title: intravitreal tumor necrosis factor inhibitors in the treatment of refractory diabetic macular edema: a pilot study from the Pan-American Collaborative Retina Study Group.
abstract: OBJECTIVE
  The purpose of this study was to report the short-term visual and anatomical outcomes after intravitreal injections of two different tumor necrosis factor α inhibitors in eyes with refractory diabetic macular edema.
  
  
  METHODS
  An interventional, retrospective, multicenter study of 39 eyes with refractory diabetic macular edema that were injected with adalimumab (n = 5 for 2 mg) or infliximab (n = 15 for 1 mg; n = 19 for 2 mg). The main outcome measures were the best-corrected visual acuity and the central macular thickness at 3 months of follow-up.
  
  
  RESULTS
  In the 1-mg infliximab group, the logarithm of the minimal angle of resolution best-corrected visual acuity improved from 1.49 ± 0.58 at baseline to 1.38 ± 0.56 at 3 months (P = 0.6991). In the 2-mg infliximab group, the logarithm of the minimal angle of resolution best-corrected visual acuity worsened from 0.76 ± 0.54 to 1.03 ± 0.69 at 3 months (P = 0.5995). In the adalimumab group, the logarithm of the minimal angle of resolution best-corrected visual acuity improved from 1.44 ± 0.77 to 1.08 ± 0.85 at 3 months (P = 0.2500). The central macular thickness in the 1-mg infliximab group decreased from 459 ± 125 μm at baseline to 388 ± 131 μm at 3 months (P = 0.1178). In the 2-mg infliximab group, the central macular thickness remained unchanged from 378 ± 97 μm at baseline to 349 ± 118 μm at 3 months (P = 0.2162). In the adalimumab group, the central macular thickness remained unchanged from 521 ± 163 μm at baseline to 526 ± 390 μm at 3 months (P = 0.1250). There were no systemic side effects reported in any of the patients. However, laboratory markers for autoimmunity were not done. None of the eyes injected with either adalimumab or 1 mg of infliximab had adverse ocular events. In the 2-mg infliximab group, 42% (8 of 19) of eyes developed severe uveitis. Three of these eyes (37.5%) required pars plana vitrectomy. The uveitis in the remaining five eyes resolved with topical steroid therapy.
  
  
  CONCLUSIONS
  Both intravitreal adalimumab and infliximab do not appear to benefit eyes with refractory diabetic macular edema. Intravitreal injections of infliximab may elicit a severe intraocular inflammatory reaction.
authors.affiliation: Instituto de Cirugia Ocular, San José, Costa Rica. LW65@cornell.edu
authors.forename: Lihteh
authors.initials: L
authors.lastname: Wu
authors.forename: Erick
authors.initials: E
authors.lastname: Hernandez-Bogantes
authors.forename: José A
authors.initials: JA
authors.lastname: Roca
authors.forename: J Fernando
authors.initials: JF
authors.lastname: Arevalo
authors.forename: Karen
authors.initials: K
authors.lastname: Barraza
authors.forename: Andres F
authors.initials: AF
authors.lastname: Lasave
mesh_terms: D000068879:Adalimumab; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D058449:Intravitreal Injections; D008266:Macula Lutea / Q000473:pathology; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012189:Retrospective Studies; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab