Experimental eye injection aims to slow vision loss in rare disease
NCT ID NCT06292650
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests the safety of a new drug called ZM-02, given as an injection into one eye, in 12 adults with retinitis pigmentosa—a genetic condition that causes gradual vision loss. The main goal is to check for side effects, not to cure the disease. Researchers will also measure if the injection helps patients see better in dim light.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Patients who meet all of the following criteria can be selected as subjects: 1. Clinically diagnosed with retinal pigment degeneration 2. The visual acuity of study eye is no better than the finger counting, while the visual acuity of the study eye is not better than that of the contralateral eye 3. The subject has had visual experience above the finger counting 4. In the OCT examination of the tested eye, the disappearance of the ellipsoid zone is observed, but the inner nuclear layer and the nerve fiber layer of the retina are still present 5. The refractive power of the tested eye is between -6.00 D and +6.00 D 6. Not infected with the Human Immunodeficiency Virus (HIV) and other acute and chronic infectious diseases 7. Voluntarily sign an Informed Consent Form (ICF), and the age is not less than 18 years and not more than 65 years 8. Able to fully understand and agree to cooperate with the implementation of the research protocol Exclusion Criteria: Subjects who meet any one of the following exclusion criteria will be excluded from the study: 1. Pregnant women, breastfeeding women, or male and female subjects who do not agree to contraception during the 12 months before and after medication 2. Subjects with narrow anterior chamber angles or any other medical conditions that contraindicate pupil dilation 3. Subjects allergic to corticosteroids, who are unable to tolerate the corticosteroid treatment described in the protocol, or have active 4. concurrent infections that contraindicate treatment 4. Subjects with systemic diseases, or other medical or mental illnesses, or other safety concerns for the study 5. Subjects with other symptoms and/or diseases or conditions that can alter visual function, including but not limited to glaucoma and central nervous system lesions (mild cataracts are not included in this restriction) 6. Eye diseases that may interfere with the assessment of vision during the study and/or interfere with other ocular assessments such as OCT 7. Diseases that may affect the clinical trial, such as tumors, metabolic, immune-related diseases, etc. 8. Subjects who have undergone major eye surgery within the last 3 months before screening 9. Subjects with a history of malignant tumors within the last 5 years 10. Subjects with other retinal diseases not suitable for this study, such as retinal detachment 11. Patients undergoing or potentially undergoing immunosuppressive treatment for other diseases, excluding this study 12. Participation in any clinical trials other than this study within the last 3 months 13. Subjects who have received gene therapy outside of this study 14. Other reasons deemed by the researcher as unsuitable for participation in this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tongren Hospital of Capital Medical University
RECRUITINGBeijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a single eye injection restore sight in genetic blindness?
- A sharper look at the retina: new imaging technology may spot eye disease earlier
- Stem cell eye transplant aims to halt blindness from rare genetic disease
- Could stem cells restore sight in damaged eyes?
- Gene therapy injection aims to restore sight in rare blindness
- Ground-Level vision test could help retinitis pigmentosa patients walk better