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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1142 | EXN407 Wiki | 0.58 |
| drug3941 | life questionnaires Wiki | 0.58 |
| drug1003 | Data collection up to 1 year Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012170 | Retinal Vein Occlusion NIH | 0.58 |
| D008268 | Macular Degeneration NIH | 0.41 |
| D011111 | Polymyalgia Rheumatica NIH | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0011505 | Cystoid macular edema HPO | 0.82 |
| HP:0012636 | Retinal vein occlusion HPO | 0.58 |
Navigate: Correlations HPO
There are 3 clinical trials
The containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased psychosocial stress with an increased risk of deterioration in their health status in the short, medium and long term. Some messages about the additional risk/danger associated with taking certain drugs in the event of COVID disease have been widely disseminated in the media since March 17, 2020, the date on which containment began in France. This is the case, for example, for corticosteroids, non-steroidal anti-inflammatory drugs but also for converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (ARBs2). These four major classes of drugs are widely prescribed in patients with chronic diseases, diseases specifically selected in our study (corticosteroids: haematological malignancies, multiple sclerosis, Horton's disease; ACE inhibitors/ARAs2: heart failure, chronic coronary artery disease). Aspirin used at low doses as an anti-platelet agent in coronary patients as a secondary prophylaxis after a myocardial infarction can be stopped by some patients who consider aspirin to be a non-steroidal anti-inflammatory drug. Discontinuation of this antiplatelet agent, which must be taken for life after an infarction, exposes the patient to a major risk of a new cardiovascular event. The current difficulty of access to care due to travel restrictions (a theoretical limit in the context of French confinement but a priori very real), the impossibility of consulting overloaded doctors, or the cancellation of medical appointments, medical and surgical procedures due to the reorganization of our hospital and private health system to better manage COVID-19 patients also increases the risk of worsening the health status of chronic patients who by definition require regular medical monitoring. Eight Burgundian cohorts of patients with chronic diseases (chronic coronary artery disease, heart failure, multiple sclerosis, Horton's disease, AMD, haemopathic malignancy, chronic respiratory failure (idiopathic fibrosis, PAH) haemophilia cohort) will study the health impact of the containment related to the COVID-19 pandemic.
Description: increase in dose, decrease in dose, discontinuation or no change for each drug class)
Measure: % adherence to each pharmacological class Time: during the period from 20 April 2020 to 7 May 2020Description: (mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)
Measure: number of occurrence of medical events at 1 year Time: throughout the study for 12 monthsDescription: Smoking/Smoking/sweetening, Alcohol consumption/recovery, Decreased physical activity, Weight change
Measure: Expressed in %: Non-pharmacological treatment/lifestyle: Time: during the period from 20 April 2020 to 7 May 2020In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Patients often have injections for many years, sometimes monthly or every 2 months. The discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the COVID-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.
Description: Change from baseline (last visual acuity before confinement) and visual acuity 6 months after resumption of follow-up
Measure: Change of visual acuity in patients treated with repeated IVT anti-angiogens during the COVID-19 epidemic Time: Baseline (Before confinement) and 6 months after resumption of follow-upThis first in human (FIH), Phase Ib/II study of EXN407 is a randomised, double-masked, vehicle-controlled, multiple dose, dose-escalating study to evaluate the safety and tolerability of EXN407 in subjects with centre involved Diabetic Macular Oedema (DMO), with Centre-subfield macular thickness (CMT) between 280-420 µm and Best corrected visual acuity (BCVA) better than approximate Snellen equivalent 20/32 (6/9, 78 letters) in the study eye, which is considered secondary to diabetes mellitus. For brevity, the BCVA criteria will be noted as 20/32 (6/9). This study will provide a basis for further clinical development of EXN407 ophthalmic solution.
Description: Measured by frequency and severity of ocular AEs in the study and contralateral eyes.
Measure: The primary objective of the study is to evaluate the ocular safety and tolerability (by incidence of ocular adverse events) of EXN407 ophthalmic solution in Dose Escalation phase. Time: Assessed starting from Day 1 of treatment to Day 36 in Dose Escalation.Description: Measured by frequency and severity of ocular AEs in the study and contralateral eyes.
Measure: The primary objective of the study is to evaluate the ocular safety and tolerability (by incidence of ocular adverse events) of EXN407 ophthalmic solution in Dose Expansion phase. Time: Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase.Description: Measured by characterizing the PK profile by estimating the time of the maximum plasma drug concentration (Tmax) of EXN407 in plasma.
Measure: To evaluate the systemic pharmacokinetics of EXN407 ophthalmic solution in subjects with DMO secondary to diabetes mellitus by Tmax. Time: Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.Description: Measured by characterizing the PK profile by estimating the maximum observed drug plasma concentration (Cmax) of EXN407 in plasma.
Measure: To evaluate the systemic pharmacokinetics of EXN407 ophthalmic solution in subjects with DMO secondary to diabetes mellitus by Cmax Time: Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.Description: Measured by characterizing the PK profile by estimating the area under the curve (AUC) of EXN407 in plasma.
Measure: To evaluate the systemic pharmacokinetics of EXN407 ophthalmic solution in subjects with DMO secondary to diabetes mellitus by AUC. Time: Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.Description: Measured by characterizing the PK profile by estimating the apparent elimination half-life (t½) of EXN407 in plasma.
Measure: To evaluate the systemic pharmacokinetics of EXN407 ophthalmic solution in subjects with DMO secondary to diabetes mellitus by t½. Time: Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.Description: Measured by the changes from baseline in ophthalmic examination finding through ophthalmoscopy.
Measure: To evaluate the percentage (%) of changes in ocular functional measures as assessed using ophthalmoscopy. Time: From Day 1 of Treatment to End of Treatment i.e. assessed upto 36 Days in Dose Escalation and upto 4 months(113 days) in Dose Expansion.Description: Measured by the changes from baseline in ophthalmic examination finding through ophthalmoscopy.
Measure: To evaluate the percentage (%) of changes in ocular structural measures as assessed using ophthalmoscopy. Time: From Day 1 of Treatment to End of Treatment i.e. assessed upto 36 Days in Dose Escalation and upto 4 months(113 days) in Dose Expansion.Alphabetical 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