Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients
ConditionRetinitis Pigmentosa
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhongmou Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
Clinically diagnosed with retinal pigment degeneration
The visual acuity of study eye is no better than the finger counting, while the visual acuity of the study eye is not better than that of the contralateral eye
The subject has had visual experience above the finger counting
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
Disqualifiers
Pregnant women, breastfeeding women, or male and female subjects who do not agree to contraception during the 12 months before and after medication
Subjects with narrow anterior chamber angles or any other medical conditions that contraindicate pupil dilation
Subjects allergic to corticosteroids, who are unable to tolerate the corticosteroid treatment described in the protocol, or have active 4. concurrent infections that contraindicate treatment
Subjects with systemic diseases, or other medical or mental illnesses, or other safety concerns for the study
Trial design
Treatments tested in this trial
- ZM-02-L
- ZM-02-H
- ZM-02-S
Treatment groups
12 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov