protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT01975389 | 3.4.1 | Executive Committee | 3.4.1. Executive Committee An Executive Committee will be responsible for providing overall guidance to Pfizer on the study protocol. This will include evaluation of the scientific merit of proposed sub-studies, execution of the trial, review of recommendations from the Data Monitoring Committee (DMC) and oversight of ... | [] |
NCT01975389 | 3.4.2 | Adjudication Committee | 3.4.2. Adjudication Committee An Adjudication Committee will perform a blinded review of all potential primary, secondary, and tertiary endpoints (as specified in the Adjudication Committee Charter) to confirm that the data support the endpoint designation. The Adjudication Committee Charter describes the Adjudication ... | [] |
NCT01975389 | 3.4.3 | Data Monitoring Committee | 3.4.3. Data Monitoring Committee Subject safety will be monitored by an independent data monitoring committee (DMC). An independent statistical data analysis center will provide analyses to the DMC according to the DMC charter. In addition, the DMC will review the interim analysis for clinical benefit. The same indepen... | [] |
NCT01975389 | 3.4.4 | Steering Committee | 3.4.4. Steering Committee The Steering Committee comprises medical representatives from each country of study operations and will oversee recruitment, retention and quality issues within the country. This committee will work jointly with the Executive Committee, to ensure that operational issues are effectively address... | [] |
NCT01975389 | 3.4.5 | Joint Leadership/Operations Committee | 3.4.5. Joint Leadership/Operations Committee The Joint Leadership/Operations Committee will be responsible for the operational aspects of study execution, global site initiation and monitoring, recruitment and data quality issues across the different academic and clinical research organizations. It will make recommenda... | [] |
NCT01975389 | 4 | SUBJECT SELECTION | 4. SUBJECT SELECTION This study can fulfill its objectives only if appropriate subjects are enrolled and followed throughout the completion of the trial irrespective of whether they are maintained on IP. All efforts should be made to follow all subjects for the entire duration of the study. Importantly, discontinuation... | [] |
NCT01975389 | 4.1 | Inclusion Criteria | 4.1. Inclusion Criteria Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team, before subjects are included in the study. Appropriately qualified members of the investigator's study team are defined in the study site's delegation of authority log. A ... | [
"1. Informed Consent",
"2. Compliance",
"3. Age"
] |
NCT01975389 | 4 | Acceptance of administration of investigational product | 4. Acceptance of administration of investigational product Subjects must be willing and able to self-administer or be administered sub-cutaneous injections of IP. | [] |
NCT01975389 | 5 | Requirements for background lipid lowering treatment | 5. Requirements for background lipid lowering treatment There should be no plans at the time of pre-screening and randomization to modify the dose of statin for the duration of the trial. Unless the background lipid lowering treatment exceptions described below are met, subjects must be treated with one of the followin... | [
"Background lipid lowering treatment exceptions",
"Lower doses of statins due to partial statin intolerance",
"Regulatory limitations",
"Alternative statins",
"No background statin therapy"
] |
NCT01975389 | 6 | Qualifying cardiovascular disease risk | 6. Qualifying cardiovascular disease risk Qualifying cardiovascular disease (CVD) risk must be documented by supporting source documentation such as, but not limited to, copies of a hospital discharge summary, copies of medical records, or other documents that can be used to confirm the qualifying CVD risk event or dia... | [
"a. Myocardial infarction",
"b. Ischemic stroke",
"c. Coronary artery revascularization",
"d. Non-coronary arterial revascularization",
"e. CVD risk conditions and CVD risk factors",
"CVD Risk Conditions",
"Diabetes",
"Peripheral vascular disease",
"Chronic kidney disease",
"Conditions of elevated... |
NCT01975389 | 7 | Qualifying lipid levels (LDL-C or non-HDL-C) | 7. Qualifying lipid levels (LDL-C or non-HDL-C) Subjects must have a direct LDL-C measurement of 100 mg/dL (2.59 mmol/L) or non-HDL-C 130 mg/dL (3.36 mmol/L) at the pre-screening visit, to qualify for inclusion in the study. The lipid values collected at Visit 3 are not used to determine qualification. | [] |
NCT01975389 | 8 | Contraception requirements | 8. Contraception requirements Male subjects able to father children and female subjects of childbearing potential, who (with their partners) are at risk for pregnancy, or male subjects with pregnant partners who are sexually active, must agree to use a highly effective method of contraception throughout the study and f... | [
"4.2. Exclusion Criteria",
"1. Personnel involved in the conduct of the study",
"2. Exclusionary prior CV events or planned revascularization procedures",
"3. Participation in prior clinical research studies",
"4. Other exclusionary conditions",
"5. Childbearing potential and/or breast feeding",
"6. Lat... |
NCT01975389 | 8 | Severe congestive heart failure | 8. Severe congestive heart failure Congestive heart failure of New York Heart Association (NYHA) Class IV, or if there is prior documentation of left ventricular ejection fraction (LVEF) of <25%, measured by imaging. For subjects who have had serial assessments of LVEF, only the most recent study is used for the purpos... | [] |
NCT01975389 | 9 | Dialysis | 9. Dialysis Potential subjects with end stage renal disease on dialysis. | [] |
NCT01975389 | 10 | Chronic renal insufficiency | 10. Chronic renal insufficiency Potential subjects with an eGFR of 2 by MDRD formula at Visit 1. | [] |
NCT01975389 | 11 | Hypertension | 11. Hypertension Poorly controlled hypertension at any screening visit or at randomization, defined as the average of two systolic blood pressure (BP) measurements >180 mmHg or the average of two diastolic BP measurements >110 mmHg even with treatment. Subjects who have hypertension and are controlled on stable doses o... | [] |
NCT01975389 | 12 | Cerebral hemorrhage risk | 12. Cerebral hemorrhage risk A prior history of hemorrhagic stroke or lacunar infarct resulting in a stroke (a lacunar infarct which was seen with cerebral imaging is not exclusionary in the absence of a clinical stroke). A prior ischemic stroke which resulted in hemorrhagic transformation is not exclusionary. | [] |
NCT01975389 | 13 | Tissue donation | 13. Tissue donation Plans to donate any tissues (eg, blood, sperm, or other tissues, including participating in in vitro fertilization) during the study. | [] |
NCT01975389 | 14 | Substance abuse | 14. Substance abuse Current history of alcoholism or drug addiction according to diagnostic and statistical manual of mental disorders (DSM) IV criteria within 12 months prior to screening. Use of any recreational drugs within 12 months prior to screening. | [] |
NCT01975389 | 15 | Human immunodeficiency virus | 15. Human immunodeficiency virus Medical history of positive testing for human immunodeficiency virus (HIV). | [] |
NCT01975389 | 16 | Prior or anticipated exposure to a PCSK9 inhibitor | 16. Prior or anticipated exposure to a PCSK9 inhibitor Subjects with prior exposure to bococizumab or other PCSK9 inhibitors; Subjects who, in the opinion of the investigator, are likely to be treated with a marketed PCSK9 inhibitor at any time during the conduct of the study. | [] |
NCT01975389 | 17 | Depression | 17. Depression If the subject's Patient Health Questionnaire (PHQ-9) score is 15 or there is a positive score in question 9 [\(Section 7.3.2](#page-101-2)), the subject should be excluded from participation, the subject's primary care physician (PCP) should be informed, and the subject should be referred to a mental he... | [] |
NCT01975389 | 18 | Hypersensitivity to monoclonal antibodies | 18. Hypersensitivity to monoclonal antibodies History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (immunoglobulin G [IgG] protein) or molecules made of components of monoclonal antibodies (eg, Enbrel which contains the fragment crystallizable [Fc] portion of an antibody or ... | [] |
NCT01975389 | 19 | Hepatitis | 19. Hepatitis
Hepatitis B Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc), or tests indicative of present or prior infection. NOTE: If a subject tests negative for HBsAg, but positive for anti-HBc, the subject would be considered eligible only if the subject tests positive for anti... | [
"Hepatitis B",
"Hepatitis C"
] |
NCT01975389 | 20 | Creatine kinase elevations | 20. Creatine kinase elevations Creatine kinase (CK) 3.0 x upper limit of normal (ULN) at Visit 1. A measurement 3.0 x ULN may be repeated once, no later than Visit 2, and if <3.0 x ULN the subject is eligible. | [] |
NCT01975389 | 21 | Amino transferase elevation | 21. Amino transferase elevation Alanine amino transferase (ALT) or aspartate amino transferase (AST) >2 x ULN, at Visit 1. These labs may be repeated once for values >2 x ULN, no later than Visit 2, and if 2 x ULN the subject is eligible. | [] |
NCT01975389 | 22 | Bilirubin elevation | 22. Bilirubin elevation Direct bilirubin >1.5 X ULN, at Visit 1. This may be repeated once for values >1.5 X ULN, no later than Visit 2, and if 1.5 x ULN the subject is eligible. | [] |
NCT01975389 | 23 | Malignancy | 23. Malignancy Subjects with cancer who are actively receiving chemotherapy. Potential subjects with a prior history of malignancy should have thorough documentation of the malignancy type and the extent of disease. Potential subjects considered at high risk of recurrence or the development of metastatic disease within... | [] |
NCT01975389 | 24 | Gastric bypass surgery | 24. Gastric bypass surgery Planned or previous gastric bypass surgery.
4.3. Randomization Criteria Subjects will be randomized into the trial upon satisfactory completion of the run-in period if they have demonstrated 100% compliance with all injections of placebo and satisfied all subject selection criteria ([Section... | [
"4.3. Randomization Criteria",
"4.4. Life Style Guidelines",
"4.4.1. Nutritional Counseling",
"4.4.2. Contraception",
"4.5. Sponsor Qualified Medical Personnel",
"5. STUDY TREATMENTS",
"5.1. Allocation to Treatment",
"5.1.1. Interactive Response Technology Registration",
"5.1.2. Visit 0, Pre-screeni... |
NCT01975389 | A | diagnosis of definite Familial Hypercholesterolemia (FH) requires: | A diagnosis of definite Familial Hypercholesterolemia (FH) requires: Cholesterol above 290 mg/dL (7.5 mmol/l) or LDL cholesterol above 189 mg/dL (4.9 mmol/l) in an adult.
PLUS Tendon xanthomas in patient or a 1st degree relative (parent, sibling, child), or in a 2nd degree relative (grandparent, uncle, aunt). OR DNA-b... | [
"PLUS"
] |
NCT01975389 | A | diagnosis of possible FH requires: | A diagnosis of possible FH requires: Cholesterol above 290 mg/dL (7.5 mmol/l) or LDL cholesterol above 189 mg/dL (4.9 mmol/l) in an adult.
