Treatment of Macular Edema After Cataract Surgery With Subconjunctival Aflibercept
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | January 2019 |
| End Date: | September 2020 |
| Contact: | Elias Reichel, MD |
| Email: | ereichel@tuftsmedicalcenter.org |
| Phone: | 617-636-1648 |
Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema
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.
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.
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.
We found this trial at
1
site
800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Elias Reichel, MD
Phone: 617-636-5489
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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