Wet age-related macular degeneration
Conditions
Interventions
Group A(1 Type MNV):None
Group B(2 Type MNV):None
Group C(3 Type MNV):None
Group D (Hybrid MNV):None
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: Group A (Type 1 MNV) 1) aged from 55 to 80 years old; 2) Type 1 MNV confirmed by FFA and OCT: 3) have not received any anti-VEGF therapy, PDT therapy, laser photocoagulation, or intraocular hormone therapy for MNV; 4) No subretinal fibrosis was confirmed by fundus photography, FFA and OCT before enrollment. Definition of subretinal fibrosis: The definition of subretinal fibrosis was modified according to CATT criteria 26 and in combination with recent advances in SHRM (subretinal hyperreflective substance) research. In this study, subretinal fibrosis was defined as a prominent yellow or white fibrous tissue with clear shape and solid appearance under ophthalmoscopy. It has a clear appearance of fibrous shape on color stereoscopic images, and hyperfluorescence characteristics of scar staining on FFA examination, and hyperreflective echogenic lesions with or without pruned vascular trees, tangled vascular networks and/or vascular rings on OCT/OCTA examination (based on multimodal imaging and SHRM). 5) BCVA between 24 and 75 letters (including EDTRS chart) (20/32-20/320 Snellen chart); 6) patients with a clinical diagnosis of wet AMD requiring anti-VEGF therapy 7) voluntarily provide written informed consent and comply with the visit and related inspection procedures specified in the protocol; For subjects of childbearing age, agree to take effective contraceptive measures; 8) did not participate in other clinical studies. Group B (type 2 MNV) 1) aged from 55 to 80 years old; 2) Type 1 MNV confirmed by FFA and OCT: 3) have not received any anti-VEGF therapy, PDT therapy, laser photocoagulation, or intraocular hormone therapy for MNV; 4) No subretinal fibrosis was confirmed by fundus photography, FFA and OCT before enrollment. Definition of subretinal fibrosis: The definition of subretinal fibrosis was modified according to CATT criteria 26 and in combination with recent advances in SHRM (subretinal hyperreflective substance) research. In this study, subretinal fibrosis was defined as a prominent yellow or white fibrous tissue with clear shape and solid appearance under ophthalmoscopy. It has a clear appearance of fibrous shape on color stereoscopic images, and hyperfluorescence characteristics of scar staining on FFA examination, and hyperreflective echogenic lesions with or without pruned vascular trees, tangled vascular networks and/or vascular rings on OCT/OCTA examination (based on multimodal imaging and SHRM). 5) BCVA between 24 and 75 letters (including EDTRS chart) (20/32-20/320 Snellen chart); 6) patients with a clinical diagnosis of wet AMD requiring anti-VEGF therapy 7) voluntarily provide written informed consent and comply with the visit and related inspection procedures specified in the protocol; For subjects of childbearing age, agree to take effective contraceptive measures; 8) did not participate in other clinical studies. Group C (type 3 MNV) 1) aged from 55 to 80 years old; 2) Type 1 MNV confirmed by FFA and OCT: 3) had not received any anti-VEGF therapy, PDT therapy, laser photocoagulation, or intraocular hormone therapy for MNV Treatment; 4) No subretinal fibrosis was confirmed by fundus photography, FFA and OCT before enrollment. Definition of subretinal fibrosis: The definition of subretinal fibrosis was modified according to CATT criteria 26 and in combination with recent advances in SHRM (subretinal hyperreflective substance) research. In this study, subretinal fibrosis was defined as a prominent yellow or white fib
Exclusion criteria
Exclusion criteria: Group A (Type 1 MNV) 1) The target eye had scarring, fibrosis, atrophy, subfoveal hard exudation, or retinal pigment epithelial tears involving the macula; 2) the target eye had received any intraocular surgery (including laser, intraocular hormone, intraocular implant, cataract surgery, etc.) in the past three months; 3) the target eye was aphakia (except intraocular lens); 4) active eye diseases, such as conjunctivitis, keratitis, uveitis and scleritis; 5) patients with any ocular diseases or history other than nAMD that affect central vision and/or macular examination, such as glaucoma, pathological myopia, history of retinal detachment or other intraocular diseases such as active retinal detachment, macular hole, epiretinal membrane, diabetic retinopathy and amblyopia; 6) The target eye has mydriasis disorder affecting the fundus examination; 7) patients allergic to any of the study drugs such as fluorescein sodium or indocyanine green; 8) patients with systemic immune diseases, including but not limited to Behcet's disease, SLE syndrome and rheumatoid arthritis; 9) patients with uncontrolled systemic disease: e.g., poorly controlled hypertension (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg in two consecutive measurements). , diabetes (glycosylated hemoglobin >10%), kidney disease, serious mental, neurological, cardiovascular, respiratory and immune system diseases; 10) occurrence of cardio-cerebrovascular events (such as myocardial infarction, etc.) and other thromboembolic diseases (such as thromboangiitis, pulmonary embolism, etc.) within 6 months before the first dose; Patients with disseminated intravascular coagulation and major bleeding tendency before the first administration; Or patients judged by physicians to be unsuitable for intravitreal injection of anti-VEGF drugs; 11) had a history of major surgical trauma within 3 months before the first dose; Or those with unhealed wounds, ulcers, fractures, etc., and potential risks as judged by the researchers; 12) patients diagnosed with malignancy within 5 years before the first dose; 13) excluded other types of MNV 14) Others: inability to comply with study or follow-up procedures or other conditions deemed by the investigator to be ineligible for enrollment. Group B (type 2 MNV) 1) The target eye had scarring, fibrosis, atrophy, subfoveal hard exudation, or retinal pigment epithelial tears involving the macula; 2) the target eye had received any intraocular surgery (including laser, intraocular hormone, intraocular implant, cataract surgery, etc.) in the past three months; 3) the target eye was aphakia (except intraocular lens); 4) active eye diseases, such as conjunctivitis, keratitis, uveitis and scleritis; 5) patients with any ocular diseases or history other than nAMD that affect central vision and/or macular examination, such as glaucoma, pathological myopia, history of retinal detachment or other intraocular diseases such as active retinal detachment, macular hole, epiretinal membrane, diabetic retinopathy and amblyopia; 6) The target eye has mydriasis disorder affecting the fundus examination; 7) patients allergic to any of the study drugs such as fluorescein sodium or indocyanine green; 8) patients with systemic immune diseases, including but not limited to Behcet's disease, SLE syndrome and rheumatoid arthritis; 9) patients with uncontrolled systemic disease: e.g., poorly controlled hypertension (systolic blood pressure >=160mmHg and/o
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Microperimetry;Optical Coherence Tomography Angiography;Color Fundus Photography;Indocyanine Green Angiography;Intraocular pressure(IOP);Best corrected visual acuity;Optical Coherence Tomography;Multifocal Electroretinogram;Fundus Fluorescein Angiography; | — |
Countries
China
Contacts
Public ContactKunbei Lai
Zhongshan Ophthalmic Center, Sun Yat-sen University
Outcome results
None listed