PLUS Family history of myocardial infarction (MI): Before 50 years in a 2nd degree relative or below age 60 in a 1st degree relative. OR Family history of raised total cholesterol:... | [
"PLUS",
"Appendix 3. Hepatitis B Assessment",
"Appendix 4. Clinical Endpoints",
"Cardiovascular Death",
"Myocardial Infarction",
"Hospitalization for unstable angina needing urgent revascularization",
"Coronary revascularization",
"Stroke",
"Arterial revascularizations",
"Hospitalization for unsta... |
NCT02087085 | 1 | Background and Clinical Rationale | 1 Background and Clinical Rationale Age-related macular degeneration (AMD) is the leading cause of legal blindness in persons over the age of 65 years ([Friedman et al, 2004; Klein et al, 2006; Chakravarthy et al, 2007](#page-65-0)). Vision loss with this disease is attributed in large part to the advanced stages of th... | [] |
NCT02087085 | 2 | Study Objectives and Clinical Hypotheses | 2 Study Objectives and Clinical Hypotheses | [] |
NCT02087085 | 2.1 | Study Objectives | 2.1 Study Objectives The study objectives are to assess: (1) the safety of the treatment; (2) the effects of treatment on the mean change in atrophic lesion area quantified from FAF images; (3) the effects of treatment on the mean change in low luminance BCVA; (4) the effects of treatment on the mean change in standard... | [] |
NCT02087085 | 2.2 | Clinical Hypotheses | 2.2 Clinical Hypotheses The clinical hypotheses are that: - Brimo DDS is safe and well tolerated with repeated intravitreal administration in patients with GA secondary to AMD as assessed by the incidence of adverse events - Brimo DDS is more effective than Sham treatment in slowing the growth of atrophic lesion area a... | [] |
NCT02087085 | 3 | Study Design | 3 Study Design This is a multicenter, double-masked, randomized, Sham treatment-controlled, 30-month phase 2b study designed to evaluate the safety and efficacy of Brimo DDS in patients with GA secondary to AMD. Patients will be randomized in a 1:1 ratio to receive 400 µg Brimo DDS, administered by intravitreal injecti... | [] |
NCT02087085 | 3.1 | Data Review Committee | 3.1 Data Review Committee A Data Review Committee (DRC) consisting of physicians and trained study personnel, in addition to ad hoc internal/external experts, will assess study treatment effects throughout the study; these assessments will include a review of unmasked safety data and biodegradation of the implant to de... | [] |
NCT02087085 | 4 | Study Population and Entry Criteria | 4 Study Population and Entry Criteria | [] |
NCT02087085 | 4.1 | Number of Patients | 4.1 Number of Patients Approximately 300 patients (150 per treatment group) will be enrolled in the study at approximately 40 sites. Two hundred forty patients are expected to reach Month 24 for the primary endpoint assessment. The anticipated dropout rate is 20%. | [] |
NCT02087085 | 4.2 | Study Population Characteristics | 4.2 Study Population Characteristics To avoid selection bias, the investigator should ensure that all persons who meet the following inclusion and exclusion criteria are offered enrollment in the study. To ensure that the study population will be representative of all eligible patients, no additional exclusions can be ... | [] |
NCT02087085 | 4.3 | Inclusion Criteria | 4.3 Inclusion Criteria The following are requirements for entry into the study:
General Criteria: 1. Male or female patients 55 years of age or older as assessed at Screening Visit 1  The Study Eye must have:  fundus photography and/or SD-OCT at Screening Visit 1 and confi... | [
"General Criteria:",
"The Fellow Eye must have:"
] |
NCT02087085 | 4.4 | Exclusion Criteria | 4.4 Exclusion Criteria The following are criteria for exclusion from participating in the study:
General Criteria:   - 10. History or evidence of the following surgeries/procedures in the study eye as assessed at Screening Visit 1, including: - a. Submacular surgery or o... | [
"General Criteria:"
] |
NCT02087085 | 4.5.1 | Permissible Medications/Treatments | 4.5.1 Permissible Medications/Treatments Therapy considered necessary for the patient's welfare may be given at the discretion of the investigator. All medications and procedures should be recorded in the electronic case report form (eCRF). If the permissibility of a specific medication/treatment is in question, please... | [] |
NCT02087085 | 4.5.2 | Definition of Females of (Non-) Childbearing Potential and Acceptable Contraceptive Methods | 4.5.2 Definition of Females of (Non-) Childbearing Potential and Acceptable Contraceptive Methods For purposes of this study, females will be considered of childbearing potential unless they are naturally postmenopausal or permanently sterilized (ie, hysterectomy). Natural menopause is defined as the permanent cessatio... | [] |
NCT02087085 | 4.5.3 | Prohibited Medications/Treatments | 4.5.3 Prohibited Medications/Treatments The decision to administer a prohibited medication/treatment is done with the safety of the study participant as the primary consideration. When possible, Allergan should be notified before the prohibited medication/treatment is administered. Use of the following medications is p... | [] |
NCT02087085 | 4.5.4 | Escape Medications | 4.5.4 Escape Medications There are no escape medications for this study. | [] |
NCT02087085 | 4.5.5 | Special Diet or Activities | 4.5.5 Special Diet or Activities Patients are not required to fast prior to blood and urine collections for laboratory tests. | [] |
NCT02087085 | 5 | Study Treatments | 5 Study Treatments | [] |
NCT02087085 | 5.1 | Study Treatments and Formulations | 5.1 Study Treatments and Formulations Brimonidine DDS Applicator System contains implant dosage of 400 µg in a PLA/PLGA biodegradable polymer matrix. | [] |
NCT02087085 | 5.2 | Control Treatment | 5.2 Control Treatment The Sham treatment will consist of a needleless DDS Applicator without study medication and is provided as a sterile finished product. | [] |
NCT02087085 | 5.3 | Methods for Masking | 5.3 Methods for Masking The following individuals at the site will be masked to the study treatment for the duration of the study: - Patients - Assessing investigator(s) who performs ocular assessments (excluding post-injection assessment and DDS assessment) - Study technicians, ie, individuals administering the follow... | [] |
NCT02087085 | 5.4 | Treatment Allocation Ratio and Stratification | 5.4 Treatment Allocation Ratio and Stratification Patients will be randomized to treatment groups (Brimo DDS or Sham) in a 1:1 allocation ratio. Randomization will be stratified by region (North America, Europe, and Australia) and by atrophic lesion area (≤ 8 mm2 versus > 8 mm2 ) in the study eye as assessed by FAF exa... | [] |
NCT02087085 | 5.5 | Method for Assignment to Treatment Groups/Randomization | 5.5 Method for Assignment to Treatment Groups/Randomization Prior to initiation of study treatment, each patient who provides informed consent will be assigned a patient study number that will serve as the identification number on all study documents. An automated interactive voice response system/interactive web respo... | [] |
NCT02087085 | 5.6 | Treatment Regimen and Dosing | 5.6 Treatment Regimen and Dosing Patients who are eligible for the study and have been randomized to receive active treatment, 400 µg Brimo DDS, will receive treatment during the Baseline visit of the study. Patients who are eligible for the study and have been randomized to the Sham treatment will receive the Sham tre... | [] |
NCT02087085 | 5.7 | Storage of Study Medications/Treatments | 5.7 Storage of Study Medications/Treatments The study medication must be stored in a secure area and administered at no cost to the patient and only to patients entered into the clinical study. Administration must be in accordance with the conditions specified in this protocol. The Brimo DDS Applicator System must be s... | [] |
NCT02087085 | 5.8 | Preparation of Study Medications/Treatments | 5.8 Preparation of Study Medications/Treatments Prior to study treatment, the study eye of each patient will be anesthetized with topical anesthetic and prepared according to the standard protocol detailed in the Procedure Manual. The preparation of the patient for treatment (injection) and Sham procedures will be iden... | [] |
NCT02087085 | 5.9 | Treatment Administration | 5.9 Treatment Administration Brimo DDS 400 µg will be administered by intravitreal injection in the study eye. The implant will be injected into the vitreous of the study eye through the pars plana. Refer to the Procedure Manual for the detailed instructions. The Sham treatment is administered using a needleless DDS Ap... | [] |
