title: INTRAOCULAR PRESSURE IN PATIENTS WITH DIABETIC MACULAR EDEMA TREATED WITH DEXAMETHASONE INTRAVITREAL IMPLANT IN THE 3-YEAR MEAD STUDY.
abstract: OBJECTIVE
  To evaluate the occurrence, management, and clinical significance of increases in intraocular pressure (IOP) in patients with diabetic macular edema treated with dexamethasone intravitreal implant (DEX implant).
  
  
  METHODS
  Randomized, multicenter, 3-year, Phase III study. Patients (N = 1,048) with diabetic macular edema were randomized to DEX implant 0.7-mg, DEX implant 0.35-mg, or sham procedure with retreatment allowed at ≥6-month intervals (seven injections maximum).
  
  
  RESULTS
  In the DEX implant 0.7-mg, DEX implant 0.35-mg, and sham groups, respectively, ≥10-mmHg IOP increases from baseline occurred in 27.7%, 24.8%, and 3.7% of patients, and their frequency did not increase with repeat injections. IOP-lowering medication was used by 41.5%, 37.6%, and 9.1% of patients. Only one patient (0.3%) in each DEX implant group had filtering surgery to manage a steroid-induced IOP increase. Among DEX implant 0.7-mg-treated patients with and without a ≥10-mmHg IOP increase, 21.9% (21 of 96) and 22.4% (57 of 255), respectively, achieved ≥15-letter best-corrected visual acuity gain at the end of the study, and mean average change in central retinal thickness from baseline was -127 μm and -106 μm, respectively.
  
  
  CONCLUSIONS
  DEX implant demonstrated clear benefit of treatment despite increases in IOP. Sequential implants had no cumulative effect on IOP.
authors.affiliation: *Midwest Eye Institute, Indianapolis, Indiana; †Kaplan Medical Center, Rehovot, Israel; ‡Peregrine Eye and Laser Institute, Makati, Philippines; §Fondazione GB Bietti-IRCCS, Rome, Italy; ¶Ocular Surgery Center, University of São Paulo, São Paulo, Brazil; **Allergan plc, Irvine, California; ††Avanir Pharmaceuticals, Inc, Aliso Viejo, California; and ‡‡Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, California.
authors.forename: Raj K
authors.initials: RK
authors.lastname: Maturi
authors.forename: Ayala
authors.initials: A
authors.lastname: Pollack
authors.forename: Harvey S
authors.initials: HS
authors.lastname: Uy
authors.forename: Monica
authors.initials: M
authors.lastname: Varano
authors.forename: Andre M V
authors.initials: AM
authors.lastname: Gomes
authors.forename: Xiao-Yan
authors.initials: XY
authors.lastname: Li
authors.forename: Harry
authors.initials: H
authors.lastname: Cui
authors.forename: Jean
authors.initials: J
authors.lastname: Lou
authors.forename: Yehia
authors.initials: Y
authors.lastname: Hashad
authors.forename: Scott M
authors.initials: SM
authors.lastname: Whitcup
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects*; D003930:Diabetic Retinopathy / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004343:Drug Implants; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D058449:Intravitreal Injections; D008269:Macular Edema / Q000000981:diagnostic imaging / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging; D009798:Ocular Hypertension / Q000139:chemically induced* / Q000175:diagnosis / Q000188:drug therapy; D012008:Recurrence; D019233:Retreatment; D041623:Tomography, Optical Coherence; D014065:Tonometry, Ocular
chemical_list: D000959:Antihypertensive Agents; D004343:Drug Implants; D005938:Glucocorticoids; D003907:Dexamethasone