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.
Age ≥8 years old;
Patients diagnosed with hereditary retinal degeneration caused by ABCA4 biallelic mutations through genetic testing, and without other ophthalmic genetic diseases;
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);
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.
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;
Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead sponsor
Chigenovo Co., Ltd
Collaborator