Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Men or women great than or equal to 50 years of age with unilateral neovascular AMD
2. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
3. Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye
4. The CNV area must be at least 50% of total lesion size
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide signed informed consent
7. Provide signed Health Insurance Portability and Accountability Act (HIPAA) authorization
You may not be if
1. Neovascular AMD in the fellow eye
2. Corneal endothelial measures as judged by an independent reading center
3. Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
4. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema
5. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening
6. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of screening
7. Contact lens wear in either eye within 6 months of screening
8. History of angle closure glaucoma in either eye
9. Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG, prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or YAG Capsulotomy within 3 months of screening
10. History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye
11. Any prior ocular trauma (blunt or penetrating) in either eye
12. Embedded corneal foreign body in either eye
13. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
14. Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
15. Any prior ocular inflammation/infection in either eye within 3 months of the screening visit
16. Any prior use of amantadine
17. Significant pre-retinal fibrosis involving the macula in the study eye (where, in the opinion of the investigator, the pre-retinal fibrosis is causing distortion or traction on the central macular region which may be limiting vision, or inducing retinal edema/thickening, beyond that due to underlying CNV)
18. Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at screening
20. Current treatment with systemic anti-VEGF therapeutics at screening
21. Known serious allergy to the fluorescein sodium for injection in angiography
22. Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
23. Positive serum hCG pregnancy test at the screening visit
Clareo Health | Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
