Status:
TERMINATED
Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Irvine-Gass Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research study is being conducted to determine the safety and tolerability of subconjunctival injections of aflibercept in the treatment of pseudophakic cystoid macular edema that has not respond...
Eligibility Criteria
Inclusion
- 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
- 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
- Has had cataract surgery in the study eye with posterior chamber or anterior chamber intraocular lens implantation
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Exclusion
- Retinal diseases (including diabetic retinopathy, retinal vein or artery occlusion, neovascular age-related macular degeneration, radiation retinopathy, vitreomacular traction, epiretinal membrane).
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
- Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
- Prior treatment with sub-Tenon's or intravitreal steroids.
- Prior treatment with an intravitreal anti-vascular endothelial growth factor (VEGF) agent in the study eye or systemic administration of anti-VEGF.
- Use of topical prostaglandin analogues or pilocarpine.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with glaucoma medications.
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye.
- 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.
- Any significant media opacity including vitreous hemorrhage or corneal scarring.
- Fluorescein dye allergy or intolerance
- Allergy to aflibercept or any of the components
- Cerebrovascular accident or myocardial infarction within 1 year of the screening visit.
- Pregnant or breast-feeding women
- 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.
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03396861
Start Date
February 22 2019
End Date
January 2 2020
Last Update
October 15 2024
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111