Untreated nAMD with active subfoveal choroidal neovascularization (CNV), where the total area of CNV accounts for more than 50% of the total lesion area.
Conditions
Interventions
Treatment group:Aflibercept 8mg intravitreal injection treatment
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients who fully understand the content, process, and possible AEs of this study, and can provide written informed consent; 2. Men or women aged 50 or older when signing the informed consent form; 3. Women of childbearing potential (WOCBP) must agree to use two forms of contraception during the study and for 4 months after stopping the study treatment, which means using one medically recognized method with a yearly failure rate of less than 1% together with a barrier method (like condoms). Women who have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or have been postmenopausal for over a year are considered not capable of conceiving. Women of childbearing potential must have a negative pregnancy test at screening and must not become pregnant, breastfeed, lactate, or plan pregnancy, breastfeeding, or egg donation during the study and for 4 months after stopping the study treatment; 4. All male participants who have female partners of childbearing potential must agree to use two forms of contraception during the study and for four months after the treatment ends—that is, one medically recognized method with an annual failure rate of less than 1% combined with a barrier method (such as condoms). They must also agree not to donate sperm during the study and for four months after the treatment ends; 5. Having clear enough eye media and fully dilated pupils to get high-quality retinal images for diagnosis; 6. Untreated nAMD with active subfoveal choroidal neovascularization (CNV), where the total area of CNV accounts for more than 50% of the total lesion area; 7. The SD-OCT scan shows fluid inside the retina (IRF) and/or under the retina (SRF) in the center of the macula; 8. During the screening and baseline period, the BCVA score was measured using the ETDRS eye chart at an initial testing distance of 4 meters, ranging from 78 to 24 ETDRS letters (approximately equivalent to Snellen vision 20/32 to 20/320), and the vision loss was caused by nAMD.
Exclusion criteria
Exclusion criteria: 1. Patients who have received other investigational treatments (including anti-VEGF, corticosteroids, laser photocoagulation therapy—either panretinal or macular—or photodynamic therapy (PDT)) or already approved nAMD drugs/treatments; 2. Patients who are allergic or hypersensitive to any ingredients/excipients in the formulation; 3. Uncontrolled high blood pressure (defined as a systolic BP >160 mmHg or diastolic BP >95 mmHg). Participants can be on up to three antihypertensive medications that are known to lower blood pressure in order to achieve adequate control. This limit applies to any medications that can be used to treat high blood pressure, even if the participant is taking them for reasons other than controlling blood pressure. Any medication known to affect blood pressure must have been taken at a stable dose for the 12 weeks prior to screening; 4. Having a history of other diseases, metabolic dysfunction, abnormal physical exam findings, or unusual clinical lab results, with reasonable grounds to suspect conditions that could make using the experimental drug unsafe, affect the interpretation of study results, or put the patient at high risk of treatment complications; 5. Any situation that a researcher thinks might affect a patient signing the informed consent, following the study plan, completing the trial according to the process, or where the patient's participation might impact the trial results or their own safety; 6. Any eye with diabetic retinopathy (DR), diabetic macular edema (DME), or any retinal vascular disease other than nAMD; 7. During the screening or baseline period, either eye has an external/periocular infection or inflammation; 8. Presence of retinal pigment epithelium (RPE) tears or ruptures, scarring, fibrosis, or atrophy involving the macula; 9. Fluorescein angiography (FA) / fundus photography (FP) shows: (1) The total lesion area (including hemorrhage, scarring, and neovascularization) is greater than 12 disc areas (30.5 mm^2); (2) Fibrosis or atrophy >50% of the total lesion area, and/or involvement of the fovea; 10. Researchers believe there may be any intraocular diseases that could reduce vision improvement or require medical or surgical intervention during the study (such as amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction): (1) Vitreous hemorrhage present during the screening or baseline period; (2) Uncontrolled glaucoma (intraocular pressure > 25 mmHg despite using anti-glaucoma medications); (3) Received any cataract surgery or steroid or YAG laser posterior capsulotomy for cataract surgery complications within 3 months before Day 1 of the study; (4) Previously had any other intraocular surgery (e.g., vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy); (5) Prior periocular drug or intravitreal injection treatment for other retinal diseases (including anti-VEGF drugs); (6) Intraocular inflammation/infection in either eye within 12 weeks before the screening visit; (7) History of idiopathic or autoimmune-related uveitis in the study eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aqueous humor VEGF-A; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central retinal thickness (CMT);Best vision correction;The percentage of patients with no intraretinal fluid (IRF) or subretinal fluid (SRF) in the foveal area at month 0, 2, and 12;Average number of doses;Proportion of patients who haven't received remedial treatment;Interleukin-6 (IL-6);Vascular endothelial growth factor B (VEGF-B);Average area of macular neovascularization (MNV);Placental growth factor (PIGF);Interleukin-8 (IL-8);Angiopoietin-2 (Ang-2); | — |
Countries
China
Contacts
Public ContactLi Xiaorong
Tianjin Medical University Eye Hospital
Outcome results
None listed