Phase
Condition
Eye Disorders/infections
Retinitis Pigmentosa
Posterior Uveitis
Treatment
RTx-015
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults ≥18 years of age
Informed consent obtained from the patient
Clinical diagnosis of Retinitis Pigmentosa independent of causative mutation ORClinical diagnosis of Choroideremia with known causative mutation
Study eye and fellow eye Best Corrected Visual Acuity meeting study criteria
Presence of retinal ganglion cells and/or retinal nerve fiber layer on SpectralDomain Optical Coherence Tomography testing at Screening confirmed by central imagereading center
Adequate organ function and general good health
Exclusion
Exclusion Criteria:
Participation in a clinical study (ocular or non-ocular) with an investigationaldrug, agent, or therapy in the past six months
Concurrent participation in another interventional clinical ocular study
Prior receipt of any gene therapy (ocular or other), retinal implant, or ocular celltherapy
Pre-existing eye conditions in either eye that would preclude the planned treatmentor, in the opinion of the Investigator, are significant enough to interfere with theinterpretation of study endpoints or procedural complications
Known steroid responders if their intraocular pressure was not able to be managedeffectively with topical pressure-lowering medications after prior use of steroidmedications
Complicating systemic diseases; complicating systemic diseases include those inwhich the disease itself, or the treatment for the disease, can alter ocular and/orCentral Nervous System (CNS) function (e.g., radiation treatment of the orbit;leukemia with CNS/optic nerve involvement)
Any immunological response dysfunction including, immuno-compromising diseases oruse of immunosuppressive medications, among others
Cataract or other ocular (including refractive) surgery, intraocular and/orperi-ocular injection in either eye within the prior four months (i.e., 120 days)prior to screening
Prior vitrectomy or aphakia in the study eye
Known sensitivity to any component of the study treatment or contraindication tomedications planned for use in the peri-procedural period (e.g., povidone-iodine toprep for intravitreal injection)
Known contraindication to prophylactic steroid regimen
Current pregnancy or breastfeeding
Any other condition that would not allow the patient to complete follow-upexaminations during the study
Study Design
Study Description
Connect with a study center
Retina Vitreous Associates Medical Group
Beverly Hills, California 90211
United StatesActive - Recruiting
UCI Alpha Clinic
Orange, California 92868
United StatesActive - Recruiting
UPMC Vision Institute
Pittsburgh, Pennsylvania 15221
United StatesActive - Recruiting
Retina Consultants of Texas Research Centers
Bellaire, Texas 77401
United StatesActive - Recruiting
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