Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)
NCT ID: NCT07282457
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2026-02-25
2031-12-25
Brief Summary
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Detailed Description
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This Phase 1/2 study is designed to evaluate the safety, tolerability, and preliminary efficacy of a single unilateral intravitreal injection of ZM-02 at escalating dose levels in patients with advanced RP. The study includes a sham-controlled design and will assess safety outcomes as well as multiple functional and structural measures of visual performance over long-term follow-up.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose ZM-02
ZM-02 (low dose)
Single unilateral IVT injection of low-dose ZM-02 in the study eye
High Dose ZM-02
ZM-02 (high dose)
Single unilateral IVT injection of high-dose ZM-02 in the study eye
ZM-02 (selected dose)
ZM-02 (selected dose)
Single unilateral IVT injection of selected-dose ZM-02 in the study eye
Sham Comparator
Sham injection
Sham IVT procedure in the study eye
Interventions
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ZM-02 (low dose)
Single unilateral IVT injection of low-dose ZM-02 in the study eye
ZM-02 (high dose)
Single unilateral IVT injection of high-dose ZM-02 in the study eye
ZM-02 (selected dose)
Single unilateral IVT injection of selected-dose ZM-02 in the study eye
Sham injection
Sham IVT procedure in the study eye
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of advanced retinitis pigmentosa (RP).
3. Best corrected visual acuity at or below the protocol-defined threshold in the study eye.
4. Presence of sufficient retinal structure in the study eye as determined by screening assessments.
5. Ability to understand and sign informed consent (and assent, when applicable).
Exclusion Criteria
2. History of significant ocular surgery in the study eye within a protocol-defined period.
3. Active ocular infection or inflammation.
4. Clinically significant systemic disease that could increase study risk or interfere with assessments.
5. Positive screening for clinically significant infectious diseases, as defined in the protocol.
6. Pregnant or breastfeeding individuals.
7. Any condition that, in the investigator's judgment, would make the participant unsuitable for study participation.
6 Years
60 Years
ALL
No
Sponsors
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Zhongmou Therapeutics
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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ZM-02-201
Identifier Type: -
Identifier Source: org_study_id
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