Naive Neovascular Age-Related Macular Degeneration
Conditions
Interventions
Treatment group:Aflibercept 8mg
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 50 years; 2. Patients diagnosed with nAMD; 3. Naïve patients with nAMD who should not have been exposed to any prior drug (and/or laser treatment) to treat their underlying disease; 4. Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws); 5. Patients have good compliance assessed by the investigator. 6. If both eyes meet the enrollment criteria, the study eye shall be selected in accordance with the following rules: a. If the best-corrected visual acuity (BCVA) differs between the two eyes, the eye with poorer visual acuity will be chosen; b. If the BCVA of both eyes is identical, the right eye will be designated as the study eye by default.
Exclusion criteria
Exclusion criteria: 1. Patients who participated in any other interventional clinical study involving either eye within 28 days prior to screening, including, but not limited to, any intraocular surgery or intravitreal anti-VEGF treatment. 2. Intraocular pressure (IOP) > 25 mmHg at screening. 3. Patients who underwent panretinal photocoagulation (PRP) or focal/grid macular laser photocoagulation within 12 weeks (84 days) prior to screening. 4. Patients with a history of vitreoretinal surgery (including scleral buckling) or glaucoma filtration surgery in the study eye, or who are likely to require filtration surgery during the study period. 5. Patients with contraindications to aflibercept, including hypersensitivity to aflibercept or any of its excipients, ocular or periocular infections, or severe active intraocular inflammation. 6. Study eyes that received intravitreal corticosteroid treatment within 3 months prior to screening. 7. Study eyes containing any sustained-release drug delivery implant. 8. Patients whose fellow eye has diabetic retinopathy (DR), diabetic macular edema (DME), or any retinal vascular disease other than neovascular age-related macular degeneration (nAMD). 9. Study eyes with uncontrolled glaucoma, defined as an intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medications. 10. Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of decrease in the number of HRF from baseline to week 12;The percentage of stable in the number of HRF from baseline to week 12;The changes in the number of HRF in different locations from baseline to week 12; | — |
Countries
China
Contacts
Public ContactYufeng Xu
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed