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:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02280135
Eligibility Criteria:
Inclusion Criteria:
* Retinitis Pigmentosa bilateral diagnosis.
* Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below 30° central in both eyes.
* Signed informed consent
* Warranty sufficient adherence to protocol. It must fulfill all inclusion criteria.
Exclusion Criteria:
* Concurrence of any systemic or ocular disease that precludes or affects tracking study variables. Specifically retinal involvement with diabetes mellitus, glaucoma, macular degeneration or age.
* Eye surgery in the previous 6 months.
* Patients who are pregnant.
* Patients with active lactation.
* Physically fertile patients, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation excludes sexual intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS tHEY are using a reliable contraceptive method. This birth control method can be:
* Complete abstinence from sexual intercourse
* Surgical sterilization (tubal ligation)
* Surgical sterilization partner (vasectomy)
* Implanted or injectable hormonal contraceptives and oral.
* Patients with cardiac disease, renal, hepatic, systemic, immune that might influence the survival of patients during the test.
* Positive serology for hepatitis B, hepatitis C or HIV.
* Clinical criteria or anesthetics that contraindicate the sedation or the extraction of BM (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin in the puncture site, etc.)
* Participation in other clinical trials.
* Inability to sign informed consent or understanding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02280135
Study Brief:
Protocol Section:
NCT02280135