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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3557 | RTH258/Brolucizumab Wiki | 0.71 |
| drug1266 | Data collection up to 1 year Wiki | 0.50 |
| drug5255 | tacrolimus Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D057135 | Wet Macular Degeneration NIH | 0.71 |
| D057092 | Geographic Atrophy NIH | 0.50 |
| D012170 | Retinal Vein Occlusion NIH | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012636 | Retinal vein occlusion HPO | 0.50 |
| HP:0011505 | Cystoid macular edema HPO | 0.29 |
Navigate: Correlations HPO
There are 4 clinical trials
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)Neovascular age-related macular degeneration (nAMD) is characterized by the presence of choroidal neovascularization (CNV). Choroidal neovascularization consists of abnormal blood vessels originating from the choroid and can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss. The safety and efficacy of brolucizumab has been demonstrated in 2 randomized, multicenter, double-masked, active controlled Phase 3 studies in nAMD patients (RTH258-C001 and RTH258-C002). Anatomical changes were evaluated in these studies using spectral domain optical coherence tomography (SD-OCT), which relied on indirect parameters for the diagnosis of active CNV. The OCT-angiography (OCT A) that directly visualize retinal circulation and image CNV and vascular diseases of the retina was not included in previous brolcuizumab studies. This single-arm, open-label, multicenter study is being performed to evaluate the efficacy and safety of brolucizumab 6 mg in patients with nAMD. OCT-A will be used in this study to assess the morphological response of patients to brolucizumab in terms of percentage change in CNV lesion area in the short term (i.e. at Week 12) and in the long term (i.e. at Week 48), as well as changes in other OCT-A features up to Week 48. Approximately 428 adult patients will be screened and included in approximately 75 centers in France. The maximum study duration for 1 patient is 48 weeks. Patients will be required to attend 6 mandatory study visits: Screening/Baseline Visit (Day 1), Week 4, Week 8, Week 12, Week 16 and Week 48 visits. The timing of the interim visits between Week 16 and Week 48 will depend on the patient's injection regimen, i.e. every 8 weeks or every 12 weeks according to disease activity assessed by the investigator.
Description: To evaluate the short-term effect of brolucizumab on CNV lesion area as measured by Optical Coherence Tomography Angiography (OCT-A) in nAMD patients.
Measure: Percentage change in CNV lesion area measured by OCT-A from Baseline to Week 12 Time: Week 12Description: To evaluate the long-term effects of brolucizumab on Choroidal Neovascularization (CNV) morphology as measured by OCT-A in nAMD patients.
Measure: Percentage change in CNV lesion area measured by OCT-A from Baseline to Week 48 Time: Week 48Description: To evaluate the long-term effects of brolucizumab on Choroidal Neovascularization (CNV) morphology as measured by OCT-A in nAMD patients.
Measure: Change in OCT-A features assessed by qualitative and quantitative criteria from Baseline by visit at Week 12 up to Week 48 Time: Week 48Description: To evaluate the effect of brolucizumab on anatomical parameters as assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Fluorescein Angiography (FA) from Week 12 up to Week 48.
Measure: Change in SD-OCT and FA features assessed by qualitative and quantitative criteria: Central Sub-Field Retinal Thickness (CSFT), sub and/or intraretinal fluid, sub-RPE (Retinal Pigmented Epithelium) fluid from Baseline by visit up to Week 48 Time: Week 48Description: To evaluate the efficacy of brolucizumab up to Week 48 by assessing changes in BCVA.
Measure: Change in Best Corrected Visual Acuity (BCVA) from Baseline up to Week 48 Time: Week 48Description: To estimate the proportion of patients treated at q12w frequency with brolucizumab.
Measure: Proportion of patients who are maintained on an exclusive treatment interval every 12 weeks (q12w) following the loading phase through to Week 48 Time: Week 48Description: To estimate the predictive value of the first q12w cycle for maintenance of q12w treatment with brolucizumab.
Measure: The probability of the first q12w interval for determining successful q12w maintenance at Week 48 Time: Week 48Description: To evaluate the time from last IVT injection in the initiation phase to first visit with no disease activity.
Measure: Time from last Intravitreal (IVT) injection in the initiation phase to first visit with no disease activity. Time: Week 8 until Week 48Description: To describe Patient Reported Outcomes (PROs) collected by auto-evaluation tools.
Measure: Change in self-completed auto evaluation tool from Baseline through to Week 48 Time: Week 48Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss. The safety and efficacy of brolucizumab were assessed in 2 randomized, multicenter, double-masked, active treatment-controlled Phase 3 studies in nAMD patients (the HAWK study (RTH258-C001 [NCT02307682]) and the HARRIER study (RTH258-C002 [NCT02434328]). Accordingly, a new Phase 3b study (TALON, CRTH258A2303) is being conducted to evaluate the efficacy and safety of brolucizumab in a Treat-to-Control (TtC) regimen for the treatment of naïve patients with nAMD. In this TtC regimen, patients receive 3 consecutive injections every 4 weeks and then the injection interval is extended by 4 weeks up to a maximum of a 16-week interval. The decision to extend or reduce the injection interval is taken by the Investigator at each visit based on his/her judgment of disease activity, according to the patient visual and/or anatomic outcomes. If there is no disease activity, the injection interval can be extended by 4 weeks ; if disease activity occurs or recurs, the injection interval should be shortened accordingly by 4 weeks at a time or to a minimal interval of 4 weeks. The injection interval can also be maintained if the Investigator deems that the patient do not benefit from injection interval adjustment. Since all these studies were conducted in a naïve nAMD patient population, no data are available on the efficacy and safety of brolucizumab in pretreated nAMD patients who still present active exudation.
Description: To evaluate the effect of brolucizumab 6 mg on disease control
Measure: Proportion of patients with no disease activity at Week 16 Time: Week 16Description: To evaluate the long term effects of brolucizumab 6 mg on disease control
Measure: Proportion of patients with no disease activity at Week 48 Time: Week 48Description: To evaluate the effect of brolucizumab 6 mg on anatomical parameters
Measure: Change from Baseline in CFST (Central Sub-Field Retinal Thickness) as assessed by OCT (Optical Coherence Tomography) over time up to Week 48 Time: Week 48Description: To evaluate the effect of brolucizumab 6 mg on anatomical parameters
Measure: Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and sub-RPE (Retinal Pigmented Epithelium) fluid as assessed by OCT over time up to Week 48 Time: Week 48Description: To evaluate the effect of brolucizumab 6 mg on anatomical parameters
Measure: Proportion of patients with a dry retina (neither IRF nor SRF) up to Week 48 Time: Week 48Description: To evaluate the durability of brolucizumab 6 mg
Measure: Distribution of the last interval with no disease activity up to Week 48 Time: Week 48Description: To evaluate the durability of brolucizumab 6 mg
Measure: Distribution of the maximal intervals with no disease activity up to Week 48 Time: Week 48Description: To evaluate functional outcomes
Measure: Average change in BCVA (Best-Corrected Visual Acuity) from Baseline up to Week 48 Time: Week 48In 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-upAlphabetical 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