title: EVALUATION OF FULL-FIELD ELECTRORETINOGRAM REDUCTIONS AFTER OCRIPLASMIN TREATMENT: Results of the OASIS Trial ERG Substudy.
abstract: OBJECTIVE
  To explore a possible association between full-field electroretinograms with vitreomacular adhesion resolution and best-corrected visual acuity as part of the prospective, randomized, double-masked, sham-controlled Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial studying ocriplasmin.
  
  
  METHODS
  The ERG substudy enrolled 62 of 220 OASIS subjects (randomized 2:1) and analyzed full-field electroretinograms and their association with both vitreomacular adhesion resolution and best-corrected visual acuity from baseline through Month 24. Electroretinogram reductions were defined as acute full-field electroretinogram reductions in amplitude of ≥40% from baseline occurring at postinjection Day 7 or Day 28.
  
  
  RESULTS
  In the ocriplasmin group, 16/40 (40%) subjects developed ERG reductions, compared to 1/21 (4.8%) in the sham group; 13/16 (81.3%) and 1/1 (100%) resolved by study end, respectively. A total of 11/16 (68.8%) ocriplasmin-treated subjects with ERG reductions achieved vitreomacular adhesion resolution, compared to those without (9/24, 37.5%). The ocriplasmin-treated subjects with ERG reductions also gained more letters on average (11.3 vs. 9.3 letters) from baseline and had a difference of 6.7 letters in mean best-corrected visual acuity by study end compared to those without ERG reductions.
  
  
  CONCLUSIONS
  Ocriplasmin-treated subjects with ERG reductions had a higher rate of vitreomacular adhesion resolution and showed better visual improvement than their counterparts without ERG reductions or sham subjects by study end.
authors.affiliation: Retina Foundation of the Southwest, Dallas, Texas.
authors.forename: David G
authors.initials: DG
authors.lastname: Birch
authors.affiliation: Retina Consultants Houston, Houston, Texas.
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Benz
authors.affiliation: Cincinnati Eye Institute, Cincinnati, Ohio.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Miller
authors.affiliation: Charlotte Eye Ear Nose & Throat Associates, P.A., Charlotte, North Carolina.
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Antoszyk
authors.affiliation: Thomas Jefferson Medical College & Wills Eye Hospital, Philadelphia, Pennsylvania.
authors.forename: Joseph
authors.initials: J
authors.lastname: Markoff
authors.affiliation: ThromboGenics, NV, Leuven, Belgium.
authors.forename: Petra
authors.initials: P
authors.lastname: Kozma
authors.affiliation: ThromboGenics, NV, Leuven, Belgium.
authors.forename: Esmeralda
authors.initials: E
authors.lastname: Meunier
authors.affiliation: Thomas Jefferson Medical College & Wills Eye Hospital, Philadelphia, Pennsylvania.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Sergott
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004596:Electroretinography / Q000187:drug effects*; D005260:Female; D005341:Fibrinolysin / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D008266:Macula Lutea / Q000473:pathology* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage*; D011446:Prospective Studies; D012167:Retinal Perforations / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D000267:Tissue Adhesions / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D016896:Treatment Outcome; D014792:Visual Acuity; D014822:Vitreous Body / Q000473:pathology* / Q000503:physiopathology; D020255:Vitreous Detachment / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin