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

Plain-language summary

This study investigates the expectations of people considering enrollment in an ocular (eye) gene transfer trial for X-linked retinoschisis (XLRS, an inherited eye disease caused by mutations in the RS1 gene). It included people over 18 with a molecular diagnosis of XLRS. It is an observational (non-phase) study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

National Eye Institute (NEI)

Start date

12/13/2014

Estimated completion

11/20/2017

Countries

United States

Related genes

Locations

• Bethesda, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

* INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.