Description of the Study. If you agree to be in this study, you will be asked to sign this consent form. You will be asked to complete a questionnaire asking about your age, gender, ethnicity, and if you are currently seeing a healthcare professional for active sleep or mental health problems. Your eligibility to participate in this study will be based on your age. If you qualify for the study, you will be asked to take part in a number of optional study procedures, as outlined below: Baseline Assessment You will be asked to complete a series of questionnaires about your sleep and your satisfaction with your sleep, mood, energy, and quality of life (30 minutes). Upon completing the questionnaires, you will be given a unique numeric code, which will be required to activate the DOZe app at sign-in (in addition to your email address). You will also be given a link to access DOZe through your web-browser. You will be directed to access the DOZe app online (using a mobile device or a computer), where you will create a profile by entering your age, email address, the unique numeric code, and by creating a password. Pre-Intervention Procedures You will receive an email each morning to complete a sleep diary on the DOZe app to answer questions about the previous night’s sleep (e.g., “What time did you get into bed? What time did you try to fall asleep?”) (about 5 minutes). You must complete two weeks of the sleep diary before receiving recommendations to improve your sleep. Intervention Procedures Based on the results of your sleep diary, the app will recommend specific areas where you can improve your sleep, and provide you with strategies to do so. You can set goals in the app and choose whether you want to use the recommended strategies to meet your goals. After setting goals, you will continue to complete a sleep log each morning for two more weeks (about 5 minutes). You will have the opportunity to monitor your progress on reaching your goals in the app. You will also have access to other in-app features, such as additional tips to learn about other strategies to improve your sleep.
Description of the Study. What kind of study is this?
Description of the Study. The Study shall be conducted according to the terms of this Agreement and the Protocol which is incorporated by reference hereto as Exhibit A: Study Protocol, which fully details the clinical research activities and responsibilities to be undertaken. In the event there is a conflict between the terms of the Agreement and the Protocol with respect to any of the provisions contained within the Agreement, the Agreement shall control. In the event of any conflict between the Protocol and the Agreement with respect to the procedure(s) or methodology for performance of the Study, the Protocol shall control.
Description of the Study. Rutgers/UMDNJ and the Principal Investigators (as defined below) agree to conduct a research program for the further development of the Inventions (the "Study") during the term of this agreement. The Study shall be conducted according to the research protocol which is attached hereto as Exhibit B (the "Research Protocol") and fully details the research activities and responsibilities to be undertaken for the first year of the Study. The Research Protocol for each year of the Study commencing after the first year shall be added to Exhibit B, following the completion of good-faith negotiations between Sponsor and Rutgers/UMDNJ, which discussions shall begin ninety (90) days prior to the end of the Study for the immediately preceding year. Sponsor shall fund this Study for a period of three (3) years pursuant to paragraph 4 and subject to the termination provisions of paragraph 7.
Description of the Study. This is a prospective, open-labelled study in patients with pigment epithelial detachment (PED) secondary to neovascular macular degeneration. All subjects will receive 6.0mg of intravitreal brolucizumab every 4 weeks between baseline and week 8 (3 loading doses), and subsequently receive 6.0mg of intravitreal brolucizumab every 8 or 12 weeks for the remainder of the study period (weeks 52). Fifty five subjects who meet the inclusion/exclusion criteria will be recruited from Sydney Retina Clinic and followed up for 52 weeks. All assessments and treatments will be performed at Sydney Retina Clinic. All eligible subjects will initially receive 3 monthly loading doses of 6.0mg of intravitreal brolucizumab injection. Following these loading doses, a disease activity assessment will be performed at week 16. Disease Activity Criteria at Week 16: Decrease in BCVA of ≥ 5 letters compared with Baseline Decrease in BCVA of ≥ 3 letters and CSFT increase ≥ 75μm compared with Week 12 Decrease in BCVA of ≥ 5 letters due to neovascular AMD disease activity compared with Week 12 New or worse intraretinal cysts (IRC) /intraretinal fluid (IRF) compared with Week 12 If a subject meet any of the above disease criteria at week 16, the subject will be assigned to receive injections every 8 weeks (q8w) thereafter, up to study exit (Week 16, 24, 32, 40 and 48). If a subject does not meet any of the above disease activity criteria, the subject will be injected every 12 weeks (q12w) up to study exit (week 20, 32 and 44).
Description of the Study
