protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03378778 | 2.4.4 | Analysis | 2.4.4 Analysis Descriptive statistics will be used to summarise the sample characteristics and baseline measurements. Chi square test for association will be used to test whether there is any relationship between success rate and different groups. The difference in success rate over a period of time will be analysed us... | [] |
NCT03378778 | 3 | Selection and Withdrawal of Subjects | 3. Selection and Withdrawal of Subjects | [] |
NCT03378778 | 3.1 | Inclusion Criteria | 3.1 Inclusion Criteria - 1) Patients either male or female over the age of 18 (who can consent for themselves) in good general health. - 2) The selected teeth needed to be in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth. - 3) Molar or premolar teeth with suspected ... | [] |
NCT03378778 | 3.2 | Exclusion Criteria | 3.2 Exclusion Criteria - 1) Pregnant women, in view of requirements for radiographs (or if they could possibly be pregnant). To be confirmed by the Medical History Questionnaire. - 2) Patients younger than 18. - 3) Patients unable to give consent. - 4) Teeth with probing periodontal depths greater than 5 mm. - 5) Non-r... | [] |
NCT03378778 | 3.3 | Withdrawal of Subjects | 3.3 Withdrawal of Subjects The participant would be withdrawn from the study if he or she no longer wishes to participate in the study or has relocated and will be unable to attend. Data or tissue, which is not identifiable to the research team, may be retained. Any identifiable data or tissue would be anonymised or di... | [] |
NCT03378778 | 4 | Assessment of Efficacy | 4. Assessment of Efficacy | [] |
NCT03378778 | 4.1 | Efficacy Parameters | 4.1 Efficacy Parameters Parameters used to assess efficacy of the study will depend upon the participant's signs and symptoms, clinical examination and radiographical assessment. | [] |
NCT03378778 | 4.1.1 | Primary Efficacy Parameters | 4.1.1 Primary Efficacy Parameters The primary efficacy parameter will be the success of teeth in relation to the absence of any signs and symptoms, endodontic or restorative failures. | [] |
NCT03378778 | 4.1.2 | Secondary Efficacy Parameters | 4.1.2 Secondary Efficacy Parameters The survival of teeth and or restoration in the oral cavity. | [] |
NCT03378778 | 4.2 | Procedures for Assessing Efficacy Parameters | 4.2 Procedures for Assessing Efficacy Parameters Patients will be recalled after 12 and 24 months for clinical and radiographical assessments. Four examiners other than the operator independently performed evaluation of success or failure. Clinical examination should reveal the absence of the following events which con... | [] |
NCT03378778 | 5 | Assessment of Safety | 5. Assessment of Safety - 5.1 Specification, Timing and Recording of Safety Parameters Measures that will be taken to ensure the subject's safety during the study are the same as with any routine dental procedure. - 5.2 Adverse Event (AE)- Any untoward medical occurrence in a subject to whom a medicinal product has bee... | [] |
NCT03378778 | 6 | Definition of the End of Trial | 6. Definition of the End of Trial The end of trial is after the end of visit five (twenty forth month follow-up). Following that, patients will be reviewed normally either at their GDP or at Guy's Hospital. | [] |
NCT03378778 | 7 | Direct Access to Source Data and Documents | 7. Direct Access to Source Data and Documents The investigators and KCL will permit trial-related monitoring, audits, REC review, and regulatory inspections (where appropriate) by providing direct access to source data and other documents such as patients' case sheets and notes. | [] |
NCT03378778 | 8 | Ethics & Regulatory Approvals | 8. Ethics & Regulatory Approvals The study will be conducted in compliance with the principles of the Declaration of Helsinki and the principles of GCP. Any subsequent protocol amendments will be submitted to the REC, and the REC will be provided with progress reports, and a copy of the Final Study Report. | [] |
NCT03378778 | 9 | Quality Assurance, Data Handling, Publication Policy and Finance | 9. Quality Assurance, Data Handling, Publication Policy and Finance Patients will be allocated a unique identification number. The Principal Investigator will maintain a database of the patient's personal data, clinical notes and treatment records. This will be stored in the office of the Chief Investigator Prof France... | [] |
