Not Yet RecruitingPhase 1/2

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

21 participantsStarted 2026-06-25

Plain-language summary

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

Who can participate

Age range6 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

Safety and tolerability of ZM-02

Timeframe: Baseline to Week 52.

Trial details

NCT IDNCT07282457

SponsorZhongmou Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12-25

Contact for this trial

Windy Zhou

+86 18986214263 zmt@zmtherapeutics.com

View on ClinicalTrials.gov More Retinitis Pigmentosa (RP) trials