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Abstract #20042 Published in IGR 9-4
Factors affecting the outcome of trabeculectomy: an analysis based on combined data from two phase III studies of an antibody to transforming growth factor β2, CAT-152
CAT-152 Trabeculectomy Study Group; Grehn F; Holló G; Khaw P; Overton B; au; Wilson R; Vogel R; Smith ZOphthalmology 2007; 114: 1831-1838
PURPOSE: To determine the factors affecting trabeculectomy success. DESIGN: Retrospective analysis of two randomized controlled trials comparing an antibody against transforming growth factor β2 (TGF-β2) with vehicle (placebo) for prevention of fibrosis after trabeculectomy, in which there was no significant difference between the treatment groups. PARTICIPANTS: Data were from patients (n = 726) with a diagnosis of primary open-angle glaucoma, chronic angle-closure glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma (PG) who had an intraocular pressure (IOP) > 21 mmHg and visual field or optic disc changes characteristic of glaucoma and were taking the maximum tolerated dose of medication before trabeculectomy. METHODS: Patients had trabeculectomy and 4 subconjunctival injections of a human monoclonal antibody to TGF-β2 (CAT-152) or a placebo. The definition of trabeculectomy success in the protocols was an IOP between six and 16 mmHg inclusive at months six and 12. Analyses of success used factors identified by ophthalmic experts. MAIN OUTCOMES MEASURES: Covariates analyzed included patient age, black race, gender, time since diagnosis, primary diagnosis, country, diabetes, mean defect, cup-to-disc (C/D) ratio, suture type, anesthetic, flap type, IOP at listing for surgery, suture release/lysis, needling, reformed anterior chamber, wound leak, severe bleb vascularity, and bleb microcysts. RESULTS: A stepwise logistic regression model found the following predictors of treatment success: PG (odds ratio [OR], 4.11; 95% confidence interval [CI], 1.41-11.99), high C/D ratio (OR, 2.84; 95% CI, 1.15-6.99), and use of a corneal traction suture (OR, 1.67; 95% CI, 1.09-2.56). A negative relationship was found for black race (OR, 0.28; 95% CI, 0.13-0.62); treatment in France (OR, 0.35; 95% CI, 0.17-0.70), Sweden (OR, 0.17; 95% CI, 0.05-0.58), Spain (OR, 0.37; 95% CI, 0.21-0.68), Poland (OR, 0.53; 95% CI, 0.32-0.88), or Hungary (OR, 0.14; 95% CI, 0.06-0.34); and suture release/lysis (OR, 0.34; 95% CI, 0.22-0.53). The effect of needling was marginally statistically significant (OR, 0.56; 95% CI, 0.31-1.01). CONCLUSIONS: Successful trabeculectomy outcome was associated with PG, higher C/D ratio, and corneal traction suturing. Factors associated with surgical failure were black race and suture release/lysis. Intercountry differences also were observed.
CAT-152 Trabeculectomy Study Group, University Eye Hospital, Würzburg, Germany
Classification:
12.8.10 Woundhealing antifibrosis (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
11.14 Investigational drugs; pharmacological experiments (Part of: 11 Medical treatment)