NCT02087085 | 6 | Response Measures and Summary of Data Collection Methods | 6 Response Measures and Summary of Data Collection Methods | [] |
NCT02087085 | 6.1 | Efficacy Measures | 6.1 Efficacy Measures | [] |
NCT02087085 | 6.1.1 | Primary Efficacy Measure | 6.1.1 Primary Efficacy Measure • Atrophic lesion area in the study eye as assessed with FAF and quantified by the CRC | [] |
NCT02087085 | 6.1.2 | Secondary Efficacy Measures | 6.1.2 Secondary Efficacy Measures - Low luminance BCVA of the study eye as assessed using a 2.0 log unit neutral density filter and the ETDRS visual acuity protocol - Standard BCVA of the study eye assessed using the ETDRS visual acuity protocol | [] |
NCT02087085 | 6.1.3 | Other Outcome Measures | 6.1.3 Other Outcome Measures In addition to the primary and secondary efficacy measurements, the following outcomes will be measured in the study eye: • Retinal sensitivity threshold as assessed with scotopic/mesopic microperimetry  | [] |
NCT02087085 | 6.4 | Examination Procedures, Tests, Equipment, and Techniques | 6.4 Examination Procedures, Tests, Equipment, and Techniques Additional details about the procedures may be found in the Procedure Manual. | [] |
NCT02087085 | 6.4.1 | Certification of Technicians and Examiners | 6.4.1 Certification of Technicians and Examiners To enhance standardization and quality, technicians performing dilated fundus photography, fluorescein angiography, FAF (standard and quantitative), near-IR, SD-OCT, and scotopic/mesopic microperimetry will be certified. Certification by the CRC of the equipment and exam... | [] |
NCT02087085 | 6.4.2 | Standard and Low Luminance Best Corrected Visual Acuity | 6.4.2 Standard and Low Luminance Best Corrected Visual Acuity Standard BCVA will be quantified using the ETDRS visual acuity protocol. BCVA testing should precede any examination requiring contact with the eye. BCVA should be performed following manifest refraction. Low luminance BCVA will be measured using 2.0 log uni... | [] |
NCT02087085 | 6.4.3 | Spectral-domain Optical Coherence Tomography | 6.4.3 Spectral-domain Optical Coherence Tomography  CRC; images from the Screening Visit 1 will be used to define foveal involvement and patient eligibility as confirmed by the CRC. | [] |
NCT02087085 | 6.4.4 | Microperimetry | 6.4.4 Microperimetry Scotopic/mesopic microperimetry will be performed at selected sites. Patients at these sites can enroll into the study if they decline to participate in the scotopic/mesopic microperimetry assessments, or if they do not meet inclusion criterion #9 (Section [4.3](#page-22-0)). Scotopic/mesopic micro... | [] |
NCT02087085 | 6.4.5 | Confocal Scanning Laser Ophthalmoscopy: Near-infrared Reflectance (3-field) | 6.4.5 Confocal Scanning Laser Ophthalmoscopy: Near-infrared Reflectance (3-field) A standardized procedure for obtaining near-IR images using the is included in the Procedure Manual. Three-field images collected at the specified visits will be sent to the CRC. | [] |
NCT02087085 | 6.4.6 | Confocal Scanning Laser Ophthalmoscopy: Quantitative (Central Field) and Standard (3-field) Fundus Autofluorescence | 6.4.6 Confocal Scanning Laser Ophthalmoscopy: Quantitative (Central Field) and Standard (3-field) Fundus Autofluorescence A standardized procedure for obtaining FAF images using the confocal scanning laser ophthalmoscopy (cSLO) capability of the is included in the Procedure Manual. In addition to the standard FAF imagi... | [] |
NCT02087085 | 6.4.7 | Fluorescein Angiography | 6.4.7 Fluorescein Angiography Fluorescein angiographic imaging should be performed with the ; if this system is not available investigators may collect these images with a standard fundus camera based system (the minimum requirements for settings are described in the Procedure Manual). Images collected at the Screening... | [] |
NCT02087085 | 6.4.8 | Indocyanine Green Angiography (Optional) | 6.4.8 Indocyanine Green Angiography (Optional) Indocyanine green (ICG) angiography may be performed during Screening Visit 1 if it is considered necessary to exclude patients with late-onset Stargardt disease. A standardized procedure for the collection of ICG angiograms from both eyes is included in the Procedure Manu... | [] |
