Trials Sponsors Conditions Drugs Pricing

Conditions

Stargardt

Keywords

ZVS106e

Outcome Measures

Primary Outcomes (1)

Evaluate the safety and tolerability of subretinal injection of ZVS106e solution
Types, severity, and incidence of adverse events (AE) and serious adverse events (SAE) in the eyes and throughout the body within 52 weeks post-treatment, including dose-limiting toxicities (DLT) during the dose escalation phase.
52 weeks post-treatment

Secondary Outcomes (4)

Change from baseline in best-corrected visual acuity (BCVA)
52 weeks post-treatment
Change from Baseline in Visual function metrics
52 weeks post-treatment
Change from Baseline in OCT
52 weeks post-treatment
Change from Baseline in Fundus autofluorescence (FAF)
52 weeks post-treatment

Study Arms (1)

Single arm

EXPERIMENTAL

All patients enrolled in the study will receive a single subretinal injection of ZVS106e in one eye

Drug: ZVS106e

Interventions

ZVS106eDrug

ZVS106e is A colorless, clear and transparent liquid, containing two active ingredients, ZVS106E-A and ZVS106E-B. The viral vectors used for both active ingredients are rAAV8

Also known as: rAAV8

Single arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age8 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Age ≥8 years old;
Patients diagnosed with hereditary retinal degeneration caused by ABCA4 biallelic mutations through genetic testing, and without other ophthalmic genetic diseases;

Sponsors & Collaborators

Chigenovo Co., Ltd
Research networkcollaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Otherlead

Study Sites (2)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Jinlu Zhang, MDCONTACT+86-15810570898 zhangjinlu@chinagene.cc

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

NOT_YET_RECRUITING

Jinlu Zhang, MDCONTACT+86-15810570898

Study Officials

qingjiong zhang, M.D
PI
STUDY DIRECTOR
lin Lv, M.D
PI
PRINCIPAL INVESTIGATOR

Central Study Contacts

dayou Ding

CONTACT

010-82266699 dingdayou@chinagene.cc

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: PI

Study Record Dates

First Submitted

September 29, 2025

First Posted

November 21, 2025

Study Start

December 29, 2025

Actual (reported)

Primary Completion

November 30, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

The researchers determined that the target eye currently has or has previously had other macular lesions such as retinal schisis or epiretinal membrane. Or have other eye diseases that may hinder the surgery or interfere with the interpretation of the study endpoint;
Having received drug treatment that may affect the observation of the trial within the three months prior to screening;
The target eye has undergone the following intraocular surgeries: retinal repositioning and vitrectomy;
There are known eye/visual diseases, disorders or lesions that cause or are related to vision loss, or whose related treatments or therapies are known to cause or are related to vision loss;
Having suffered from a viral infectious disease that may affect the efficacy and safety evaluation of the investigational drug or having received an antiviral vaccine within one month prior to enrollment;
Systemic medications that are currently in use or may be required to cause eye toxicity, such as psoralen, risselinic acid or tamoxifen, etc.
Known to be allergic to the drugs planned to be used in the study;
Suffering from poorly drug-controlled hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg;
The following laboratory test abnormalities have clinical significance:
Liver function: Chronic liver disease, elevation of ALT or AST \>2 times the upper limit of the normal value; Those with abnormal coagulation function (prothrombin time ≥ 3 seconds above the upper limit of the normal value, activated partial thromboplastin time ≥ 10 seconds above the upper limit of the normal value); Serum virological examination: Positive for active hepatitis B, hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or syphilis antibody;
There is any past or current medical history that may affect the safety of the trial or the in vivo process of the drug, especially a history of diseases such as cardiovascular, liver, kidney, endocrine, digestive tract, lung, nervous, hematological, tumor, immune or metabolic disorders that the investigators consider to have clinical significance;
Those who have participated in any clinical trials of drugs or medical devices within the three months prior to screening;
Pregnant or lactating women; According to the researcher's judgment, those who are deemed unsuitable to participate in this clinical trial for other reasons

The Safety and Efficacy of ZVS106e in the Treatment of IRDs Caused by Biallelic Mutations in ABCA4

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Single arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Single arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations