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

NCT02317354 | Completed

• 2 other identifiers: 15004115-EI-0041
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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 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

Keywords

X-Linked; Retinoschisis

Outcome Measures

Primary Outcomes (1)

• Desc. expectation pt enroll ct

  Study Completion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants may be eligible to take part in this study if they:
• Are 18 years of age or older.
• Have a molecular diagnosis of XLRS and are eligible to be screened for a Phase I/II ocular gene transfer clinical trial.
• Are able to understand and comply with the procedures of this study.

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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Jansen LA. Two concepts of therapeutic optimism. J Med Ethics. 2011 Sep;37(9):563-6. doi: 10.1136/jme.2010.038943. Epub 2011 May 7.

  PMID: 21551464 BACKGROUND

• Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982;5(3-4):319-29. doi: 10.1016/0160-2527(82)90026-7. No abstract available.

  PMID: 6135666 BACKGROUND

MeSH Terms

Conditions

Retinoschisis

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Amy E Turriff

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2014
• First Posted: December 16, 2014
• Study Start: December 13, 2014
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: December 9, 2019

Record last verified: 2017-11-20

Locations

US (1)