Active — Not RecruitingPhase 3

Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy

China62 participantsStarted 2024-12-27

Plain-language summary

This is a multi-center, randomized and controlled phase 3 clinical trial.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All of the following inclusion criteria should be met for enrollment into the trial:
. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the informed consent form, and be able to complete all trial procedures as required by the protocol;
. Clinical diagnosis of Bietti's crystalline dystrophy (BCD), age≥18 years ;
. Genetic testing confirmed biallelic CYP4V2 mutations without other ophthalmic genetic diseases;
. Best-corrected visual acuity of 5-60 ETDRS letters.

Exclusion criteria

. The study eye has or has had macular lesions such as macular hole or macular neovascularization; glaucoma, diabetic retinopathy, or any other ocular disease that may preclude surgery or interfere with interpretation of the study endpoints
. The study eye had received the following intraocular surgical treatments: retinal reattachment, vitrectomy;
. The study eye had received any intraocular surgery, such as phacoemulsification 3 months prior to enrollment;
. Previously treatment of either eye with gene therapy or stem cell therapy for BCD and other ocular diseases, including but not limited to viral vector gene therapy, RNA therapy;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of study eyes with a ≥15-letter improvement from baseline in BCVA

Timeframe: From baseline to Week 52

Trial details

NCT IDNCT06743646

SponsorChigenovo Co., Ltd

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Bietti Crystalline Corneoretinal Dystrophy trials