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Abstract #5498 Published in IGR 1-2
A randomized phase II trial of interferon-alpha2b versus 5-fluorouracil after trabeculectomy
Gillies MC; Brooks AM; Young S; Gillies B; Simpson JM; Goldberg IAustralian and New Zealand Journal of Ophthalmology 1999; 27: 37-44
PURPOSE: The aim of the present study was to investigate the safety and potential efficacy of subconjunctival interferon-alpha2b (IFN-alpha), either alone or in combination with 5-fluorouracil (5-FU), in reducing the risk of failure of glaucoma surgery. METHODS: A prospective, masked randomized phase II study was undertaken in which patients received three subconjunctival injections per week for 3-4 weeks postoperatively. Three treatments were compared: (i) IFN-alpha (1 x 10 (6)IU per dose); (ii) 5-FU (5 mg per dose); and (iii) alternating IFN-alpha and 5-FU (BOTH). The primary outcome measures were: (i) rate of successful control of intra-ocular pressure without further surgery; and (ii) the incidence of side effects. RESULTS: Fifty-seven patients undergoing glaucoma surgery with an increased risk of failure were evaluated, including 23 patients (40%) undergoing trabeculectomy combined with extracapsular cataract extraction as well as other conventional high-risk groups.With 53 patients (93%) completing 2 years follow up,there was no significant difference in success rates among the three groups. Intra-ocular pressure was controlled without further surgery in 79% of patients (95% confidence interval (CI): 61, 97%) receiving IFN-alpha, in 89% of patients (76, 100%) receiving 5-FU and in 89% of patients (76, 100%) receiving both. Side effects were similar among the three groups. CONCLUSIONS: These results are consistent with a beneficial effect of IFN-alpha2b given either alone or in combination with 5-FU after glaucoma filtering surgery. However, the lack of a clear and substantial benefit over conventional anti-fibrotic therapy does not support the further clinical evaluation of these treatments.
Department of Ophthalmology, University of Sydney, New South Wales, Australia. mark@eye.usyd.edu.au
Classification:
12.8.10 Woundhealing antifibrosis (Part of: 12 Surgical treatment > 12.8 Filtering surgery)