Clinical Trial: People s Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational



Official Title: Patient Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial

Brief Summary:

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 pers