Postoperative adjuvant subconjunctival ranibizumab in enhancing trabeculectomy efficacy

PURPOSE: To study the effect of post-trabeculectomy adjuvant ranibizumab injection into the bleb area on hypotensive surgical efficacy. METHODS: 90 patients (90 eyes) with primary open-angle glaucoma were randomized into 3 groups of 30 each: patients in group I were injected with 0.05 ml (0.5 mg) subconjunctival ranibizumab into the bleb area on day 2 after the surgery, group II - on day 7, whereas patients in the Control group received no postoperative injections. Tonometry was conducted on the following day after the surgery, as well as on weeks 1, 2 and 1, 3, 6 and 12 months after the injection in groups I and II and after the surgery -in the Control group. Bleb characteristics were assessed on corresponding timepoints according to the Wurzburg bleb classification score. Bleb hyperemia was measured by means of specially designed software “Hyperemia-3". Complex ophthalmological examination including visometry, perimetry, and retinal tomography was conducted before trabeculectomy and 6 and 12 months after. Endothelial cell count was taken prior to the operation, 1 week and 1 month after to assess possible toxic effect of ranibizumab. The rate of postoperative surgical and medical interventions (needling, hypotensive therapy), absolute and qualified success rate, IOP level as well as the ability to reach target IOP, individual IOP (tolerable IOP, tIOP) and tIOP buffer zone levels were used as surgery outcome measures. RESULTS: Mean IOP median a year after trabeculectomy reached 12.9+1.8, 12.4+2.6 and 13.9+2.0 mmHg in groups I, II and Control correspondingly. Postoperative needling was required in 23, 37 and 50% of patients in the same groups, further hypotensive therapy - in 17, 20 and 27%. Absolute success in groups I, II and Control was achieved correspondingly in 80, 73 and 70% for target pressure, 50, 40 and 23% for tolerable IOP and 83, 73 and 67% for tIOP buffer zone, which showed the efficacy of ranibizumab injections, especially on day 2 after the surgery. Qualified success during the same period (93, 87 and 83% for target pressure, 57, 47 and 23% for tolerable IOP and 100, 87 and 83% for tIOP buffer zone) revealed a similar tendency. Bleb characteristics dynamics according to WBCS confirmed positive effect of ranibizumab injection on the bleb morphofunctional state compared to the Control group. Hyperemia index analysis showed a significant bleb hyperemia decrease after adjuvant ranibizumab, starting from the first day after the injection and reaching as much as 20% in difference with the Control group. Insignificant changes in endothelial cell count showed the absence of subconjunctival ranibizumab toxic effect 1 week and 1 month after the injection. CONCLUSION: Subconjunctival ranibizumab injections (0.05 ml, 0.5 mg) into the bleb area help increase postoperative success rates, prolong hypotensive effect, enhance bleb morphological and functional characteristics and subdue postoperative hyperemia. Injections on day 2 were superior in efficacy and had a more pronounced hypotensive effect to those on day 7.

глаукома, трабекулэктомия, избыточное рубцевание, ингибиторы VEGF, ранибизумаб, glaucoma, trabeculectomy, wound healing, VEGF inhibitors

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