A randomized phase II trial of interferon-alpha2b versus 5-fluorouracil after trabeculectomy.

摘要: Purpose: The aim of the present study was to investigate safety and potential efficacy subconjunctival interferon-α2b (IFN-α), either alone or in combination with 5-fluorouracil (5-FU), reducing risk failure glaucoma surgery. Methods: A prospective, masked randomized phase II undertaken which patients received three injections per week for 3–4 weeks postoperatively. Three treatments were compared: (i) IFN-α (1 × 106 IU dose); (ii) 5-FU (5 mg (iii) alternating (BOTH). primary outcome measures were: rate successful control intra-ocular pressure without further surgery; incidence side effects. Results: Fifty-seven undergoing surgery an increased evaluated, including 23 (40%) trabeculectomy combined extracapsular cataract extraction as well other conventional high-risk groups. With 53 (93%) completing 2 years follow up, there no significant difference success rates among Intra-ocular controlled 79% (95% confidence interval (CI): 61, 97%) receiving IFN-α, 89% (76, 100%) BOTH. Side effects similar groups. Conclusions: These results are consistent a beneficial effect IFN-α2b given after filtering surgery. However, lack clear substantial benefit over anti-fibrotic therapy does not support clinical evaluation these treatments.