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Clinical Trial Details
Research Study Summary
Patients are needed to participate in a clinical research study of UshStat to evaluate Usher Syndrome or Retinitis Pigmentosa
Research Study Title
A Phase I/IIa Dose Escalation Safety Study of Subretinally Injected UshStat, Administered to Patients With Retinitis Pigmentosa Associated With Usher Syndrome Type 1B
The purpose of this first in man study is to examine the safety of an experimental gene
transfer agent, UshStat designed to treat retinitis pigmentosa associated with Usher
Syndrome Type 1B.
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Both Male and Female
Both Male and Female ages 18 Years and up
Clinical and molecular diagnosis of Retinitis Pigmentosa associated with Usher
Syndrome type 1B. With at least one pathogenic mutation in the MYO7A gene on each
Suitable verbal, auditory,written and/or tactile sign language communication as to
allow informed consent to be obtained.
Women of childbearing potential must agree to use two forms of contraception.
Males must agree to use two forms of contraception if their study partner is of
child-bearing potential for three months after treatment.
Affiliated with the French social security healthcare system (french patients only)
Presence of significant ocular abnormalities that would preclude surgery, effective
study follow up or interfere with study endpoints.
Concomitant systemic diseases that can alter visual function.
Contraindication to pupil dilation, anesthesia or eye surgery.
Periocular steroids in the last four months prior to screen.
Known allergies to the components of the delivery vehicle or diagnostic agents such
as dilation drops.
Life-threatening illness or a history of malignancy within 5 years
Laboratory test abnormalities that would make the patient unsuitable for
participation in the study
Intercurrent illnesses or infections 28 days prior to treatment
Concurrent anti-retroviral or immunosuppressant therapy
Men or women who do not agree to use contraception as specified in the inclusion
Pregnant or breastfeeding women
Enrollment in any other clinical study during the 48 week study period
Treatment with anticoagulants
Past history of HIV or hepatitis A, B or C
Inability to comply with the demands of the study
Any ocular surgery in the study eye within 6 months
Site Locations (2)
||Investigational Site Number 840001
||Investigational Site Number 250001
NCT ID: NCT01505062
Date Last Changed: January 21, 2015
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