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The ACME Study

Title Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema: The ACME study
Therapeutic Area Cystoid Macular Edema
Principal Investigator Elias Reichel, MD
Min Age 18 Years
Gender All
Contact Michael Dixon
617 636-1051


This is a proof of concept study to determine the safety of subconjunctival aflibercept injection, an anti-vascular endothelial growth factor (VEGF) medication, in the treatment of recalcitrant pseudophakic cystoid macular edema (CME)

Study Details

Inclusion Criteria

  • Diagnosed with pseudophakis CME defined as:
    • Central retinal thickness (CRT) > 300 microns
    • Presence of intraretinal cysts on optical coherence tomography (OCT)
    • 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 implementation

Exclusion Criteria

  • Retinal diseases (including diabetic retinopathy, retinal vein or artery occlusion, neovascular age-related macular degeneration, radiation retinopathy)
  • Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
  • Active infect5ious conjunctivitis, keratitis, scleritis or endophtalmitis in either eye

Study Requirements

Participation will be approximately 6 months with 8 visits if criteria is met to continue with treatment at the monthly 1 visit. If subjects no allowed to continue with treatment they would complete 3 study visits.