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One-Time gene injection aims to halt rare blindness

NCT ID NCT07653971

Disease control Sponsor: Chigenovo Co., Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This trial tests a single injection of a gene therapy called ZVS101e for people with Bietti crystalline dystrophy, a rare inherited eye disease that leads to progressive vision loss. The therapy uses a harmless virus to deliver a working copy of the CYP4V2 gene to cells in the eye. Participants receive one injection in the study eye and are followed for 4 weeks to check safety and early signs of effectiveness.

What this could mean

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

Active substance
ZVS101e (a gene therapy injection using a harmless virus to deliver a working copy of the CYP4V2 gene)
What this could lead to
If successful, this could provide a treatment option for people with Bietti crystalline dystrophy, potentially slowing vision loss or improving sight.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not apply to everyone. Gene therapy carries risks like inflammation or retinal damage.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 years and older

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. Voluntarily participate in the research and sign the informed consent form, and be willing to complete the entire process according to the protocol requirements; 2. Clinically diagnosed with Bietti's Crystalline Dystrophy (BCD), age ≥ 18 years; 3. Confirmed by genetic testing to carry homozygous or compound heterozygous mutations in CYP4V2, and not complicated with other ophthalmic genetic diseases; 4. Target eye BCVA ≤ 60 ETDRS letters. Exclusion Criteria: Subjects will be excluded if they meet any 1 of the following exclusion criteria: 1. The target eye currently has or has a history of macular lesions; suffers from ocular diseases that may hinder surgery or interfere with the interpretation of study endpoints; 2. The target eye has previously undergone retinal reattachment surgery, vitrectomy, or any intraocular surgery within 3 months before enrollment; 3. Within 1 month before enrollment, suffered from viral infectious diseases that may affect the evaluation of the efficacy and safety of the investigational drug, or received antiviral vaccines; 4. The target eye has previously received gene therapy or stem cell therapy for BCD or other ocular diseases; 5. Known allergy to the drugs planned for use in the study; 6. The laboratory abnormalities are considered clinically significant; 7. Pregnant or lactating females.

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Conditions

The condition(s) this trial relates to.

Bietti crystalline corneoretinal dystrophy

As listed by the trial registrant

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

Bietti crystalline corneoretinal dystrophy Bietti's crystalline dystrophy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Boao Super Hospital

    Qionghai, Hainan, China

  • Hainan Boao Ophthalmology Center, Zhongshan Ophthalmic Center, Sun Yat-sen University

    Qionghai, Hainan, China

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