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

NCT02317354 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2019-12-09

No results posted yet for this study

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 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.

Conditions

  • Retinoschisis
  • X-Linked

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Amy E Turriff · National Eye Institute (NEI)

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-13
Primary Completion
2017-11-20
Completion
2017-11-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02317354 on ClinicalTrials.gov