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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT07088705
Eligibility Criteria:
Inclusion criteria:
* Clinically diagnosed RP, including (i) characteristic fundus appearance with waxy pallor of the optic disc; (ii) reduced retinal vessel diameter and intraretinal pigment deposits in the central periphery of the fundus; (iii) history of progressive night vision and/or color vision impairment, peripheral vision loss, photophobia, reduced visual acuity, and prolonged dark adaptation; (iv) peripheral narrowing to "tunnel vision" on visual field testing; (v) significant amplitude reduction with prolonged waveform latency or unrecordable readings on flash electroretinography (ERG) and confirmed by NGS panel sequencing covering all known genes responsible for retinal dystrophic diseases or Whole Exome Sequencing (WES);
* Age 18-70 years; - BCDVA no lower than 0.08 (according to the Snellen chart);
* Ability to provide informed consent.
Exclusion criteria:
* Age \<18 years - \>70 years;
* Systemic diseases (acute inflammatory or autoimmune process, recent trauma, renal or hepatic failure, cardiovascular or neurological disease, stroke, cancer, diabetes, autoimmune diseases);
* Other eye diseases (e.g., glaucoma, age-related macular degeneration, vitreous degeneration); - Post-ocular surgery except uncomplicated cataract surgery;
* Cataract surgery or posterior capsulotomy less than 3 months prior to study enrollment;
* Systemic or topical use of immunomodulatory medications;
* Use of any other RP treatment, including dietary supplements, during the study or in the 3 months prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07088705
Study Brief:
Protocol Section:
NCT07088705