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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT01345006
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female over 18 years of age.
* Clinical diagnosis of advanced SMD.
* If known, the patient's genotype will be recorded in the medical history, if unknown, patient will allow for the submission of a sample for genotyping.Clinical findings consistent with SMD.
* The visual acuity of the eye to receive the transplant will be no better than 20/400. The visual acuity of the eye in the better vision cohort to receive the transplant will be no better than 20/100.
* The visual acuity of the eye that is not to receive the transplant will be no better than 20/400 for the worse vision patients and no worse than 20/100 for the better vision patients.
* Peripheral visual field constriction documented on standard kinetic visual field testing.
* Electrophysiological findings consistent with SMD.
* Medically suitable to undergo vitrectomy and subretinal injection.
* Medically suitable for general anesthesia or waking sedation, if needed.
* Medically suitable for transplantation of an embryonic stem cell line:
* Normal serum chemistry (sequential multi-channel analyzer 20 \[SMA- 20\]) and hematology (complete blood count \[CBC\], prothrombin time \[PT\], and activated partial thromboplastin time \[aPTT\]) screening tests.
* Negative urine screen for drugs of abuse.
* Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serologies.
* No history of malignancy,with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
* Negative cancer screening within previous 6 months:
* complete history \& physical examination;
* dermatological screening exam for malignant lesions;
* negative fecal occult blood test \& if over age 50 years, negative colonoscopy within previous 7 years;
* negative chest roentgenogram (CXR);
* normal CBC \& manual differential;
* negative urinalysis (U/A);
* normal thyroid exam;
* if male, normal testicular examination; if over age 40, digital rectal examination (DRE) and prostate specific antigen (PSA);
* if female, normal pelvic examination with Papanicolaou smear; and
* if female, normal clinical breast exam and if 40 years of age or older, negative mammogram.
* If female and of childbearing potential, willing to use two effective forms of birth control during the study.
* If male, willing to use barrier and spermicide contraception during the study.
* Willing to defer all future blood, blood component or tissue donation. -Able to understand and willing to sign the informed consent.
Exclusion Criteria:
* History of malignancy,with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
* History of myocardial infarction in previous 12 months.
* History of diabetes mellitus.
* Any immunodeficiency.
* Any current immunosuppressive therapy other than intermittent or low dose corticosteroids.
* Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
* Current participation in any other clinical trial.
* Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
* Any other sight-threatening ocular disease.
* Any chronic ocular medications.
* Any history of retinal vascular disease (compromised blood-retinal barrier.
* Glaucoma.
* Uveitis or other intraocular inflammatory disease.
* Significant lens opacities or other media opacity.
* Ocular lens removal within previous 3 months.
* If female, pregnancy or lactation.
* Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01345006
Study Brief:
Protocol Section:
NCT01345006