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-beta2) 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 microg recombinant TGF-beta2 or placebo to the macular hole after fluid-gas exchange.

INTERVENTION

The effect of recombinant TGF-beta2 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-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.