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Bevacizumab in High-Risk Corneal Transplantation

2022; Elsevier BV; Volume: 129; Issue: 8 Linguagem: Inglês

10.1016/j.ophtha.2022.03.024

1549-4713

Thomas H. Dohlman, Matthew J. McSoley, Francisco Amparo, Tatiana Carreno-Galeano, Mengyu Wang, Mohammad H. Dastjerdi, Rohan Bir Singh, Giulia Coco, Antonio Di Zazzo, Hasanain Shikari, Ujwala S. Saboo, Kimberly C. Sippel, Jessica Ciralsky, Sonia H. Yoo, Matheus Sticca, Tais Hitomi Wakamatsu, Somasheila Murthy, Pedram Hamrah, Ula V. Jurkunas, Joseph B. Ciolino, José Álvaro Pereira Gomes, Victor L. Perez, Jia Yin, Reza Dana,

Ocular Surface and Contact Lens

To determine the efficacy of local (subconjunctival and topical) bevacizumab (Avastin) treatment in patients undergoing vascularized high-risk corneal transplantation.Pilot, prospective, randomized, double-blind, placebo-controlled clinical trial conducted at 5 clinical centers in the United States, India, and Brazil.Patients aged > 18 years undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft.Patients were randomized to receive subconjunctival bevacizumab (2.5 mg/0.1 ml) or placebo at the time of surgery, followed by topical bevacizumab (10 mg/ml) or topical placebo, administered 4 times per day for 4 weeks.The 52-week endothelial immune rejection rate.Ninety-two patients were randomized to receive bevacizumab (n = 48) or control (n = 44). The 52-week endothelial rejection rate was 10% in the bevacizumab group and 19% in the control group (P = 0.20). Post hoc, extended follow-up at the lead study site showed an endothelial rejection rate of 3% in the bevacizumab group and 38% in the control group (P = 0.003). Treatment with bevacizumab was found to have a hazard ratio of 0.15 (95% confidence interval, 0.03-0.65, P = 0.01) in a post hoc Cox regression analysis.In patients undergoing vascularized high-risk corneal transplantation, there was no statistically significant difference in the rate of endothelial rejection at 1 year in the bevacizumab treatment group compared with the control group. This study may have been underpowered to detect a difference between treatment groups, and taken together, our data suggest that, in the current trial design, bevacizumab has a positive but not (yet) significant effect on endothelial rejection.