A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP

Exclusion Criteria

• •1. 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.
• •2. For participants with herpes simplex virus (HSV):
• •1. Have history of oral or genital herpes and unable and/or unwilling to utilize prophylactic antiviral medication.
• •2. Have a history of ocular herpes.
• •3. Have active oral or genital herpes or are currently receiving treatment for HSV infection.
• •3. Have known sensitivity or allergy to systemic corticosteroids or other immunosuppressive medications.
• •4. Have used anti-coagulant agents that may alter coagulation
• •5. Have used systemic corticosteroids or other immunosuppressive medications within 3 months prior to screening and/or intend to use during screening. Corticosteroids used on an as-needed basis administered by insufflation, inhalation or local administration to the skin
• •6. If sexually active or planning to become sexually active, are unwilling to use barrier contraception for 3 months following treatment administration.
• •7. Are currently participating or recently participated in any other research
• •8. Have previously received any AAV gene therapy product, stem cell therapy, cell-based therapy, or similar biologics.
• •9. Have significant media opacity impacting evaluation of the retina or vitreous. administration.
• •10. Had intraocular surgery within 90 days of study treatment administration.
• •11. Have any active ocular/intraocular infection or inflammation
• •12. Have a history of corticosteroid-induced raised IOP of \>25 mmHg following corticosteroid exposure, despite topical IOP-lowering pharmacologic therapy.
• •13. Have any artificial retinal implant or prosthesis.
• •14. Have absence of clear ocular media and/or inadequate pupil dilation to facilitate good quality SD-OCT images.
• •15. Have any history of rhegmatogenous retinal detachment.
• •16. Have myopia (spherical equivalent) exceeding -10 diopters (or axial length of \>30 mm if the Principal Investigator \[PI\] deems it appropriate to measure) or presence of pathologic myopia in the study eye.
• •17. Have passed the Low Contrast Ora-VNC mobility course at ≤0.35 lux light level in either eye or binocularly at any screening visit.