Russo Andrea, Scaroni Nicolò, Gambicorti Elena, Turano Raffaele, Morescalchi Francesco, Costagliola Ciro, Semeraro Francesco
Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Brescia.
Eye Clinic, Department of Health Sciences, University of Molise, Campobasso, Italy.
Clin Ophthalmol. 2018 Mar 27;12:587-591. doi: 10.2147/OPTH.S159672. eCollection 2018.
The aim of this study was to evaluate whether indomethacin eye drops and intravitreal ranibizumab (IVR) injections would provide additional benefit over ranibizumab alone in the treatment of choroidal neovascularization (CNV).
This was a randomized, prospective pilot study of eyes with new-onset CNV. Fifty-eight patients were randomized 1:1 into a ranibizumab monotherapy (RM) group and a ranibizumab plus indomethacin (RI) group. All patients received monthly 0.5 mg IVR injections for 3 months, followed by monthly injections administered as needed. RI group patients also self-administered one drop of 0.5% indomethacin three times a day for 12 months. All patients were followed up for 12 months.
At 12 months, both groups showed significant improvement in best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The mean BCVA change from baseline to 12 months was -0.12±0.04 LogMAR and -0.20±0.04 LogMAR in the RM and RI groups, respectively, with the degree of change being significantly different between the two groups (=0.04). At 12 months, the mean CRT in the RM group (316±41.2 µm) was significantly higher than that in the RI group (287±31.5 µm; =0.004). The mean required number of IVR injections was 7.38±0.78 and 6.34±0.67 in the RM and RI groups, respectively (<0.001).
Compared to IVR monotherapy, combination therapy with indomethacin eye drops and IVR provides superior anatomical and visual outcomes in patients with naive CNV lesions. Moreover, topical indomethacin might reduce the frequency of IVR injections, which is very beneficial considering the chronic and expensive nature of IVR therapy.
本研究旨在评估吲哚美辛滴眼液联合玻璃体内注射雷珠单抗（IVR）治疗脉络膜新生血管（CNV）是否比单纯使用雷珠单抗具有更多益处。
这是一项针对新发CNV患者的随机、前瞻性试点研究。58例患者按1:1随机分为雷珠单抗单药治疗（RM）组和雷珠单抗联合吲哚美辛（RI）组。所有患者每月接受0.5mg IVR注射，共3个月，之后根据需要每月注射。RI组患者还每天自行滴眼0.5%吲哚美辛一滴，持续12个月。所有患者随访12个月。
12个月时，两组的最佳矫正视力（BCVA）和中心视网膜厚度（CRT）均有显著改善。RM组和RI组从基线到12个月的平均BCVA变化分别为-0.12±0.04 LogMAR和-0.20±0.04 LogMAR，两组间变化程度有显著差异（P=0.04）。12个月时，RM组的平均CRT（316±41.2µm）显著高于RI组（287±31.5µm；P=0.004）。RM组和RI组所需IVR注射的平均次数分别为7.38±0.78和6.34±0.67（P<0.001）。
与IVR单药治疗相比，吲哚美辛滴眼液联合IVR的联合治疗在初发CNV病变患者中提供了更好的解剖学和视觉效果。此外，局部使用吲哚美辛可能会减少IVR注射的频率，考虑到IVR治疗的长期性和昂贵性，这非常有益。
