United States |
| Retina Macula Specialists of Miami | Miami | Florida | 33126 | United States |
| Georgia Retina, P.C | Marietta | Georgia | 30060 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Retina Consultants of Nevada | Las Vegas | Nevada | 89149 | United States |
| Retina Associates of Western New York, PC | Rochester | New York | 14620 | United States |
| Charlotte Eye Ear Nose & Throat Assoc, PA | Charlotte | North Carolina | 28210 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44915 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Houston,The Woodlands | The Woodlands | Texas | 77384 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| FG002 | Group 3 | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
| FG003 | Group 4 | TLC399 (ProDex) 0.84 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
| COMPLETED |
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| NOT COMPLETED |
|
Baseline analysis population was based on mITT population, which was defined as subjects who had at least 1 post-treatment efficacy evaluation
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
| BG001 | Group 2 | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
| BG002 | Group 3 | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
| BG003 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| RVO Type | Count of Participants | Participants | No |
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| CST (study eye) | Mean | Standard Deviation | µm |
| |||||||||||||||
| BCVA (study eye) | Mean | Standard Deviation | letters |
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| IOP (study eye) | Mean | Standard Deviation | mmHg |
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| 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 BCVA Gain of 15 or More Letters From Baseline in the Study Eye | Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye. Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters. | The analysis population was based on subject's randomized treatment group. | Posted | Count of Participants | Participants | 6 months after dosing |
|
|
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14 days (screening) + 1 year
Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events.
The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
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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 | Group 1 | TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | 0 | 10 | 0 | 10 | 10 | 10 |
| EG001 | Group 2 | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | 0 | 8 | 2 | 8 | 8 | 8 |
| EG002 | Group 3 | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | 0 | 13 | 1 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous haze | Eye disorders | Systematic Assessment |
| ||
| Vitreous haze leading to significant vision loss | Eye disorders | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Acute coliti | Gastrointestinal disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous haze | Eye disorders | Systematic Assessment |
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| Macular oedema | Eye disorders | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
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| Vitreous floaters | Eye disorders | Systematic Assessment |
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| Vision blurred | Eye disorders | Systematic Assessment |
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| Corneal oedema | Eye disorders | Systematic Assessment |
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| Retinal vein occlusion | Eye disorders | Systematic Assessment |
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| Optic disc hyperaemia | Eye disorders | Systematic Assessment |
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| Retinal aneurysm | Eye disorders | Systematic Assessment |
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| Retinal vascular disorder | Eye disorders | Systematic Assessment |
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| Visual imparment | Eye disorders | Systematic Assessment |
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| Vitrous detachment | Eye disorders | Systematic Assessment |
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| Anterior chamber flare | Eye disorders | Systematic Assessment |
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| Cataract | Eye disorders | Systematic Assessment |
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| Cataract nulcear | Eye disorders | Systematic Assessment |
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| Conjunctival cyst | Eye disorders | Systematic Assessment |
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| Dry eye | Eye disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Iris neovascularisation | Eye disorders | Systematic Assessment |
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| Macular fibrosis | Eye disorders | Systematic Assessment |
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| Macular pigmentation | Eye disorders | Systematic Assessment |
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| Maculopathy | Eye disorders | Systematic Assessment |
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| Retinal disorder | Eye disorders | Systematic Assessment |
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| Retinal exudates | Eye disorders | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | Systematic Assessment |
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| Retinal neovascularisation | Eye disorders | Systematic Assessment |
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| Retinal scar | Eye disorders | Systematic Assessment |
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| Vitreous disorder | Eye disorders | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | Systematic Assessment |
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| Vitreous opacities | Eye disorders | Systematic Assessment |
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| Retinal thickening | Eye disorders | Systematic Assessment |
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| Intraocular pressure increased | Investigations | Systematic Assessment |
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| Medication residue present | Investigations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood potassium increased | Investigations | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
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| Blood cholesterol increased | Investigations | Systematic Assessment |
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| Blood urea increased | Investigations | Systematic Assessment |
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| Cardiac murmur | Investigations | Systematic Assessment |
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| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Heart rate irregular | Investigations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Glycosuria | Renal and urinary disorders | Systematic Assessment |
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| Nephropathy | Renal and urinary disorders | Systematic Assessment |
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| Renal artery occlusion | Renal and urinary disorders | Systematic Assessment |
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| Urine abnormality | Renal and urinary disorders | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
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| Dementia | Nervous system disorders | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carl Brown | Taiwan Liposome Company | 886-2-2655-7377 | tlc_clinicaltrials@tlcbio.com |
| Nov 24, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| CRVO |
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