NCT02087085 | 6.4.9 | Dilated Fundus Photography | 6.4.9 Dilated Fundus Photography Dilated fundus photographic images (fundus reflex, 3-field color imaging, and central field red-free photographs) will be collected from both eyes at the Screening Visit 1 and the Exit visit. These fundus images will be kept at the site and copies will be sent to the CRC. The images col... | [] |
NCT02087085 | 6.5 | Other Study Supplies | 6.5 Other Study Supplies Allergan will make provisions (directly or indirectly) to supply the study sites with pregnancy test kits; ETDRS instrumentation (if needed); medications or supplies (eg, antiinfective ophthalmic solution, local anesthetic eye drop, dilating eye drop, povidone iodine, syringe, needles, cotton t... | [] |
NCT02087085 | 6.6 | Summary of Methods of Data Collection | 6.6 Summary of Methods of Data Collection Clinical data for this study will be collected in eCRFs using the Phase Forward Inform System. Data entered into the eCRF will correspond to and be supported by source documentation maintained at the site. Data will be transferred to Allergan from the CRC and genotyping laborat... | [] |
NCT02087085 | 7 | Statistical Procedures | 7 Statistical Procedures The primary analysis for efficacy will be based on data collected through Month 24. An interim analysis may be performed after 50% of patients complete the Month 18 visit. Up to 3 database locks are planned for the study: an interim lock at Month 18 (50% of patients), the primary lock at Month ... | [] |
NCT02087085 | 7.1 | Analysis Populations | 7.1 Analysis Populations The following 2 populations will be used for statistical analyses: modified intent-to-treat (mITT) and safety. The mITT population will include all randomized and treated patients with Baseline and at least one post-baseline measurement for the atrophic lesion area. The mITT population will be ... | [] |
NCT02087085 | 7.2 | Collection and Derivation of Primary and Secondary Efficacy Assessments | 7.2 Collection and Derivation of Primary and Secondary Efficacy Assessments The primary efficacy measure in this study is the atrophic lesion area measured by FAF examination. The primary timepoint for the efficacy analysis is Month 24. | [] |
NCT02087085 | 7.2.1 | Primary Efficacy Variable | 7.2.1 Primary Efficacy Variable The primary efficacy variable is the change from Baseline in the atrophic lesion area in the study eye, assessed with FAF and quantified by the CRC. | [] |
NCT02087085 | 7.2.2 | Secondary Efficacy Variables | 7.2.2 Secondary Efficacy Variables The secondary efficacy variables are (1) change from Baseline in low luminance BCVA in the study eye as assessed using a 2.0 log unit neutral density filter and the ETDRS visual acuity protocol (2) change from Baseline in standard BCVA in the study eye as assessed with the ETDRS visua... | [] |
NCT02087085 | 7.3 | Hypothesis and Methods of Analysis | 7.3 Hypothesis and Methods of Analysis | [] |
NCT02087085 | 7.3.1 | Primary Efficacy Analyses | 7.3.1 Primary Efficacy Analyses The primary efficacy variable is the change from Baseline in atrophic lesion area in the study eye. The primary analysis will use the mITT population and will be based on a mixed model for repeated measures (MMRM) that includes treatment, study region (North America, Europe, and Australi... | [] |
NCT02087085 | 7.3.2 | Secondary Efficacy Analyses | 7.3.2 Secondary Efficacy Analyses Analysis of data collected for both standard and low luminance BCVA will include change from baseline in BCVA scores as the number of letters read correctly and categorical change in BCVA. . Analyses will be performed using the mITT population. MMRM that includes treatment, study regio... | [] |
NCT02087085 | 7.3.4 | Safety Analyses | 7.3.4 Safety Analyses Statistical analysis for safety will be based on the safety population. The Medical Dictionary for Regulatory Activities (MedDRA) nomenclature will be used to code adverse events and biomicroscopy and ophthalmoscopy data. The number and percent of patients reporting adverse events will be tabulate... | [] |
NCT02087085 | 7.4 | Subgroup Analyses | 7.4 Subgroup Analyses Analyses of subgroups defined by important baseline disease characteristics (such as lesion size), will be performed, if applicable. | [] |
