Duration of the study. The active study phase for each patient is 180 days. Enrolment is expected to begin in Q1 2008; the study is expected to end X0 0000. 10 Data Handling and Record Keeping
Duration of the study. The patients will be clinically followed throughout the course of their hospital admission. The data collected during surgery and postoperative course will be used to evaluate the efficacy of the MvIGS spine navigation system. As designed, a total of 130 patients are to be enrolled in the study, with 65 patients per treatment group. Based on this sample size, rate of patient accrual, and the prescribed follow- up time, the total duration of the study is projected to be approximately 9 months.
Duration of the study. The [***] is [***] to be [***]r. Any [***] will be [***] to [***] at that time.
Duration of the study. The study that is the subject matter of this agreement may begin once the pertinent permits and administrative authorizations have been obtained, from the date it is signed, and will have an estimated duration of <<xxxxxx>> months from the start thereof. If recruitment has not been completed within the appropriate time frames, the contracting parties shall adopt, by mutual agreement, such provisions as they may deem appropriate. The study shall be suspended before its completion, by written notification, if any of the following circumstances should arise: Due to the principal investigator’s noncompliance with the terms of this agreement. If compliance with the protocol is deficient or the data recorded is repeatedly inaccurate or incomplete. By mutual agreement in writing among the contracting parties. If the Sponsor decides to terminate or suspend it for business reasons or for not being able to complete it due to a lack of patients or centers. The Sponsor shall prepare a report explaining the reasons for suspending the study. If the study should be suspended, the sponsor shall notify all the appropriate health authorities and the participating centers’ CRECs of the suspension.
Duration of the study. Following a Screening Visit, at Baseline Visit (Day 0) the study eye will receive injection of RBM-007. The primary study endpoint will be at 28 days after RBM-007 injection, at which time anti-VEGF treatment can be resumed according to the investigating physician. Follow up will continue to the exit visit at 56 days. Diagnosis and Main Criteria for Inclusion: • Provide signed written informed consent on the IRB / EC approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations. • Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and follow-up study procedures. At Screening Visit, subjects must meet all the following inclusion criteria: • Must have had prior treatment in the study eye with any intravitreal anti-VEGF medication (at least 3 anti- VEGF treatments within the prior 2-6 months), throughout which clinical examination and SD-OCT imaging has shown recurrent or persistent exudative activity, as shown by the presence of intraretinal or subretinal fluid, and/or subretinal exudation or hemorrhage. • BCVA of 65 to 10 ETDRS letters (20/50 to ≥20/640) in the study eye. • Presence of significant subretinal fluid and/or cystoid macular edema secondary to exudative age-related macular degeneration as assessed by SD-OCT in the study eye, with a minimum of 300 µm within the central subfield. • Total lesion size of ≤9 disc areas, lesion containing ≤50% hemorrhage in the study eye. • Reasonably clear media and reasonable fixation ability in the study eye to allow for good quality SD-OCT and fundus photography. At Baseline Visit (Day 0), subjects must meet all the following inclusion criteria: • BCVA of 65 to 10 ETDRS letters (20/50 to ≥20/640) in the study eye. • Presence of significant subretinal and/or intraretinal fluid secondary to exudative age-related macular degeneration as assessed by SD-OCT in the study eye, with a minimum of 300 µm within the central subfield. • Total lesion size of ≤9 disc areas, lesion containing ≤50% hemorrhage in the study eye. Study Eye If both eyes of a subject meet the eligibility criteria, then study eye will be determined as the eye with the worse vision. If both eyes have the same vision, the right eye (OD) should be determined as the study eye. Investigational product, dosage and mode of administration: Subjects will receive one of the following three dose levels of the investigational product, RBM-007 injecta...
