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| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 2 clinical trials
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 48Alphabetical 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