People s Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial
Completed
Conditions studied: Retinoschisis, X-Linked
In brief
Background: -X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more about how people with XLRS choose to take part in research studies. They hope to find ways to help other people make decisions about joining early phase trials Objective: -To learn more about how people think and feel about taking part in early phase research. Eligibility: -Adults age 18 or older with diagnosed XLRS. They must be eligible to be screened for a Phase I/II ocular gene transfer clinical trial. Design: * Participants will be screened for the XLRS gene transfer study. They will be interviewed: * Eligible participants who join the study - before the gene transfer procedure, then 3 months and 12 months after it. * Eligible participants who do not join the study - after their screening visit and 3 months and 12 months later. \<TAB\>- Participants who are screened but ineligible - after their screening visit. \<TAB\>- Participants who choose not to be screened - at the time they make the decision and 1 year later. * Interviews will ask for the participants thoughts about the clinical trial and why they chose to take part or not. The interviews will be recorded. * On the day of interview 1, participants will fill out a survey about their mood and personality. * On the days of interviews 2 and 3, participants will fill out a survey about their mood. * Interviews may be done in person or by phone. Surveys can be done online or through the mail. Or they can be done in person at the NIH Clinical Center.
Key facts
- Study ID
- NCT02317354
- Run by
- National Eye Institute (NEI)
- People needed
- 13
- Starts
- 2014-12-13
- Expected to finish
- 2017-11-20
- Last updated by the study team
- 2019-12-09
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may not qualify if…
- Participants may not be able to take part in this study if they:
- Have eye findings or other medical conditions that would preclude consideration for participation in a Phase I/II ocular gene transfer clinical trial.
- Are receiving experimental treatment for XLRS in another research study.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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