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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4596 | mycophenolate mofetil (MMF) Wiki | 1.00 |
| drug139 | ASP7317 Wiki | 1.00 |
| drug2916 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation |
|---|
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 part of the eye that allows one to see fine detail. AMD causes cells in the macula to die (atrophy). This study is looking at a new treatment for slowing or reversing dry AMD, called ASP7317. ASP7317 is a specially created type of cells derived from stem cells. ASP7317 cells are injected into the macula of the eye. Immunosuppressive medicines (called IMT) are also taken around the time of injection of the cells to prevent the body from rejecting them. The study is divided into 3 stages. Stage 1 looks at the safety of ASP7317 at different dose levels. Researchers want to learn which of 3 different dose levels of ASP7317 work without causing unwanted effects. The doses are low, medium and high numbers of cells. IMT medicines will also be taken by mouth (oral) for 13 weeks around the time of the injection of ASP7317. In Stage 2, the participants are selected by chance (randomization) to be in the ASP7317 treatment group or to be in the control group (no treatment). What was learned about the dose of ASP7317 in stage 1 will be used to determine the appropriate dose(s) in this stage. In those who receive ASP7317, oral IMT medicines will also be taken for 13 weeks. 26 weeks after ASP3717 is injected, the best corrected visual acuity will be compared between participants who received ASP7317 and in those who did not (control group). Visual acuity is a test to find out what the smallest letters are that one can read on a standard chart. This test will be masked. Masked means the study opticians who measure one's visual acuity don't know whether the participant received ASP7317 or not. In Stage 3, participants in the untreated control group from stage 2 will have the option to receive treatment with ASP7317. They must have been in the study for 26 weeks and still meet the requirements for treatment.
Description: Best corrected visual acuity (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: PoC only: Change from baseline in BCVA score, measured by ETDRS method at week 26 Time: Baseline and Week 26Description: Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). Adverse event collection will begin upon the participant signing the informed consent.
Measure: Safety as assessed by Incidence, frequency and severity of adverse events (AEs) Time: Up to 60 MonthsDescription: An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (hospitalization for treatment/observation/examination caused by AE is to be considered as serious); or other medically important events.
Measure: Safety as assessed by Incidence, frequency and severity of Serious adverse events (SAEs) Time: Up to 60 MonthsDescription: ATIMP events which may represent a significant hazard to the trial's participant population, and thus require expedited reporting, including but not limited to the following example ATIMPs: ectopic or proliferative cell growth (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, IMT or ASP7317 (e.g., graft failure or rejection).
Measure: Safety as assessed by Incidence, frequency and severity of advanced therapy investigational medicinal product (ATIMP) events Time: Up to 60 MonthsDescription: Evidence of graft failure or rejection will be assessed by 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 graft failure or rejection Time: Up to 60 MonthsDescription: Evidence of graft failure or rejection will be assessed by 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 graft failure or rejection Time: Up to 60 MonthsDescription: Immediate notification (within 24 hours of becoming aware) to the sponsor is required for any evidence of graft failure or rejection. AEs which are assessed as being evidence of graft failure or rejection will be summarized in additional AE tables, including time to onset relative to the start of adjunct study medication.
Measure: Time of onset of ASP7317 to graft failure or rejection Time: Up to 60 MonthsDescription: An abnormality identified during a medical test will be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of adjunct study medications; age-related eye disease studies (AREDS) lens grade increase from baseline by ≥ 1 grade; the abnormality or test value is clinically significant; visual acuity loss of ≥ 10 letters due to graft failure or rejection.
Measure: Number of clinically significant objective test results in laboratory tests Time: Up to 26 WeeksDescription: Clinically significant changes in blood pressure will be reported as moderate or severe.
Measure: Number of clinically significant objective test results in blood pressure Time: Up to 12 WeeksDescription: Clinically significant changes in AC cells grade will be reported with a grade ranging from 0 to 4+ (0 = good and 4+ = not good), on a scale from <1 to >50, with cells in field as the indicator (0 = <1 cells in the field and 4+ = >50 cells in the field).
Measure: Number of clinically significant objective test results in anterior chamber (AC) cells grade Time: Up to 26 WeeksDescription: Clinically significant changes in flare grade will be reported with a grade ranging from 0 to 4+ and defined as follows: none (grade 0), faint (grade 1), moderate (iris and lens details clear, grade 2), marked (iris and lens details hazy, grade 3), and intense (fibrin or plastic aqueous, grade 4).
Measure: Number of clinically significant objective test results in AC flare grade Time: Up to 26 WeeksDescription: Clinically significant changes in vitreous haze grade will be reported with a grade ranging from 0 to 4+ and defined as follows: clear (grade 0), opacities without obstruction of retinal details (grade 1), few opacities resulting in the mild burning of posterior details of optic nerve and retinal vessels (grade 2), optic nerve head and retinal vessels significantly blurred but still visible (grade 3), dense opacity obscuring optic nerve head (grade 4).
Measure: Number of clinically significant objective test results in vitreous haze grade Time: Up to 26 WeeksDescription: Intraocular pressure in both eyes will be measured by tonometry. Intraocular pressure should be measured after biomicroscopic examination and before pupil dilation approximately the same time of day, when possible.
Measure: Number of clinically significant objective test results in intraocular pressure (IOP) in each eye Time: Up to 60 MonthsDescription: BCVA will be measured by an assessor certified to use the ETDRS method. The BCVA score (in letter units) will be reported.
Measure: PoC only: Change from baseline in BCVA score, average of assessments from weeks 4 to 26 Time: Baseline and up to Week 26Description: BCVA will be measured by an assessor certified to use the ETDRS method.
Measure: PoC only: Participant response, defined as a confirmed ≥ 10-letter (0.2 logMAR) improvement in BCVA, at week 26 Time: Week 26Description: The index quadrant is defined as the macular quadrant (superior, temporal, inferior or nasal) where ASP7317 is injected or, for the untreated control group, this is the macular quadrant recommended for ASP7317 injection by the subject selection committee (SSC).
Measure: PoC only: Change from baseline in mean retinal sensitivity of all test points in the index quadrant at week 26 Time: Baseline and Week 26Description: DDAF will be assessed by Fundus Autofluorescence Photography (FAF). The image reading center will review the FAF images for area of DDAF and pattern of hyper autofluorescence around the DDAF.
Measure: PoC only: Change from baseline in (square root) area of definite decreased autofluorescence (DDAF) in the index quadrant at week 26 Time: Baseline and Week 26Description: The FRII is a 7-item questionnaire that evaluates the effect of geographic atrophy on a patient's ability to independently perform reading activities.
Measure: Change from baseline in the Functional Reading Independence Index (FRII) at week 26 Time: Baseline and Week 26Description: The IVI-VLV questionnaire (28 questions) will be used to assess activities of daily living, mobility, safety and emotional well-being. This questionnaire measures perceived restriction of participation associated with daily living activities.
Measure: Change from baseline in the Impact of Vision Impairment - Very Low Vision questionnaire (IVI-VLV) at week 26 Time: Baseline and Week 26Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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