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Gene therapy injection aims to save sight in rare eye disease

NCT ID NCT07282457

Disease control Sponsor: Zhongmou Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a single injection of ZM-02, a gene therapy, in 21 people aged 6 to 60 with advanced retinitis pigmentosa, a genetic condition that causes progressive vision loss. Participants are randomly assigned to receive either a low or high dose of ZM-02 or a sham injection. The study primarily checks safety and tolerability, while also measuring changes in visual acuity, mobility in low light, and quality of life over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZM-02 (gene therapy injection)
What this could lead to
If successful, this could point toward a treatment that slows or partially reverses vision loss in retinitis pigmentosa.
What could go wrong
This is an early phase 1/2 trial with only 21 people, so results may not apply widely. Gene therapies can have side effects like inflammation, and the sham control means some may not receive the active treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Male or female participants aged 6 to 60 years. 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 1. Presence of other ocular conditions that could interfere with study assessments. 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.

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Conditions

The condition(s) this trial relates to.

retinitis pigmentosa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinitis pigmentosa (RP)

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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