Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Retinitis Pigmentosa (RP)

In brief

This is a Phase 1/2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).

Key facts

Study ID

NCT07282457

Run by

Zhongmou Therapeutics

People needed

21

Starts

2026-06-25

Expected to finish

2031-12-25

Last updated by the study team

2026-04-13

Who can join

Age: 6 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants aged 6 to 60 years.
• Clinical diagnosis of advanced retinitis pigmentosa (RP).
• Best corrected visual acuity at or below the protocol-defined threshold in the study eye.
• Presence of sufficient retinal structure in the study eye as determined by screening assessments.
• Ability to understand and sign informed consent (and assent, when applicable).

You may not qualify if…

• Presence of other ocular conditions that could interfere with study assessments.
• History of significant ocular surgery in the study eye within a protocol-defined period.
• Active ocular infection or inflammation.
• Clinically significant systemic disease that could increase study risk or interfere with assessments.
• Positive screening for clinically significant infectious diseases, as defined in the protocol.
• Pregnant or breastfeeding individuals.
• Any condition that, in the investigator's judgment, would make the participant unsuitable for study participation.

Full record on ClinicalTrials.gov

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