Randomized Controlled Trial Of A Sustained Delivery System Of 5-fluorouracil For The Treatment Of Failing Blebs

Abstract

Purpose: : To determine the efficacy of subconjunctival injection of hyaluronic acid (HA) -5Fluorouracil (5FU) formulation as an adjunct in reviving bleb function following needling.

Methods: : Fifty patients were enrolled in this prospective, randomized controlled trial. One eye of each patient documented to have a failed trabeculectomy and scheduled for a needling procedure was randomized to receive either needling with HA-5FU mixture or needling with subconjunctival injection of 5FU alone. The eyes were evaluated at 3 months for a comparative efficacy of procedures. The primary outcome was percentage of subjects with an intraocular pressure (IOP) below 15 mm Hg without any medications and secondary outcomes included the need for additional needling procedures and changes in bleb morphology.

Results: : Forty nine subjects (25 in HA-5FU and 24 in 5FU groups) completed 3 months follow-up. The mean number of glaucoma medications at baseline was higher in the 5-FU group (0.8 ± 1.1 [mean ± SD] versus 0.2 ± 0.6, p=0.04). An IOP below 15 mmHg without medications was reached in 48.0 % subjects in HA-5FU group and in 33.3 % subjects in 5FU group (p=0.2). At 3 months both the HA-5FU and the 5FU groups demonstrated significant decrease in IOP from baseline (HA-5FU - decrease of 5.9 mm Hg (95% Confidence Interval [CI]: 3.4 to 8.4 mm Hg; 5FU- decrease of 6.0 mm Hg (95% CI: 3.2 to 8.2; p<0.001 for both). Inter-group comparisons for IOP change from baseline was not significant (p=0.9) Repeat needling was required more frequently in the 5FU group compared to the HA-5FU group (50.0 % Vs 12.0 %; p= 0.004). There were no significant differences in bleb vascularity or morphology between the two groups.

Conclusions: : Adjunctive HA-5FU is as effective as 5FU solution in reviving bleb function. With lower frequency of repeat needlings, this formulation appears to be a safer alternative to 5FU.

Clinical Trial: : http://www.clinicaltrials.gov NCT00607685

Keywords: wound healing • conjunctiva