Wet Age-Related Macular Degeneration (wAMD)
Conditions
Interventions
Low-Dose Group:8x1010 vg/eye, 100 µL/eye, single intravitreal injection.
High-Dose Group:2.5×10^11 vg/eye, 100 µL/eye, single intravitreal injection
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form, fully understanding the trial content, procedures, and potential adverse reactions, and willing to undergo follow-up as per the trial's specified timeline and procedures. 2.Age 50 to 80 years(including the boundary value), any gender. 3.Confirmed diagnosis of wAMD and previous history of intravitreal anti-VEGF treatment. 4.Study eye must meet the following criteria: a) Active choroidal neovascularization (CNV) lesion secondary to AMD involving the foveal center or foveal periphery. b) Best-Corrected Visual Acuity (BCVA) =19 letters and =78 letters (equivalent to Snellen visual acuity of 20/400 to 20/32) using the ETDRS chart; c) Received at least 2 anti-VEGF drug injections in the 6 months prior to enrollment. d) Clinically meaningful response to anti-VEGF treatment (defined as a decrease in Central Retinal Thickness (CRT) of =50 µm after previous anti-VEGF treatment). e) Total lesion area (including hemorrhage, scar, and neovascularization) =12 disc areas. f) No media opacities affecting fundus examination and no miotic pupil.
Exclusion criteria
Exclusion criteria: Any of the following ocular conditions: Study eye: 1.Presence of any retinal or choroidal diseases causing choroidal neovascularization (CNV) other than AMD ,or diagnosed polypoidal choroidal vasculopathy (PCV) and deemed unsuitable for inclusion by the investigator. 2.Presence of any other ocular disease (e.g., diabetic retinopathy, pathologic myopia, macular hole) affecting central vision other than wAMD, and deemed unsuitable for inclusion by the investigator. 3.Active ocular infection (e.g., infectious conjunctivitis, keratitis, blepharitis, endophthalmitis, scleritis, uveitis). 4.Uncontrolled glaucoma defined as intraocular pressure >25 mmHg after glaucoma treatment, or severe glaucoma with cup/disc ratio >0.8, or previous glaucoma filtration surgery. 5.Previous or current surgical or laser treatment involving the macula (e.g., photodynamic therapy, macular translocation) ,and deemed unsuitable for inclusion by the investigator. 6.Previous vitrectomy. 7.History of vitreous hemorrhage in the 3 months before screening. 8.Intraocular (periocular) surgery (e.g., trabeculectomy, cataract surgery, YAG posterior capsulotomy, iridotomy, or filtration surgery) or laser treatment (e.g., grating or local photocoagulation) in the 4 weeks before screening. 9.Absence of lens (excluding pseudophakic eyes) or posterior capsular deficiency (excluding eyes with YAG laser posterior capsulotomy after artificial lens implantation). 10.Presence of intraocular implant (excluding intraocular lens) or filler (e.g., steroid implants, silicone oil). 11.Intravitreal/intrachoroidal injection of corticosteroids in the 3 months before screening or long-acting intravitreal implant in the 6 months before screening. 12.Anti-VEGF treatment (e.g., Conbercept, aflibercept, bevacizumab, ranibizumab) in the 4 weeks before randomization. Non-study eye: 13.Non-study eye with functional loss defined as : a) Manual vision or worse BCVA; b) There is no non-study eye (i.e., single eye) Any of the following general conditions: 14.Clinically significant history of allergy or hypersensitivity to fluorescein sodium and indocyanine green, or allergy to therapeutic or diagnostic proteins, or allergy to two or more drugs and/or non-drug factors, or currently having an allergic disease (except mild allergic diseases considered by researchers ,such as allergic rhinitis, pharyngitis). 15.Uncontrolled hypertension defined as systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg after antihypertensive treatment. 16.Documented history of diabetes mellitus, and deemed unsuitable for inclusion by the investigator. 17.Diagnosed systemic autoimmune diseases (e.g., ankylosing spondylitis, systemic lupus erythematosus) or any uncontrolled clinical problem (e.g., AIDS, active hepatitis, severe psychiatric, neurological, cardiovascular, respiratory and other system diseases, and malignant tumors). 18.History of stroke (excluding silent infarcts without clinical symptoms). History of myocardial infarction, cerebrovascular disease, transient ischemic attack, acute coronary syndrome, or coronary revascularization in the 6 months before screening, as well as active disseminated intravascular coagulation and significant bleeding tendency. 19.Surgical history in the 4 weeks before screening ,and deemed unsuitable for inclusion by the investigator. 20.Currently using toxic drugs affecting the lens, retina, or optic nerve (e.g., desferramine, chloroquine, hydroxychloroquine (chloroquin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| anti-VEGF drug supplementation injections; Best-Corrected Visual Acuity (BCVA) ;Central Retinal Thickness (CRT) ;subretinal/intraretinal fluid;CNV vascular density ;CNV subtype;CNV area;National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) scores from baseline; | — |
Countries
China
Contacts
Public ContactYonghao Gu
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed