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Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients — ZM-02  

Retinitis Pigmentosa Clinical Trial

Official title:
Prospective, Dose-Escalating, Investigator Initiated Trial to Evaluate the Safety and Efficacy of ZM-02 in Retinitis Pigmentosa

Clinical Trial Summary

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.

Clinical Trial Description

Retinitis pigmentosa (RP) is the most common inherited retinal disease. Individuals affected by RP often experience progressive visual impairment, potentially leading to legal blindness. There is currently no established effective clinical treatment available. We developed an innovative adeno-associated virus (AAV)-based gene therapy for individuals with RP, regardless of their causative mutations. Eight to twelve subjects with RP will be recruited and six to nine of them will receive a single unilateral intravitreal injection of ZM-02 at ascending doses, while two to three receive sham injections as the control group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06292650
Study type Interventional
Source Zhongmou Therapeutics
Contact Pei Cao
Phone +86 18707134160
Email zmt@simbaeye.com
Status Not yet recruiting
Phase Early Phase 1
Start date February 25, 2024
Completion date December 25, 2028
View Details
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