Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03169660
Eligibility Criteria:
Inclusion Criteria:
1. 50 years of older
2. Newly diagnosed, treatment-naïve exudative AMD
3. Fovea-involving submacular hemorrhage greater than 1 disc areas at diagnosis
Exclusion Criteria:
1. History of previous treatment for neovascular AMD
2. Greater than 15 disc diameter areas of hemorrhage extent
3. History of vitreoretinal surgery
4. History of glaucoma surgery, such as trabeculectomy or glaucoma implant surgery
5. History of ocular steroid injection therapy within 1 month
6. History of cataract surgery within 3 months
7. Aphakia or anterior chamber intraocular lens implantation
8. Spherical equivalents greater than -6.0 diopters
9. evidence of other retinal disorders that may affect visual function including diabetic retinopathy, hypertensive retinopathy, epiretinal membrane, macular hole, and microaneurysm
10. severe media opacity
11. uncontrolled systemic disorders, including hypertension or diabetes mellitus
12. history of major systemic vascular events, such as myocardial infarction and stroke
13. hypersensitivity to aflibercept
14. ocular or periocular infection
15. active intraocular inflammation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03169660
Study Brief:
Protocol Section:
NCT03169660