Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept (NCT03396861) | Clinical Trial Compass
TerminatedPhase 1
Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept
Stopped: Low enrollment
United States1 participantsStarted 2019-02-22
Plain-language 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 responded well to first-line standard of care treatment (eye drops).
Pseudophakic cystoid macular edema (CME) is swelling of the retina that can occur weeks or years after cataract surgery and typically results in decreased vision. Subconjunctival injections are injections placed just beneath the clear membrane (conjunctiva) of the eye.
A recent report of one patient who received two subconjunctival injections of a similar medication to the one being studied here indicated that subconjunctival injections of this class of medication may be an effective and less invasive alternative to intravitreal injections for pseudophakic CME. Because of the similarity of the drugs and the patient's treatment success, we would like to see if subconjunctival injection(s) of aflibercept will work in treating pseudophakic CME. If successful, the risk of an intraocular infection and glaucoma that comes with standard of care treatments might be greatly reduced.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
. 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.