title: PERSISTENT RETINAL CHANGES AFTER INTRAVITREAL OCRIPLASMIN.
abstract: OBJECTIVE
  Postmarket analysis helps identify potentially important side effects not discovered during clinical trials. Ocriplasmin is a recently approved medication administered by intravitreal injection for the treatment of symptomatic vitreomacular adhesion and macular hole. Overall, clinical trials of ocriplasmin have shown a relatively high safety profile. However, recently, a series of case reports have highlighted acute vision loss associated with abnormal findings on spectral domain optical coherence tomography and electroretinography.
  
  
  RESULTS
  A 70-year-old man developed multiple discrete pockets of macular subretinal fluid 10 weeks after intravitreal ocriplasmin injection, with minimal resolution of fluid over 11 months. Electroretinographic findings demonstrated persistent rod photoreceptor sensitivity loss at 14 months after injection.
  
  
  CONCLUSIONS
  This is the first report of persistent electroretinographic and optical coherence tomographic abnormalities after ocriplasmin injection. Electroretinography abnormalities were noted in a small percentage of patients during ocriplasmin clinical trials and in a recent series of case reports and postmarket survey analysis. The authors propose that cleavage of fibronectin and laminin causes disruption of the interphotoreceptor matrix, leading to the ellipsoid layer attenuation and resultant electroretinographic sensitivity loss and subretinal fluid described on spectral domain optical coherence tomography. Persistent changes over 14 months in this patient indicate that ocriplasmin may have the potential to cause permanent retinal damage.
authors.affiliation: Department of Ophthalmology and Visual Sciences, University of Maryland, Baltimore, Maryland.
authors.forename: Jordan A
authors.initials: JA
authors.lastname: Margo
authors.forename: Lisa S
authors.initials: LS
authors.lastname: Schocket
authors.forename: Karen
authors.initials: K
authors.lastname: Klima
authors.forename: Mary A
authors.initials: MA
authors.lastname: Johnson
mesh_terms: D000368:Aged; D005341:Fibrinolysin / Q000009:adverse effects*; D005343:Fibrinolytic Agents / Q000009:adverse effects*; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D010446:Peptide Fragments / Q000009:adverse effects*; D020419:Photoreceptor Cells, Vertebrate / Q000502:physiology; D012164:Retinal Diseases / Q000139:chemically induced*; D012167:Retinal Perforations / Q000188:drug therapy*; D058471:Subretinal Fluid / Q000378:metabolism
chemical_list: D005343:Fibrinolytic Agents; D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin