title: Comparison of recombinant transforming growth factor-beta-2 and placebo as an adjunctive agent for macular hole surgery.
abstract: OBJECTIVE
  This study aimed to compare the visual and anatomic results of macular hole surgery in eyes treated with recombinant transforming growth factor-beta-2 (TGF-beta2) or placebo.
  
  
  METHODS
  The design was a prospective, multicenter, randomized, double-masked, placebo-controlled clinical study.
  
  
  METHODS
  One hundred thirty eyes with idiopathic macular holes of 1 year or less and a refracted Early Treatment Diabetic Retinopathy Study visual acuity of 20/80 or worse were treated with 1.1 microg recombinant TGF-beta2 or placebo to the macular hole after fluid-gas exchange.
  
  
  METHODS
  The effect of recombinant TGF-beta2 as an adjunctive agent for macular hole surgery was evaluated.
  
  
  METHODS
  Closure of the macular hole and change in visual acuity at 3 months were measured.
  
  
  RESULTS
  The 3-month visits were completed for 120 eyes. The macular hole was closed at 3 months in 35 (61.4%) of 57 eyes treated with placebo and 49 (77.8%) of 63 eyes treated with recombinant TGF-beta2 (P = 0.08). The mean visual acuity gain was +6.4 letters in eyes receiving placebo and +8.9 letters in eyes treated with recombinant TGF-beta2 (P = 0.27). Visual acuity improved 2 or more lines in 23 (40.4%) of 57 eyes treated with placebo and 30 (47.6%) of 63 eyes treated with recombinant TGF-beta2 (P = 0.42). Intraocular pressure elevation greater than 30 mmHg was more common 2 weeks after surgery in eyes treated with recombinant TGF-beta2 (P < 0.001).
  
  
  CONCLUSIONS
  Recombinant TGF-beta2 resulted in a similar proportion of successful closure of macular holes as placebo. There was no statistically significant visual acuity benefit with the use of recombinant TGF-beta2 for the treatment of macular holes.
authors.affiliation: Retina Specialists, Baltimore, Maryland, USA.
authors.forename: J T
authors.initials: JT
authors.lastname: Thompson
authors.forename: W E
authors.initials: WE
authors.lastname: Smiddy
authors.forename: G A
authors.initials: GA
authors.lastname: Williams
authors.forename: R N
authors.initials: RN
authors.lastname: Sjaarda
authors.forename: H W
authors.initials: HW
authors.lastname: Flynn
authors.forename: R R
authors.initials: RR
authors.lastname: Margherio
authors.forename: G W
authors.initials: GW
authors.lastname: Abrams
mesh_terms: D000368:Aged; D017024:Chemotherapy, Adjuvant; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D011183:Postoperative Complications; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012167:Retinal Perforations / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery*; D016212:Transforming Growth Factor beta / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014821:Vitrectomy
chemical_list: D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta