Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Starting soon Not applicable

ZVS101e in Patients With Bietti's Crystalline Dystrophy

NCT07653971 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-09-30
Last updated
2026-08-24

Condition(s) studied

Bietti's Crystalline DystrophyBietti Crystalline Corneoretinal Dystrophy

Investigational drug(s) / intervention(s)

ZVS101e →

ZVS101e: ZVS101e injection contains a recombinant adeno-associated virus serotype 8 (rAAV8) vector that expresses human CYP4V2 protein.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from baseline in Best corrected visual acuity (BCVA) — From enrollment to the end of treatment at 52 weeks
  • The incidence and severity of adverse events and serious adverse events — From enrollment to the end of treatment at 52 weeks

Trial sites (2)

FacilityCityRegionStatus
Boao Super Hospital Qionghai Hainan
Hainan Boao Ophthalmology Center, Zhongshan Ophthalmic Center, Sun Yat-sen University Qionghai Hainan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07653971 on ClinicalTrials.gov ↗ ← All trials in China