Intravitreal Aflibercept for Submacular Hemorrhage

• Status: Completed
• Trial end date: 2019-01-20
• Target enrollment: 0
• Participant gender: All

Summary

The prognosis of exudative age-related macular degeneration (AMD) accompanied by submacular hemorrhage is generally poor. A recently developed anti-VEGF agent eyeliaTM is also a useful treatment option for exudative AMD. However, one major limitation of VIEW study was that lack of data regarding eyes with submacular hemorrhage. The purpose of the present study was to evaluate the efficacy of Eylea in submacular hemorrhage secondary to exudative AMD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kim's Eye Hospital
• Collaborator: Bayer
• Treatments: Aflibercept; Endothelial Growth Factors; Mitogens

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