The Safety and Efficacy of ZVS106e in the Treatment of IRDs Caused by Biallelic Mutations in ABCA4 (NCT07241169) | Clinical Trial Compass
RecruitingEarly Phase 1
The Safety and Efficacy of ZVS106e in the Treatment of IRDs Caused by Biallelic Mutations in ABCA4
China9 participantsStarted 2025-12-29
Plain-language summary
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.
Who can participate
Age range8 Years
SexALL
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Inclusion criteria
ā. Age ā„8 years old;
ā. Patients diagnosed with hereditary retinal degeneration caused by ABCA4 biallelic mutations through genetic testing, and without other ophthalmic genetic diseases;
ā. The target eye must meet the following requirements: the best corrected visual acuity is 0.5 to 2.0 LogMAR (including 0.5 and 2.0 LogMAR, equivalent to the decimal visual acuity index up to 0.3);
ā. The subject and his or her spouse agree to take effective contraceptive measures during the trial period and for at least one year after administration.
ā. Voluntarily participate in clinical trials and sign informed consent forms, and be able to complete all trial processes as required by the protocol.
Exclusion criteria
ā. 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;
ā. Having received drug treatment that may affect the observation of the trial within the three months prior to screening;
ā. The target eye has undergone the following intraocular surgeries: retinal repositioning and vitrectomy;
ā. 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;
ā
What they're measuring
1
Evaluate the safety and tolerability of subretinal injection of ZVS106e solution
Timeframe: 52 weeks post-treatment
Trial details
NCT IDNCT07241169
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
. 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;
ā. Systemic medications that are currently in use or may be required to cause eye toxicity, such as psoralen, risselinic acid or tamoxifen, etc.
ā. Known to be allergic to the drugs planned to be used in the study;
ā. Suffering from poorly drug-controlled hypertension: systolic blood pressure ā„160 mmHg or diastolic blood pressure ā„100 mmHg;