title: Safety of intravitreal ocriplasmin for focal vitreomacular adhesion in patients with exudative age-related macular degeneration.
abstract: OBJECTIVE
  The evaluation of the safety and preliminary efficacy of 125 μg ocriplasmin intravitreal injection in patients with focal vitreomacular adhesion (VMA) and exudative age-related macular degeneration (AMD).
  
  
  METHODS
  Randomized, sham-injection controlled, double-masked, multicenter, phase II trial.
  
  
  METHODS
  A total of 100 patients with VMA and wet AMD were randomized 3:1 to receive 125 μg ocriplasmin intravitreal injection or sham injection.
  
  
  METHODS
  Study treatment was administered in the mid-vitreous cavity by injection. Post-treatment safety and efficacy assessments were made at baseline and on days 7, 14, and 28 and months 3, 6, and 12 after injection. Secondary efficacy end points were exploratory in nature.
  
  
  METHODS
  The safety and tolerability of ocriplasmin were evaluated. The primary efficacy end point was the proportion of patients with VMA release at day 28 after injection. Secondary end points reported included VMA release over time, total posterior vitreous detachment (PVD), change in visual acuity from baseline, and number of anti-vascular endothelial growth factor (VEGF) injections.
  
  
  RESULTS
  The safety of ocriplasmin in patients with VMA and wet AMD was shown to be comparable to the known safety profile, with the majority of adverse events in the study eye occurring in the first 7 days after study treatment. A greater proportion of patients achieved VMA resolution and total PVD at month 12 with ocriplasmin compared with sham treatment. There was a decrease in the number of anti-VEGF injections with ocriplasmin at month 12 compared with the sham group, although no differences in visual acuity were observed.
  
  
  CONCLUSIONS
  Ocriplasmin treatment in this population seems to be generally safe and well tolerated and resulted in more patients achieving VMA resolution and PVD with less anti-VEGF use compared with sham treatment.
authors.affiliation: Retina Vitreous Associates, Los Angeles, California. Electronic address: rognov@laretina.com.
authors.forename: Roger L
authors.initials: RL
authors.lastname: Novack
authors.affiliation: Department of Biomedical and Clinical Science, Luigi Sacco Hospital, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Staurenghi
authors.affiliation: NightstaRx Ltd, London, United Kingdom (formerly of ThromboGenics NV).
authors.forename: Aniz
authors.initials: A
authors.lastname: Girach
authors.affiliation: Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, United Kingdom.
authors.forename: Nirodhini
authors.initials: N
authors.lastname: Narendran
authors.affiliation: Center for Retina and Macular Disease, Winter Haven, Florida.
authors.forename: Michael
authors.initials: M
authors.lastname: Tolentino
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005122:Exudates and Transudates; D005260:Female; D005341:Fibrinolysin / Q000009:adverse effects / Q000627:therapeutic use*; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D012164:Retinal Diseases / Q000188:drug therapy* / Q000503:physiopathology; D000267:Tissue Adhesions / Q000188:drug therapy; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body / Q000187:drug effects; D020255:Vitreous Detachment / Q000188:drug therapy* / Q000503:physiopathology; D057135:Wet Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D005343:Fibrinolytic Agents; D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin