NCT07282457Not 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)
A Prospective, Randomized, Sham-controlled, Dose-finding Phase 1/2 Two-part Trial to Evaluate the Safety, Tolerability, and Efficacy of ZM-02 Injection in Patients With Advanced Retinitis Pigmentosa
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
This is a Phase 1/2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 25 Jun 2026
- Primary completion date
- 25 Dec 2029
- Lead sponsor
- Augelux Therapeutics
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT07282457
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 21
- From 25 Jun 2026 to the primary completion date, 25 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for study participation.
Other
- Pregnant or breastfeeding individuals.
Who the study is looking for
- 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).
Age in the registry: 6 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.