Comparison of recombinant transforming growth factor-beta-2 and placebo as an adjunctive agent for macular hole surgery

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-β₂) or placebo. Design: The design was a prospective, multicenter, randomized, double-masked, placebo-controlled clinical study. Participants: 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 μg recombinant TGF-β₂ or placebo to the macular hole after fluid-gas exchange. Intervention: The effect of recombinant TGF-β₂ as an adjunctive agent for macular hole surgery was evaluated. Main Outcome Measures: 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-β₂ (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-β₂ (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-β₂ (P = 0.42). Intraocular pressure elevation greater than 30 mmHg was more common 2 weeks after surgery in eyes treated with recombinant TGF-β₂ (P < 0.001). Conclusions: Recombinant TGF-β₂ 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-β₂ for the treatment of macular holes.