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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug5255 | tacrolimus Wiki | 1.00 |
drug146 | ASP7317 Wiki | 1.00 |
drug5034 | lung ultrasound Wiki | 0.71 |
Name (Synonyms) | Correlation | |
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D001284 | Atrophy NIH | 0.71 |
D008268 | Macular Degeneration NIH | 0.50 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
This study is for adults 50 years or older who are losing their clear, sharp central vision. Central vision is needed to be able to read and drive a car. They have been diagnosed with dry age-related macular degeneration (called dry AMD). The macula is the center part of the back of the eye that allows you to see fine detail. In an advanced stage of this disease, areas of the macula die (atrophy), resulting in vision loss. This is called geographic atrophy. This study is looking at a new treatment called ASP7317. It is for slowing or reversing atrophy in dry AMD. ASP7317 is a specially created type of cells derived from human stem cells. ASP7317 cells are injected into the macula of the eye while the person is under anesthesia (local or general). An immunosuppressive medicine (tacrolimus) is also taken around the time of injection of the cells to prevent the body from rejecting them. This study looks at how safe ASP7317 is at 3 different dose levels. Researchers want to learn if the different dose levels of ASP7317 work without causing unwanted medical problems. Each of the 3 doses will be given to 2 groups of people. The first group will be those who have severe vision loss. The second group will be those who have moderate vision loss. The doses are low, medium and high numbers of cells. Tacrolimus will be taken by mouth for 33 days, starting around the time of the injection of ASP7317. In addition, medicines to prevent infection will be taken by mouth for up to 4 weeks starting around the time ASP7317 cells are injected. Each week for the first 4 weeks after the ASP7317 cells have been injected, people taking part in the study will visit the clinic so the researchers can make assessments. Then they will visit again, at weeks 6, 8, 12, 16, 26, and 52 (last week of the study). A substudy will be available at some clinics. These clinics will use a special camera that will allow researchers to look at images of the macular atrophy over time.
Description: Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). An Adverse Event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of ASP7317, the adjunct study medications and the study procedures, whether or not considered related to ASP7317, the adjunct study medications and the study procedures. A Treatment Emergent Adverse Event (TEAE) is defined as an AE beginning or worsening in severity after starting administration of the adjunct study medication.
Measure: Safety as assessed by incidence, frequency and severity of treatment emergent adverse events (TEAES) Time: Up to 52 WeeksDescription: An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly or birth defect or other medically important events.
Measure: Safety as assessed by incidence, frequency and severity of Serious Adverse Events (SAEs) Time: Up to 52 WeeksDescription: AEs of special interest include: ectopic or proliferative cell growth (retinal pigment epithelial/epithelium (RPE) or non-RPE) with adverse clinical consequence; any new diagnosis of an immune-mediated disorder; any new cancer, irrespective of prior history; unexpected, clinically significant AEs possibly related to the cell transplant procedure; immunosuppressive therapy (IMT) or ASP7317 (e.g., graft failure or rejection).
Measure: Safety assessed by Adverse Events (AEs) of special interest Time: Up to 52 WeeksDescription: Evidence of cellular graft failure or rejection will be assessed by best corrected visual acuity (BCVA), slit lamp examination, dilated indirect ophthalmoscopy, fundus photographs, spectral domain-optical coherence tomography (SD-OCT) and fluorescein angiography (FA), when performed.
Measure: Number of participants with cellular graft failure or rejection Time: Up to 52 WeeksDescription: Evidence of cellular graft failure or rejection will be assessed by best corrected visual acuity (BCVA), slit lamp examination, dilated indirect ophthalmoscopy, fundus photographs, spectral domain-optical coherence tomography (SD-OCT) and fluorescein angiography (FA), when performed.
Measure: Incidence of cellular graft failure or rejection Time: Up to 52 WeeksDescription: GA will be measured by blue-light and near-infrared fundus autofluorescence (NIR FAF) (definitely decreased autofluorescence (DDAF)) and spectral domain-optical coherence tomography (SD-OCT) (area of ellipsoid zone (EZ) defect, area of outer nuclear layer (ONL) defect).
Measure: Mean change from baseline in area of Geographic Atrophy (GA) (mm^2) in study eye and fellow eye Time: Baseline, Weeks 26 and 52/End of Study (EOS)Description: GA will be measured by blue-light and near-infrared fundus autofluorescence (NIR FAF) (definitely decreased autofluorescence (DDAF)) and spectral domain-optical coherence tomography (SD-OCT) (area of ellipsoid zone (EZ) defect, area of outer nuclear layer (ONL) defect).
Measure: Mean percent change from baseline in area of Geographic Atrophy (GA) (mm^2) in study eye and fellow eye Time: Baseline, Weeks 26 and 52/End of Study (EOS)Description: GA will be measured by blue-light and near-infrared fundus autofluorescence (NIR FAF) (definitely decreased autofluorescence (DDAF)) and spectral domain-optical coherence tomography (SD-OCT) (area of ellipsoid zone (EZ) defect, area of outer nuclear layer (ONL) defect).
Measure: Mean change from baseline in the square root transformation of Geographic Atrophy (GA) area in study eye and fellow eye Time: Baseline, Weeks 26 and 52/End of Study (EOS)Description: BCVA will be measured by an assessor certified to use the Early Treatment of Diabetic Retinopathy Study (ETDRS) method. The BCVA score (in letter units) will be reported.
Measure: Mean change from baseline in best corrected visual acuity (BCVA) score in study eye and fellow eye Time: Baseline, Weeks 1, 4, 6, 8, 12, 16, 26 and 52/End of Study (EOS)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports