Clinical trial NCT03396861: Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept
Official title: Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Irvine-Gass Syndrome
Keywords: macular edema
pseudophakia
pseudophakic macular edema
retinal swelling
aflibercept
anti-vascular endothelial growth factor
subconjunctival injection
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2018-01-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Adverse Events
timeFrame: Month 2
Secondary outcomes:
measure: Change in visual acuity
timeFrame: Month 2 and Month 6
measure: Change in central retinal thickness
timeFrame: Month 2 and Month 6
measure: Proportion of patients needing re-treatment
timeFrame: Month 1
measure: Proportion of patients needing additional non-study treatment though Month 6
timeFrame: Month 6
measure: Adverse Events - end of study period
timeFrame: Month 6
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Elias Reichel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muakkassa NW, Klein KA, Hamrah P, Reichel E. Subconjunctival Bevacizumab for the Treatment of Keratoprosthesis-Associated Cystoid Macular Edema. Ophthalmic Surg Lasers Imaging Retina. 2016 Mar;47(3):276-9. doi: 10.3928/23258160-20160229-11.
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citation: Kitchens JW, Do DV, Boyer DS, Thompson D, Gibson A, Saroj N, Vitti R, Berliner AJ, Kaiser PK. Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. Ophthalmology. 2016 Jul;123(7):1511-20. doi: 10.1016/j.ophtha.2016.02.046. Epub 2016 Apr 12.