NCT02087085 | 7.5 | Sample Size Calculation | 7.5 Sample Size Calculation A standard method for measuring disease progression in patients with GA secondary to AMD is to quantify the expansion rate of the areas of atrophy. Over a 12-month period this expansion rate typically ranges between 1 and 2 mm2 ([Sunness et al, 2007; Holz et al, 2007;](#page-65-0) [Holz et a... | [] |
NCT02087085 | 7.6 | Interim Analyses | 7.6 Interim Analyses An interim analysis may be performed after 50% of patients have completed the Month 18 visit or have exited early from the study. To maintain an overall Type I error rate at 0.05 level, the significance level will be 0.001 for the interim analysis at Month 18 and 0.05 (Haybittle–Peto method) for th... | [] |
NCT02087085 | 8.1 | Patient Entry Procedures | 8.1 Patient Entry Procedures | [] |
NCT02087085 | 8.1.1 | Overview of Entry Procedures | 8.1.1 Overview of Entry Procedures Prospective patients as defined by the criteria in Sections [4.3](#page-22-0) and [4.4](#page-23-0) (inclusion/exclusion criteria) will be considered for entry into this study. | [] |
NCT02087085 | 8.1.2 | Informed Consent and Patient Privacy | 8.1.2 Informed Consent and Patient Privacy The study will be discussed with the patient and a patient wishing to participate must give informed consent prior to any study-related procedures or change in treatment. The patient must also give authorization (US only), data protection consent (Europe only), and other writt... | [] |
NCT02087085 | 8.2 | Procedures for Final Study Entry | 8.2 Procedures for Final Study Entry Patient eligibility based on lesion characteristics, as well as the reproducibility of the retinal sensitivity measurements, must be confirmed by the CRC prior to patient randomization. Patients at sites participating in scotopic/mesopic microperimetry can enroll into the study if t... | [] |
NCT02087085 | 8.4 | Instructions for the Patients | 8.4 Instructions for the Patients If a site dispenses pre- and/or post-injection anti-infectives, at the time the anti-infectives are dispensed, the patient should be instructed when and how to use them. | [] |
NCT02087085 | 8.5 | Unscheduled Visits | 8.5 Unscheduled Visits Additional examinations may be performed as necessary to ensure the safety and wellbeing of patients during the study. The eCRF should be completed for each unscheduled visit. | [] |
NCT02087085 | 8.6 | Compliance With Protocol | 8.6 Compliance With Protocol Allergan must be informed of any patients who are inadvertently enrolled despite significant deviation from protocol-specified criteria. A decision regarding the patient's continued participation will be made on a case-by-case basis. | [] |
NCT02087085 | 8.7 | Early Discontinuation of Patients | 8.7 Early Discontinuation of Patients Patients may voluntarily withdraw from the study at any time. The investigator may stop the patient's participation at any time. Notification of patient discontinuation from the study and the reason for discontinuation will be made to Allergan and will be clearly documented on the ... | [] |
NCT02087085 | 8.7.1 | Treatment Failures | 8.7.1 Treatment Failures Allergan considers the benefit-risk of study participation to be positive, and does not recommend study discontinuation due to treatment failure. Currently, there are no approved treatments for GA, and consequently there are no standard-of-care treatment options available for patients who fail ... | [] |
NCT02087085 | 8.8 | Study Termination | 8.8 Study Termination The study may be stopped at his/her study site at any time by the site investigator. Allergan may stop the study (and/or the study site) for any reason with appropriate notification. | [] |
NCT02087085 | 9 | Adverse Events | 9 Adverse Events Adverse events occurring during the study will be recorded on an adverse event eCRF. If adverse events occur, the first concern will be the safety of the study participants. | [] |
NCT02087085 | 9.1 | Definitions | 9.1 Definitions | [] |
NCT02087085 | 9.1.1 | Adverse Event | 9.1.1 Adverse Event An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an a... | [] |
NCT02087085 | 9.1.2 | Serious Adverse Event | 9.1.2 Serious Adverse Event A serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital... | [] |
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