ZVS101e in Patients With Bietti's Crystalline Dystrophy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChigenovo Co., Ltd
About this trial
The goal of this clinical trial is to evaluate the safety and early effectiveness of ZVS101e in patients with Bietti crystalline dystrophy who meet the eligibility criteria for treatment under the translational application program in the Hainan Boao Lecheng International Medical Tourism Pilot Zone.
Participants will:
undergo screening and baseline assessments to confirm eligibility; receive a single subretinal injection of ZVS101e in the study eye; complete follow-up visits over 4 weeks after treatment for safety monitoring and assessment of early effectiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in the research and sign the informed consent form, and be willing to complete the entire process according to the protocol requirements;
Clinically diagnosed with Bietti's Crystalline Dystrophy (BCD), age ≥ 18 years;
Confirmed by genetic testing to carry homozygous or compound heterozygous mutations in CYP4V2, and not complicated with other ophthalmic genetic diseases;
Target eye BCVA ≤ 60 ETDRS letters.
Disqualifiers
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;
The target eye has previously undergone retinal reattachment surgery, vitrectomy, or any intraocular surgery within 3 months before enrollment;
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;
The target eye has previously received gene therapy or stem cell therapy for BCD or other ocular diseases;
Trial design
Design model
Single group
Treatments tested in this trial
ZVS101e
DrugZVS101e injection contains a recombinant adeno-associated virus serotype 8 (rAAV8) vector that expresses human CYP4V2 protein.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: ZVS101e Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Best corrected visual acuity (BCVA)
Time frame
From enrollment to the end of treatment at 52 weeks2
The incidence and severity of adverse events and serious adverse events
Time frame
From enrollment to the end of treatment at 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: