Randomized, controlled trial of a sustained delivery formulation of 5-fluorouracil for the treatment of failing blebs.

Abstract

PURPOSE:

To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling.

DESIGN:

Prospective, randomized, controlled trial.

PARTICIPANTS:

Fifty patients with previous trabeculectomy and scheduled by the managing physician for a needling intervention.

METHODS:

One eye of each patient was randomized to receive needling with HA-5FU mixture or needling with subconjunctival injection of 5FU solution alone.

MAIN OUTCOME MEASURES:

The primary outcome was the percentage of subjects with an intraocular pressure (IOP) <15 mmHg without any medications at 3 months. Secondary outcomes included the need for additional needling procedures and changes in bleb morphology.

RESULTS:

Forty-nine subjects (25 in the HA-5FU group and 24 in the 5FU group) completed 3 months of follow-up. At baseline, there was no significant difference between the groups in terms of demographic features, subtype of glaucoma, vertical cup-to-disc ratio, or visual field indices. The mean number of glaucoma medications at baseline was higher in the 5FU group (0.8±1.1 [mean ± standard deviation] vs. 0.2±0.6, P = 0.04). An IOP <15 mmHg without medications was reached in 48.0% of subjects in the HA-5FU group and in 33.3% of subjects in the 5FU group (P = 0.2). At 3 months, both groups demonstrated a significant decrease in IOP from baseline (HA-5FU: decrease of 5.9 mmHg [95% confidence interval, 3.4-8.4]; 5FU: decrease of 6.0 mmHg [95% confidence interval, 3.2-8.2]; P<0.001 for both). Intergroup comparisons for IOP change from baseline was not significant (P = 0.9). However, repeat needling was required more frequently in the 5FU group compared with the HA-5FU group (50.0% vs. 12.0%; P = 0.004). There were no significant differences in the number of reported adverse events, bleb vascularity, or morphology between the 2 groups.

CONCLUSIONS:

Subconjunctival injection of HA-5FU to revive bleb function after bleb needling is as effective as 5FU solution. Fewer repeat needlings were required after treatment with HA-5FU, suggesting that the use of a combined formulation of HA-5FU may improve the overall outcomes of bleb needlings.

• Authors: Arun Kumar Narayanaswamy, Kelvin Lee, Ma Zhen, Jocelyn Chua, Shu Ming Chai, Pui Yi Boey, Ce Zheng, Tin Aung, Subramanian Venkatraman, Tina Tzee Ling Wong
• Journal: Ophthalmology (Ophthalmology) Vol. 119 Issue 2 Pg. 314-20 (Feb 2012) ISSN: 1549-4713 [Electronic] United States
• PMID: 22153707 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Delayed-Action Preparations
• Hyaluronic Acid
• Fluorouracil

Topics

• Aged
• Aqueous Humor (metabolism)
• Conjunctiva (drug effects)
• Delayed-Action Preparations
• Female
• Fluorouracil (administration & dosage)
• Glaucoma (physiopathology, surgery)
• Humans
• Hyaluronic Acid (administration & dosage)
• Intraocular Pressure (physiology)
• Male
• Needles
• Ostomy (methods)
• Prospective Studies
• Tomography, Optical Coherence
• Tonometry, Ocular
• Trabeculectomy
• Treatment Failure