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:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT03396861
Eligibility Criteria:
Inclusion Criteria:
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
5. Provide signed informed consent
Exclusion Criteria:
1. Retinal diseases (including diabetic retinopathy, retinal vein or artery occlusion, neovascular age-related macular degeneration, radiation retinopathy, vitreomacular traction, epiretinal membrane).
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03396861
Study Brief:
Protocol Section:
NCT03396861