NCT03378778 | 10 | References | 10. References - 1. Schilder, H., Filling root canals in three dimensions. Dent Clin North Am, 1967: p. 723–44. - 2. Schilder, H., Cleaning and shaping the root canal. Dent Clin North Am, 1974. 18: p. 269-96. - 3. Hülsmann, M., O.A. Peters, and P.M.H. Dummer, Mechanical preparation of root canals: shaping goals, techni... | [] |
NCT03386474 | 1 | Introduction | 1 Introduction | [] |
NCT03386474 | 1.1 | Background | 1.1 Background Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people affecting 10%-13% of individuals over the age of 65 in North America, Europe, and Australia ([Kawasaki 2010, Rein 2009, Smith 2001\)](#page-48-0). Genetic, environmental and health factors play an important role i... | [
"Brolucizumab development program in nAMD"
] |
NCT03386474 | 1.2 | Purpose | 1.2 Purpose The purpose of this study is to collect information on safety and efficacy of the brolucizumab 6 mg drug product intended for commercialization in patients with nAMD to support comparability to the brolucizumab 6 mg drug product used in Phase III clinical studies. | [] |
NCT03386474 | 2 | Study objectives and endpoints | 2 Study objectives and endpoints | [] |
NCT03386474 | 2.1 | Objectives and related endpoints | 2.1 Objectives and related endpoints
Table 2-1 Objectives and related endpoints
Objective(s) Endpoint(s)
To collect data on safety and efficacy of the brolucizumab 6 mg drug product intended for commercialization in patients with nAMD previously treated in CRTH258A2301 study to support comparability to the brolucizu... | [
"Table 2-1 Objectives and related endpoints",
"Objective(s) Endpoint(s)",
"To collect data on safety and efficacy of the brolucizumab 6 mg drug product intended for commercialization in patients with nAMD previously treated in CRTH258A2301 study to support comparability to the brolucizumab 6 mg drug product use... |
NCT03386474 | 3 | Investigational plan | 3 Investigational plan | [] |
NCT03386474 | 3.1 | Study design | 3.1 Study design This is a double-masked, multicenter, two-arm extension study [\(Figure 3-1\)](#page-14-0). Subgroup of patients who have completed the 96-week core study CRTH258A2301, regardless of the treatment group (brolucizumab 3 mg, brolucizumab 6 mg or aflibercept 2 mg) are eligible for inclusion in the extensi... | [
"Baseline visit"
] |
NCT03386474 | 3.2 | Rationale for study design | 3.2 Rationale for study design This multicenter extension study is designed to collect data on safety and efficacy of the brolucizumab 6 mg drug product intended for commercialization in nAMD patients. Enrollment of patients who were treated with aflibercept in the core study ensures that the conduct of both studies (c... | [] |
NCT03386474 | 3.3 | Rationale for dose/regimen, route of administration and duration of treatment | 3.3 Rationale for dose/regimen, route of administration and duration of treatment Analysis of the data up to Week 48 from the ongoing CRTH258A2301 and CRTH258A2302 studies demonstrated non-inferiority in BCVA for brolucizumab as compared to aflibercept while the overall ocular and non-ocular (systemic) adverse events w... | [] |
NCT03386474 | 3.4 | Rationale for choice of comparator | 3.4 Rationale for choice of comparator In the CRTH258A2301 core study, efficacy and safety of brolucizumab was compared with aflibercept. This is an extension to the CRTH258A2301 study and patients who were randomized to the aflibercept arm in the core will continue receiving aflibercept in order to ensure that both st... | [] |
NCT03386474 | 3.5 | Purpose and timing of interim analyses/design adaptations | 3.5 Purpose and timing of interim analyses/design adaptations An interim analysis might be conducted when 50 patients are treated with brolucizumab 6 mg for 6 months to support a brolucizumab Biologic License Application submission at the earliest possible time point, which is currently planned for Dec 2018. | [] |
NCT03386474 | 3.6 | Risks and benefits | 3.6 Risks and benefits Brolucizumab is an inhibitor of VEGF with a mechanism of action similar to ranibizumab with a smaller molecular size (26 kDa and 48 kDa, respectively). Comprehensive analytical drug substance comparability studies and ongoing analytical testing of the drug product, demonstrate comparability betwe... | [] |
