TRANSFORMING GROWTH-FACTOR-BETA-2 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 eff ected resolution of the surrounding subretinal fluid cuff in 58%-71% o f cases. An initial report has found 330 ng and 1,330 ng transforming growth factor-beta2 to be successful in effecting resolution of the su rrounding 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 lo cal application of TGF-beta2 at the time of vitrectomy surgery. Eligib ility criteria included: (1) best corrected visual acuity of 20/80 or worse; (2) duration of macular hole for less than 1 year; and (3) abse nce of other ocular disorders that might interfere with vision. Patien ts were evenly randomized to receive placebo, 660 ng transforming grow th factor-beta2, or 1,330 ng transforming growth factor-beta2. The tre atment assignment was unmasked at the examination 3 months after treat ment only if the macular hole failed to close. If the initial treatmen t had been placebo, patients were offered crossover to 1,330 ng transf orming growth factor-beta2 during a reoperation. It can be deduced tha t resolution of the subretinal fluid cuff occurred in 16 of 30 placebo -treated eyes, 53 of 58 eyes treated with transforming growth factor-b eta2, and in 9 of 13 cases (69%) initially treated with placebo that s ubsequently underwent repeat surgery under the crossover option. This preliminary report demonstrates that a single application of transform ing growth factor-beta2 has a statistically significant beneficial eff ect on resolution of the subretinal fluid cuff surrounding a macular h ole when used in conjunction with standard vitrectomy for full-thickne ss macular holes.