Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:22 AM
Ignite Modification Date:
2025-12-25 @ 4:22 AM
NCT ID:
NCT06275620
Eligibility Criteria:
Inclusion Criteria:
* Be ≥12 years of age
* Have one eye previously treated with an AAV vector-based gene therapy designed to provide full-length functioning RPGR protein.
* Have a BCVA no better than 78 letters and no worse than 34 letters
* Be able to perform all tests of visual and retinal function and structure in both eyes based on the participant's reliability and fixation, per the Investigator's discretion.
* Have detectable baseline mean macular sensitivity measured by MAIA microperimetry, as determined by the Investigator and confirmed by the Central Reading Center (CRC).
* Have detectable EZ line in the study eye as assessed by SD-OCT and confirmed by the CRC.
Exclusion Criteria:
* Have other known disease-causing mutations documented in the participant's medical history or identified through a retinal dystrophy gene panel that, in the opinion of the Investigator, would interfere with the potential therapeutic effect of the study agent or the quality of the assessments.
* Have pre-existing eye conditions that would preclude the planned surgery, interfere with the interpretation of study endpoints, or increase the risk of surgical complications
* Had intraocular surgery within 90 days of study treatment administration.
* Have any active ocular/intraocular infection or inflammation
* Have a history of steroid-induced raised IOP of \>25 mmHg following corticosteroid exposure, despite topical IOP-lowering pharmacologic therapy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Study:
NCT06275620
Study Brief:
Protocol Section:
NCT06275620