Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tufts Medical Center
With
Regeneron Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Diagnosed with pseudophakic CME defined as central retinal thickness (CRT)\>300 microns, presence of intraretinal cysts on optical coherence tomography (OCT) and visual acuity \<=20/32 with petaloid leakage on fluorescein angiogram and late leakage at the disc
2. Diagnosed with "recalcitrant" CME, defined as less than a 15% decrease in CRT after at least 6 weeks of topical non-steroidal anti-inflammatory drug
3. Has had cataract surgery in the study eye with posterior chamber or anterior chamber intraocular lens implantation
4. Willing and able to comply with clinic visits and study-related procedures
2. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
3. Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
4. Prior treatment with sub-Tenon's or intravitreal steroids.
5. Prior treatment with an intravitreal anti-vascular endothelial growth factor (VEGF) agent in the study eye or systemic administration of anti-VEGF.
6. Use of topical prostaglandin analogues or pilocarpine.
7. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with glaucoma medications.
8. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye.
9. Vision loss in the study eye, determined by the investigator to be from a cause other than CME, e.g. optic neuropathy, end-stage glaucoma.
10. Any significant media opacity including vitreous hemorrhage or corneal scarring.
11. Fluorescein dye allergy or intolerance
12. Allergy to aflibercept or any of the components
13. Cerebrovascular accident or myocardial infarction within 1 year of the screening visit.
14. Pregnant or breast-feeding women
15. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception starting at least 2 menstrual cycles prior to the baseline visit, during the study and in the 3 months immediately following the last dose of study drug.
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