ACME: Treatment of Macular Edema After Cataract Surgery With Subconjunctival Aflibercept

Sponsor

Tufts Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT03396861

Collaborator

Regeneron Pharmaceuticals (Industry)

Enrollment

Location

Arm

10.3

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irvine-Gass Syndrome	Drug: Aflibercept	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema

Actual Study Start Date :

Feb 22, 2019

Actual Primary Completion Date :

Aug 18, 2019

Actual Study Completion Date :

Jan 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subconjunctival aflibercept Subconjunctival aflibercept 2 milligrams (mg) /0.05 milliliters (mL) administered at baseline visit and possibly again at Month 1 visit depending on initial response.	Drug: Aflibercept Subconjunctival aflibercept

Arm

Intervention/Treatment

Experimental: Subconjunctival aflibercept

Subconjunctival aflibercept 2 milligrams (mg) /0.05 milliliters (mL) administered at baseline visit and possibly again at Month 1 visit depending on initial response.

Drug: Aflibercept

Subconjunctival aflibercept

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Provide signed informed consent

Exclusion Criteria:

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.