NCT03386474 | 4 | Population | 4 Population The study population will consist of male and female patients who have completed the core study (CRTH258A2301). Approximately 75 to 100 patients are expected to be enrolled in approximately 70 centers in the United States. | [] |
NCT03386474 | 4.1 | Inclusion criteria | 4.1 Inclusion criteria Patients eligible for inclusion in this study must fulfill all of the following criteria: - 1. Written informed consent must be obtained before any assessment is performed. - 2. The patient completed the core study, as defined by providing assessments at the Visit 26/ Week 96, within ≤ 12 weeks o... | [] |
NCT03386474 | 4.2 | Exclusion criteria | 4.2 Exclusion criteria Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients. - 1. Patient discontinued the treatment or the... | [] |
NCT03386474 | 5 | Treatment | 5 Treatment | [] |
NCT03386474 | 5.1 | Study treatment | 5.1 Study treatment | [] |
NCT03386474 | 5.1.1 | Investigational and control drugs | 5.1.1 Investigational and control drugs - Brolucizumab 6 mg - Aflibercept 2 mg Brolucizumab 6 mg drug product intended for commercialization is used in this study. Changes to the excipients within the drug product were made, namely change to the pH (increase from app. 6.8 to app. 7.2) and change to the polysorbate conc... | [] |
NCT03386474 | 5.1.2 | Additional treatment | 5.1.2 Additional treatment No additional treatment beyond investigational drug is included in this trial. | [] |
NCT03386474 | 5.2 | Treatment arms | 5.2 Treatment arms Depending on the treatment arm assignment in the core study, patients will be assigned at Visit 1/ Baseline to one of the two treatment arms: - Arm 1: brolucizumab 6 mg patients treated with brolucizumab 3 mg or brolucizumab 6 mg in the core study. All patients will receive IVT injection at Baseline ... | [] |
NCT03386474 | 5.3 | Treatment assignment and randomization | 5.3 Treatment assignment and randomization At Visit 1/ Baseline, the investigator or his/her delegate will access the IRT after confirming that the patient fulfills all the inclusion/exclusion criteria. IRT will specify a unique medication number for the package of study drug to be dispensed to the patient. | [] |
NCT03386474 | 5.4 | Treatment masking | 5.4 Treatment masking This is a double-masked study. The patients, investigators and site staff (except for the unmasked site personnel and unmasked injecting physician), Sponsor clinical site management (except for those who have been delegated responsibility for working with the study drug), the statisticians and cli... | [
"VA examiner (masked to the treatment assignment)"
] |
NCT03386474 | 5.5 | Treating the patient | 5.5 Treating the patient Sponsor qualified medical personnel will be readily available to advise on trial related medical questions or problems. | [] |
NCT03386474 | 5.5.1 | Patient numbering | 5.5.1 Patient numbering Each patient is uniquely identified by a Subject Number assigned by Novartis. The subject number is composed of a site number and a sequential number. The same Subject Number assigned to the patient in the core study will be used in the extension study. Upon signing the informed consent form, th... | [] |
NCT03386474 | 5.5.2 | Dispensing the study drug | 5.5.2 Dispensing the study drug Each study site will be supplied with investigational and control drug in packaging of identical appearance. The study drug packaging has a 2-part label. A unique medication number is printed on each part of this label. Investigator staff will identify the study drug package(s) to dispen... | [] |
NCT03386474 | 5.5.3 | Handling of study and additional treatment | 5.5.3 Handling of study and additional treatment | [] |
NCT03386474 | 5.5.3.1 | Handling of study treatment | 5.5.3.1 Handling of study treatment Study treatment must be received by a designated person at the study site, handled and stored safely and properly, and kept in a secured location to which only the investigator and designees have access. Upon receipt, all study treatment must be stored according to the instructions s... | [] |
NCT03386474 | 5.5.3.2 | Handling of additional treatment | 5.5.3.2 Handling of additional treatment Not applicable. | [] |
NCT03386474 | 5.5.4 | Instructions for prescribing and taking study treatment | 5.5.4 Instructions for prescribing and taking study treatment Brolucizumab will be administered via intravitreal injection (in accordance with supplied proposed commercial instructions for use as described in the Operational Manual) at Visit 1/ Baseline, Visit 3/ Week 8, and, depending on the disease activity as assess... | [
"Disease activity assessment",
"Intravitreal injection",
"Sham injection"
] |
NCT03386474 | 5.5.5 | Permitted dose adjustments and interruptions of study treatment | 5.5.5 Permitted dose adjustments and interruptions of study treatment Investigational treatment dose adjustments are not permitted. If based on investigator's judgement, safe administration of the study drug is contraindicated (e.g., patient experiences an AE), investigational treatment can be administered within 7 day... | [] |
NCT03386474 | 5.5.6 | Rescue medication | 5.5.6 Rescue medication Rescue medication in the study eye is not permitted in this study. Treatment with medications approved for nAMD is permitted in the fellow eye at the discretion of the investigator and in accordance with the administration procedures established at the study center. Such treatment must be record... | [] |
NCT03386474 | 5.5.7 | Concomitant medication | 5.5.7 Concomitant medication The investigator must instruct the patient to notify the study site about any new medications he/she takes after the patient was enrolled into the study. All medications, procedures and significant non-drug therapies (including physical therapy and blood transfusions) administered after the... | [] |
NCT03386474 | 5.5.8 | Prohibited medication | 5.5.8 Prohibited medication Use of the treatments displayed in the below table is NOT allowed after the start of investigational drug. Table 5-1 Prohibited medication | Medication | Prohibition period | Action taken | |-----------------------------------------------------------------------------------------------------... | [] |
NCT03386474 | 5.5.9 | Emergency breaking of assigned treatment code | 5.5.9 Emergency breaking of assigned treatment code Emergency code breaks must only be undertaken when it is required to treat the patient safely. Most often, study treatment discontinuation and knowledge of the possible treatment assignments are sufficient to treat a study patient who presents with an emergency condit... | [] |
NCT03386474 | 5.6 | Study completion and discontinuation | 5.6 Study completion and discontinuation | [] |
NCT03386474 | 5.6.1 | Study completion and post-study treatment | 5.6.1 Study completion and post-study treatment A patient will be considered to have completed the study when the patient has completed the last visit planned in the protocol. The investigator and/or referring physician will recommend the appropriate follow-up medical care, if needed, for all patients who completed the... | [] |
NCT03386474 | 5.6.2 | Discontinuation of study treatment | 5.6.2 Discontinuation of study treatment Discontinuation of study treatment for a patient occurs when study drug is stopped earlier than the protocol planned duration, and can be initiated by either the patient or the investigator. The investigator must discontinue study treatment for a given patient if, on balance, he... | [] |
NCT03386474 | 5.6.3 | Withdrawal of informed consent | 5.6.3 Withdrawal of informed consent Patients may voluntarily withdraw consent to participate in the study for any reason at any time. Withdrawal of consent from the study is defined as when a patient: - Does not want to participate in the study anymore - and - Does not want any further visits or assessments and - Does... | [] |
NCT03386474 | 5.6.4 | Loss to follow-up | 5.6.4 Loss to follow-up For subjects whose status is unclear because they fail to appear for study visits without stating an intention to discontinue or withdraw, the investigator must show "due diligence" by documenting in the source documents steps taken to contact the subject, e.g. dates of telephone calls, register... | [] |
NCT03386474 | 5.6.5 | Early study termination by the sponsor | 5.6.5 Early study termination by the sponsor The study can be terminated by Novartis at any time for any reason. This may include reasons related to the benefit risk assessment of participating in the study, practical reasons, or for regulatory or medical reasons (including slow enrolment). Should this be necessary, th... | [] |
