nAMD(CNV)
Conditions
Interventions
Cohort 1:Single dose - trial drug intervention -0.6x10^12VG/eye
Cohort 2:Single administration - trial drug intervention - 1.2x10^12VG/eye
Cohort 3:Single administration - trial drug intervention - 2.4x10^12VG/eye
Sponsors
Chinese Academy of Medical Sciences/Henan Provincial Eye Hospital,Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent, able and willing to attend all treatments, trial assessments, and visits as directed. 2. The age of the subjects on the day of signing the informed consent form is between 50~85 years old (including both ends), and the gender is not limited. 3. Subject with a diagnosis of nAMD, at least one eye meets the following criteria: (1) Visual impairment caused by choroidal neovascularization (CNV) of nAMD, with the best corrected visual acuity (BCVA) between 73~19 ETDRS letters (including both ends), and the best corrected visual acuity of the contralateral eye of the study eye >= 19 letters; (2) Subject has received and is currently receiving active intravitreal injection of anti-VEGF drugs (at least 1 intravitreal injection of anti-VEGF injection therapy within 4 months prior to initial screening), and has a clinical response to intravitreal injection therapy of anti-VEGF drugs (such as clinically significant changes confirmed by clinical evidence such as visual acuity or OCT). 4. A clinically significant response to standard therapy for anti-VEGF is defined as at least one of the following at the time of screening for the lead-in treatment period: (1) The CRT value was reduced by >=50µm compared with the screening period; (2) Suboomental or intraretinal effusion decreased by >=30% from the screening period or was judged by the investigator to have significant improvement. 5. Laboratory tests meet the following criteria: (1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 100 g/L (male); Hb>=90 g/L (female); Platelets (PLT) >= 100×10^9/L; (4) Serum creatinine (Cr) and urea nitrogen (BUN) <=1.5×ULN; (5) Glycosylated hemoglobin A1c (HbA1c) <= 10%.
Exclusion criteria
Exclusion criteria: 1. Presence of other fundus diseases other than nAMD in the study eye that may cause the subject to fail to respond to treatment (e.g., severe or proliferative diabetic retinopathy (DR), retinal vein occlusion, retinal detachment, macular hole, etc.). 2. The macular fovea of the study eye has features that affect visual acuity, such as fibrosis, scarring, retinal pigment epithelial tears; or subretinal hemorrhage =50% of the lesion area; or other abnormalities that affect visual acuity improvement (e.g., macular hole, vitreomacular traction syndrome affecting central vision, etc.). 3. The presence of implants (except intraocular lenses), severe turbidity of refractive media, or insufficient dilation of pupils in the study eye, which affects BCVA and surgical operations, resulting in the inability to obtain sufficiently clear ocular imaging data (such as OCT, FFA and fundus photography, etc.), and affects the investigator's observation of safety and efficacy. 4. Photodynamic therapy or fundus laser therapy within 3 months prior to the screening period of the study eye. 5. Retinal detachment in the study eye or previous retinal detachment after repositioning surgery. 6. Previous corneal transplantation, vitrectomy, trabecular mesh resection or other glaucoma surgery in the study eye. 7. History of cataract surgery within 3 months or other intraocular surgery within 6 months in the study eye prior to the administration of the investigational drug; 8. Intravitreal drug injection treatment other than anti-VEGF drugs in the study eye, such as intraocular corticosteroids or any investigational drug, within 6 months prior to the screening period. 9. Uncontrolled elevated intraocular pressure (IOP), defined as glaucoma with IOP greater than 25mmHg despite use of anti-glaucoma medications during the screening period, or requiring control from more than two intraocular antihypertensive medications. 10. History of idiopathic or autoimmune uveitis in the study eye. 11. There is or has scleromalacia in either eye, high myopia (=1000 IU/mL), hepatitis C (positive for hepatitis C antibody and HCV RNA above the lower limit of detection of the analytical method); Positive for human immunodeficiency virus (HIV) antibody or syphilis-specific antibody; Active tuberculosis and other infectious diseases. 20. The subject had uncontrolled blood pressure after adequate antihypertensive treatment (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg in the sitting position), and a single abnormality could be confirmed by repeated measurement. 21. Cerebrovascular accident and/or myocardial infarction occurred within 6 months prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-dose adverse events (AEs) incidence ; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADA Positive ADA rate after administration;The amount of drug in body fluids after administration;The trend of the delivery vehicle in the tissue; The degree to which vision changed after administration; | — |
Countries
China
Contacts
Public ContactSong Zongming/ Dai Rongping
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences/Henan Provincial Eye Hospital
Outcome results
None listed