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

Ophthalmology
J T ThompsonG W Abrams

Abstract

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. The design was a prospective, multicenter, randomized, double-masked, placebo-controlled clinical study. 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. The effect of recombinant TGF-beta2 as an adjunctive agent for macular hole surgery was evaluated. Closure of the macular hole and change in visual acuity at 3 months were measured. 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). Intrao...Continue Reading

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