wAMD
Conditions
Interventions
Group 1:Injection of low dose
Group 2:Injection of medium dose
Group 3:Injection of high dose
Sponsors
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patinets = 50 years and = 80 years old, no gender limit. 2) The study eye was diagnosed with subfoveal active CNV lesions secondary to nAMD (including parafoveal lesions involving the fovea) 3) BCVA of tudy eye during screening: Dose increasing stage (Phase I), ETDRS letters= 63 and = 19; Dose extension stage (Phase IIa), ETDRS letters= 73 and = 34. 4) The subjects have previously received and are currently receiving intravitreal injection of anti VEGF injections, and response to anti VEGF injections. 5) Response to Arbacicept during screening. 6) If both eyes meet the screening criteria, the more severe eye will be selected as the study eye; If both eyes have the same condition, choose the right eye as the research eye. 7)The subjects did not plan to undergo ophthalmic surgery during the study period. 8) Male or female subjects with reproductive potential are willing to take effective contraceptive measures during signing the ICF and 1 year after the injection of AL-001 ophthalmic surgery. Female patients with fertility had a negative blood pregnancy test result within 14 days before enrollment. 9) The subject or their legal representative agrees to participate in this study and signs a written ICF. 10) The subjects are willing and able to follow planned visits, treatment plans, and other research procedures.
Exclusion criteria
Exclusion criteria: 1)Non-wAMD induced CNV or macular edema in the study eye. 2) Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye, including but not limited to: macular diseases (GA, scar or fibrosis involving the fovea, macular hole, epimacular membrane, vitreomacular traction syndrome, Retinal pigment epithelium tear involving the macular center, etc.); Diabetic retinopathy, retinal vein occlusion, Retinal detachment, viral retinitis, optic neuropathy, etc. 3) Retinal photodynamic therapy or laser photocoagulation therapy in the macular region, or local eye radiation therapy in the study eye. 4) Uncontrolled glaucoma in the study eye (IOP = 25 mmHg after treatment with two or more local anti glaucoma drugs). 5) History of vitreoretinal surgery, anti glaucoma trabeculectomy, or other anti glaucoma filtering surgery in the study eye. 6) History of local injection of any glucocorticoid hormone in the study eye in 3 months prior to signing the ICF (e.g. subconjunctival, parabulbar, retrobulbar injection or intravitreal injection, SCS injection); history of glucocorticoid hormone intravitreal implants (e.g. Ozurdex® ) in the study eye in 6 months prior to signing the ICF; history of Yutiq ®. 7) History of any intraocular or major periocular surgery in the study eye in 3 months prior to signing the ICF (Within 30 days before signing the ICF for YAG laser posterior capsulotomy, iridectomy, or trabeculectomy; excluding intravitreal injection of anti VEGF drugs). 8) Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye. 9) Ametropia (high myopia or high hyperopia) > 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye. 10) Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma. 11) Noninfective intraocular inflammation in the study eye. 12) Active infective eye inflammation or infection in 30 days before signing the ICF in any eye. 13) Implants (except intraocular lens) in the study eye during screening. 14) Any intraocular clinical trial treatment or investigational drugs for wAMD (excluding dietary supplements, vitamins or minerals) in 6 months prior to signing the ICF. 15) BCVA <19 ETDRS letters in any eye. 16)Concomitant therapy or need to receive systemic drugs that may cause retinal toxicity, such as deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazine, ethambutol, etc. 17) Known hypersensitivity to fluorescein and indocyanine green, or biological products, or investigational products or their components. 18) Systemic application of anti VEGF therapy within 90 days prior to enrollment. 19) Participation in any other gene therapy study. 20) Any infective diseases requiring anti-infective treatment (oral, intramuscular or intravenous). 21) Diabetes patients with uncontrolled blood glucose (fasting plasma glucose = 7.0 mmol/L or 2h postprandial plasma glucose = 11.1 mmol/L). 22) Poorly controlled hypertension (systolic blood pressure = 160) 23) Heart failure that meets any of the following definitions: symptomatic congestive heart failure (CHF) with CTCAE v5.0 grade = 3 or a history of New York Heart Association (NYHA) standard = 2, left ventricular ejection fraction<50% on echocardiography, history of transmural myocardial infarction, angina requiring medication, severe arrhythmia without sufficient medication con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity;Central Retinal Thickness;Anti-VEGF injection;Choroidal neovascularization area;Pharmacokinetics;Immunogenicity;Virus shedding; | — |
Countries
China
Contacts
Public ContactChen Youxin
Chinese Academy of Medical Sciences & Peking Union Hospital
Outcome results
None listed