Prospective, Dose-Escalating, Investigator Initiated Trial to Evaluate the Safety and Efficacy of ZM-02 in Retinitis Pigmentosa
This is zM-02's safety, tOlerability, and efficacy in retinitis pigmentOsa first-in-humaN study (MOON). This trial is meant to evaluate the safety and efficacy of ZM-02 in Retinitis pigmentosa (RP) patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.
⁃ Patients who meet all of the following criteria can be selected as subjects:
• Clinically diagnosed with retinal pigment degeneration
• The vision of the eye being tested is no better than the index value, while the vision of the opposite eye is not better than that of the tested eye
• The subject has had visual experience above the index value
• In the OCT examination of the tested eye, the disappearance of the ellipsoid zone is observed, but the inner nuclear layer and the nerve fiber layer of the retina are still present
• The refractive power of the tested eye is between -6.00 D and +6.00 D
• Not infected with the Human Immunodeficiency Virus (HIV) and other acute and chronic infectious diseases
• Voluntarily sign an Informed Consent Form (ICF), and the age is not less than 18 years and not more than 65 years
• Able to fully understand and agree to cooperate with the implementation of the research protocol