Actively Recruiting
The Safety and Efficacy of ZVS106e in the Treatment of IRDs Caused by Biallelic Mutations in ABCA4
Led by Zhongshan Ophthalmic Center, Sun Yat-sen University · Updated on 2026-04-16
9
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead Sponsor
C
Chigenovo Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the preliminary safety of monocular and single subretinal injection of ZVS106e injection in the treatment of patients with hereditary retinal degeneration (ABCA4-IRDS) caused by ABCA4 biallelic mutations.
CONDITIONS
Official Title
The Safety and Efficacy of ZVS106e in the Treatment of IRDs Caused by Biallelic Mutations in ABCA4
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8 years or older
- Diagnosis of hereditary retinal degeneration caused by ABCA4 biallelic mutations confirmed by genetic testing
- No other ophthalmic genetic diseases
- Best corrected visual acuity in the target eye between 0.5 and 2.0 LogMAR (including 0.5 and 2.0)
- Agreement by patient and spouse to use effective contraception during the trial and for at least one year after treatment
- Voluntary participation with signed informed consent and ability to complete all study procedures as required
You will not qualify if you...
- Current or past other macular lesions in the target eye such as retinal schisis or epiretinal membrane
- Other eye diseases that may interfere with surgery or study results
- Drug treatments affecting study observation within 3 months prior to screening
- Previous intraocular surgeries in the target eye including retinal repositioning and vitrectomy
- Known eye or visual diseases causing vision loss or related treatments that affect vision
- Recent viral infectious diseases or antiviral vaccination within 1 month prior to enrollment
- Use of systemic medications known to cause eye toxicity
- Known allergy to study drugs
- Poorly controlled hypertension (systolic 60 mmHg or diastolic 100 mmHg)
- Significant liver function abnormalities or abnormal coagulation tests
- Positive for active hepatitis B, hepatitis C antibody, HIV antibody, or syphilis antibody
- Medical history that may affect study safety or drug processing, including cardiovascular, liver, kidney, endocrine, digestive, lung, nervous, hematological, tumor, immune, or metabolic disorders
- Participation in other clinical trials within 3 months prior to screening
- Pregnancy or breastfeeding
- Any other condition judged by the investigator to make the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
Research Team
D
dayou Ding
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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