Neovascular age-related macular degeneration (nAMD),Polypoidal choroidal vasculopathy (PCV)
Conditions
Interventions
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 50 years, any gender; 2. Definition of PCV group: study eye has not received ocular anti-VEGF treatment in the past 3 months; 3. Definition of nAMD group: study eye has not received ocular anti-VEGF treatment in the past 3 months; 4. Definition of study eye diagnosed with nAMD is as follows: FFA or OCTA shows active macular neovascular lesions, with activity determined using multimodal imaging. Active lesions are defined as the presence of any of the following in the macular area: (1) Intraretinal fluid; (2) Intraretinal lipid exudate; (3) Subretinal fluid; (4) Subretinal hemorrhage; (5) Retinal pigment epithelium detachment; (6) Choroidal neovascular leakage; 5. Definition of study eye diagnosed with PCV is as follows: ICGA or OCTA shows active macular polypoidal lesions, with activity determined using multimodal imaging. According to the new OCT criteria recommended by the Asia-Pacific Ophthalmic Imaging Society PCV Working Group, the PCV diagnostic pattern uses the "3+1" standard: Three major diagnostic criteria: (1) Sub-RPE ring-shaped lesions; (2) Enface OCT RPE elevation; (3) Sharp PED peak; Four minor diagnostic criteria: (1) Orange-red nodules; (2) Choroidal thickening with dilated Haller’s layer vessels; (3) Complex/multilobular PED; (4) Double-layer sign.
Exclusion criteria
Exclusion criteria: 1. The study eye and the whole body have received any of the following treatments within the 3 months prior to randomization: verteporfin photodynamic therapy (PDT), macular laser photocoagulation, transpupillary thermotherapy (TTT), other surgeries used to treat AMD or PCV, or a history of systemic anti-VEGF therapy; 2. The study eye has previously undergone the following ophthalmic surgeries: vitrectomy, anti-glaucoma surgery, macular translocation surgery; 3. The study eye has received intravitreal treatment (such as corticosteroids or medical device implants) within the 3 months prior to randomization, or any intraocular, periocular, or subconjunctival long-acting corticosteroid injection (e.g., triamcinolone) within 1 month prior to randomization; 4. The study eye has coexisting ocular diseases affecting central vision (e.g., diabetic retinopathy, retinal vein occlusion, uveitis, vascular sheathing, pathological myopia, retinal detachment, macular hole, epiretinal membrane, coloboma, optic nerve diseases); 5. The study eye has a history of choroidal neovascularization not caused by nAMD or PCV; 6. The study eye has a refractive error with a spherical equivalent exceeding -6.0 diopters. For patients with a history of refractive or cataract surgery, the preoperative refractive error of the study eye should not exceed -6.0 diopters; 7. The study eye is aphakic (excluding eyes with an intraocular lens) or has a posterior capsule rupture (except YAG posterior capsulotomy performed more than 1 month after intraocular lens implantation); 8. The study eye has uncontrolled glaucoma at the time of randomization, defined as intraocular pressure remaining >25 mmHg despite medication; 9. Any eye has a history of idiopathic or autoimmunity-related uveitis; 10. Currently using or potentially requiring systemic medications that may cause lens or retinal toxicity, such as desferrioxamine, chloroquine/hydroxychloroquine, phenothiazines, ethambutol, or tamoxifen, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of proteins identified; | — |
Countries
China
Contacts
Public ContactXiaorong Li
Tianjin Medical University Eye Hospital
Outcome results
None listed