NCT03386474 | 6 | Visit schedule and assessments | 6 Visit schedule and assessments [Table 6-1](#page-27-0) lists all of the assessments and indicates with an "x" when the visits are performed. Patients must be seen for all visits on the designated day, or as close to it as possible. Patients with missed visits should have them re-scheduled as soon as possible. Missed ... | [] |
NCT03386474 | 6.1 | Information to be collected on screening failures | 6.1 Information to be collected on screening failures There is no separate screening visit/ screening period planned in this study. Patient's eligibility will be assessed at Visit 1/ Baseline. All patients who have signed informed consent but not entered into the extension study will be considered screen failures. The ... | [] |
NCT03386474 | 6.2 | Patient demographics/other baseline characteristics | 6.2 Patient demographics/other baseline characteristics Patient demographic and baseline characteristic data to be collected on all patients include: age, sex, race, ethnicity, and Japanese ancestry, study eye, iris color and history of primary diagnosis. With the exception of age, entries in the extension study databa... | [] |
NCT03386474 | 6.3 | Treatment exposure and compliance | 6.3 Treatment exposure and compliance Every time the study treatment is to be administered, IRT needs to be accessed for the medication (kit) number. The date and time of all study treatment injections administered during the study and any deviations from the protocol treatment schedule will be recorded in the CRF Dosi... | [] |
NCT03386474 | 6.4 | Efficacy | 6.4 Efficacy Efficacy assessment will include BCVA with ETDRS-like chart at 4 meters and Optical Coherence Tomography (OCT). The BCVA will be conducted in both eyes at every study visit. BCVA testing should precede any examination requiring administration of eye drops to dilate the eye or any examination requiring cont... | [] |
NCT03386474 | 6.4.1 | Visual acuity assessment | 6.4.1 Visual acuity assessment Best-corrected visual acuity will be tested at all study visits in a sitting position using the ETDRS visual acuity testing protocol at an initial testing distance of 4 meters. If it is not possible to perform a subjective refraction or VA testing at 4 meters because VA is too poor for th... | [] |
NCT03386474 | 6.4.2 | Optical Coherence Tomography | 6.4.2 Optical Coherence Tomography Optical Coherence Tomography will be assessed in the study eye at every study visit and in both eyes at Visit 1/ Baseline and Visit 7/ EoS. The assessment will be performed by qualified technician or investigator prior to study drug administration. The investigator should evaluate the... | [] |
NCT03386474 | 6.4.3 | Appropriateness of efficacy assessments | 6.4.3 Appropriateness of efficacy assessments BCVA and OCT are standard assessments for this indication and patient population, and well established in the field of ophthalmologic clinical research. | [] |
NCT03386474 | 6.5 | Safety | 6.5 Safety Safety assessments will be done based on ophthalmic examinations, color fundus photography, vital signs, laboratory results and the type, frequency, and severity of AEs. Safety assessments are performed according to the schedule in [Table 6-1](#page-27-0). | [] |
NCT03386474 | 6.5.1 | Ophthalmic examination | 6.5.1 Ophthalmic examination The ophthalmic exam will be performed in the study eye at every study visit and in both eyes at Visit 1/ Baseline and Visit 7/ EoS. If study visit assessments and a corresponding treatment occur on separate days, ophthalmic examinations should be performed as safety check-up before treatmen... | [] |
NCT03386474 | 6.5.2 | Color Fundus Photography | 6.5.2 Color Fundus Photography Color Fundus (CF) photography will be assessed in the study eye at Visit 1/ Baseline and Visit 7/ EoS. The assessment will be performed by qualified technician or investigator prior to study drug administration. The investigator should evaluate the images according to their standard clini... | [] |
NCT03386474 | 6.5.3 | Vital signs | 6.5.3 Vital signs Vital signs include blood pressure (BP) and pulse measurements. After the patient has been sitting for approximately five minutes (in case of 'white coat syndrome' the patient should be given sufficient time to calm down), with back supported and both feet placed on the floor, systolic and diastolic B... | [] |
NCT03386474 | 6.5.4 | Laboratory evaluations | 6.5.4 Laboratory evaluations Local or central laboratory will be used for analysis of all specimens collected at the visits indicated in [Table 6-1.](#page-27-0) The results of the laboratory examinations should be recorded in the source documents only. Any clinically significant abnormalities will be recorded on the a... | [] |
NCT03386474 | 6.5.4.1 | Hematology | 6.5.4.1 Hematology Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count with differential (absolute and percentage of neutrophils, lymphocytes, monocytes, eosinophils, and basophils), and quantitative platelet count will be measured. | [] |
NCT03386474 | 6.5.4.2 | Clinical chemistry | 6.5.4.2 Clinical chemistry Blood urea nitrogen (BUN), serum creatine, BUN/Creatinine ratio, uric acid, cholesterol, triglycerides, albumin, total globulin, albumin/globulin (A/G) ratio, total serum iron, total protein, serum electrolytes (sodium, potassium, bicarbonate, chloride, calcium, magnesium), phosphate, glucose... | [] |
NCT03386474 | 6.5.4.3 | Urinalysis | 6.5.4.3 Urinalysis Specific gravity, pH, color, glucose, blood, ketones, bilirubin, and microscopic examination (WBC, RBC, epithelial cells, bacteria, mucus, casts, crystals) will be performed. | [] |
NCT03386474 | 6.5.5 | Pregnancy and assessments of fertility | 6.5.5 Pregnancy and assessments of fertility All pre-menopausal women who are not surgically sterile will have pregnancy testing. Additional pregnancy testing might be performed if requested by local requirements. A urine pregnancy test will be conducted for all women of childbearing potential to assess pregnancy befor... | [] |
NCT03386474 | 6.5.6 | Appropriateness of safety measurements | 6.5.6 Appropriateness of safety measurements The safety assessments selected are standard for this indication/patient population. | [] |
NCT03386474 | 6.6 | Other assessments | 6.6 Other assessments | [] |
NCT03386474 | 6.6.1 | Anti-drug antibodies (immunogenicity) | 6.6.1 Anti-drug antibodies (immunogenicity) Collection of blood for ADA assessment will be performed at Visit 1/ Baseline, Visit 3/ Week 8, Visit 5/ Week 16 and Visit 7/ EoS. Blood draws should take place prior to the study drug administration. Further details on sample collection, numbering, processing, storage and sh... | [] |
NCT03386474 | 7 | Safety monitoring | 7 Safety monitoring | [] |
NCT03386474 | 7.1 | Adverse events | 7.1 Adverse events An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of stu... | [] |
NCT03386474 | 7.2 | Serious adverse events | 7.2 Serious adverse events | [] |
NCT03386474 | 7.2.1 | Definition of SAE | 7.2.1 Definition of SAE An SAE is defined as any adverse event [appearance of (or worsening of any pre-existing)] undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: - is fatal or life-threatening - results in persistent or significant disability/incapacity - constitu... | [] |
NCT03386474 | 7.2.2 | SAE reporting | 7.2.2 SAE reporting To ensure patient safety, every SAE, regardless of causality, occurring after the patient has provided informed consent and until 30 days after the last study visit / following the last administration of study treatment whichever is later must be reported to Novartis safety within 24 hours of learni... | [] |
NCT03386474 | 7.3 | Liver safety monitoring | 7.3 Liver safety monitoring Due to the extremely low systemic exposure following IVT administration and the lack of systemic toxicity following repeated IVT injections of brolucizumab up to 6 mg observed in pre-clinical studies, no clinical liver toxicity studies were considered necessary. In addition, clinical experie... | [] |
NCT03386474 | 7.4 | Renal safety monitoring | 7.4 Renal safety monitoring Due to the extremely low systemic exposure following IVT administration and the lack of systemic toxicity following repeated IVT injections of brolucizumab up to 6 mg observed in pre-clinical studies, no clinical renal toxicity studies were considered necessary. In addition, clinical experie... | [] |
NCT03386474 | 7.5 | Reporting of study treatment errors | 7.5 Reporting of study treatment errors Medication errors are unintentional errors in the prescribing, dispensing, administration or monitoring of a medicine while under the control of a healthcare professional, patient or consumer (EMA definition). Misuse/ abuse is not applicable to this study as IVT injection is perf... | [] |
NCT03386474 | 7.6 | Pregnancy reporting | 7.6 Pregnancy reporting To ensure patient safety, each pregnancy occurring after signing the informed consent must be reported to Novartis within 24 hours of learning of its occurrence. The pregnancy should be followed up to determine outcome, including spontaneous or voluntary termination, details of the birth, and th... | [] |
NCT03386474 | 8 | Data review and database management | 8 Data review and database management | [] |
NCT03386474 | 8.1 | Site monitoring | 8.1 Site monitoring Before study initiation, at a site initiation visit or at an investigator's meeting, a Novartis representative will review the protocol and data capture requirements (i.e. eSource DDE or eCRFs) with the investigators and their staff. During the study, Novartis employs several methods of ensuring pro... | [] |
NCT03386474 | 8.2 | Data collection | 8.2 Data collection Designated investigator staff will enter the data required by the protocol into the Electronic Case Report Forms (eCRFs) using fully validated secure web-enabled software that conforms to US CFR 21 Part 11 requirements. Designated investigator site staff will not be given access to the system until ... | [] |
NCT03386474 | 8.3 | Database management and quality control | 8.3 Database management and quality control Novartis personnel (or designated CRO) will review the data entered by investigational staff for completeness and accuracy. Electronic data queries stating the nature of the problem and requesting clarification will be created for discrepancies and missing values and sent to ... | [] |
NCT03386474 | 8.4 | Data Monitoring Committee | 8.4 Data Monitoring Committee Not required. | [] |
NCT03386474 | 8.5 | Adjudication Committee | 8.5 Adjudication Committee Not required. | [] |
NCT03386474 | 9 | Data analysis | 9 Data analysis The assessment of the brolucizumab outcome of this study will be based on a within-patient comparison with corresponding core-study data serving as reference. Neither the patient selection process nor the expected sample sizes support a valid comparison between aflibercept and brolucizumab. Analyses of ... | [] |
NCT03386474 | 9.1 | Analysis sets | 9.1 Analysis sets All analyses will be performed on the Extension Safety Set, being defined as all patients who enter this extension study and receive at least one injection of study treatment in this extension study. | [] |
NCT03386474 | 9.2 | Patient demographics and other baseline characteristics | 9.2 Patient demographics and other baseline characteristics | [] |
NCT03386474 | 9.2.1 | Demographics | 9.2.1 Demographics Age (< 50, 50-64, 65-74, 75-84, ≥ 85 years), gender, ethnicity and Japanese ancestry will be summarized using the number of observations, the number of observations for each category and the corresponding frequency and percent. Age will also be summarized as a continuous variable. | [] |
NCT03386474 | 9.2.2 | Baseline characteristics | 9.2.2 Baseline characteristics The summary of baseline ocular characteristics will be presented separately for the study eye and the fellow eye and will include: primary diagnosis of AMD, time since diagnosis of AMD (months), whether AMD is unilateral or bilateral, BCVA (both as a continuous variable and using categori... | [] |
NCT03386474 | 9.2.3 | Medical history | 9.2.3 Medical history Medical history (ocular and non-ocular) will be described based on: - the medical history as documented in the core study - all treatment emergent SAEs/AEs as documented in the core study - all new medical conditions occurring between the end of core study and enrollment into the extension study T... | [] |
NCT03386474 | 9.3 | Treatments | 9.3 Treatments | [] |
NCT03386474 | 9.3.1 | Study treatment exposure | 9.3.1 Study treatment exposure The extent of exposure to study treatment is calculated using the number of injections. The following summaries will be presented: - Overall number of treatments will be presented separately (active and sham, active only, sham only) during the following time periods: - Extension baseline ... | [] |
NCT03386474 | 9.3.2 | Prior medications | 9.3.2 Prior medications Prior medications (ocular and non-ocular) will be summarized using number and percent of patients by ATC class and preferred term according to the WHO Drug reference list dictionary. Prior medications are those that have a start date prior to the date of the first injection of study treatment in... | [] |
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