Irvine-Gass Syndrome
Conditions
Keywords
macular edema, pseudophakia, pseudophakic macular edema, retinal swelling, aflibercept, anti-vascular endothelial growth factor, subconjunctival injection
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.
Interventions
DRUGAflibercept
Subconjunctival aflibercept
Sponsors
Regeneron Pharmaceuticals
Tufts Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Month 2 | Systemic and ocular adverse events of subconjunctivally administered aflibercept injection in the treatment of pseudophakic cystoid macular edema at Month 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual acuity | Month 2 and Month 6 | Change in best-corrected visual acuity at Months 2 and 6 |
| Change in central retinal thickness | Month 2 and Month 6 | Change in central retinal thickness as measured by optical coherence tomography at Months 2 and 6 |
| Proportion of patients needing re-treatment | Month 1 | Proportion of patients needing subconjunctival aflibercept injection treatment at Month 1 |
| Proportion of patients needing additional non-study treatment though Month 6 | Month 6 | Proportion of patients receiving additional non-study treatment (e.g. periocular or intravitreal steroid) through Month 6 |
| Adverse Events - end of study period | Month 6 | Incidence and severity of systemic and ocular events at Month 6 |
Countries
United States
Outcome results
None listed