Transforming growth factor-β2 significantly enhances the ability to flatten the rim of subretinal fluid surrounding macular holes: Preliminary anatomic results of a multicenter prospective randomized study

Previous studies of treatment of full-thickness macular holes have effected resolution of the surrounding subretinal fluid cuff in 58%-71% of cases. An initial report has found 330 ng and 1,330 ng transforming growth factor-β2 to be successful in effecting resolution of the surrounding subretinal fluid cuff in 100% of cases. A randomized, masked, controlled, prospective, multicenter study of 90 patients with full-thickness macular holes was performed to assess the efficacy of the local application of TGF- β₂ at the time of vitrectomy surgery. Eligibility criteria included: (1) best corrected visual acuity of 20/80 or worse; (2) duration of macular hole for less than 1 year; and (3) absence of other ocular disorders that might interfere with vision. Patients were evenly randomized to receive placebo, 660 ng transforming growth factor-β₂, or 1,330 ng transforming growth factor-β₂. The treatment assignment was unmasked at the examination 3 months after treatment only if the macular hole failed to close. If the initial treatment had been placebo, patients were offered crossover to 1,330 ng transforming growth factor-β₂ during a reoperation. It can be deduced that resolution of the subretinal fluid cuff occurred in 16 of 30 placebo- treated eyes, 53 of 58 eyes treated with transforming growth factor-β₂, and in 9 of 13 cases (69%) initially treated with placebo that subsequently underwent repeat surgery under the crossover option. This preliminary report demonstrates that a single application of transforming growth factor-β₂ has a statistically significant beneficial effect on resolution of the subretinal fluid cuff surrounding a macular hole when used in conjunction with standard vitrectomy for full-thickness macular holes.