Diyabetik maküla ödeminde 3 aylık yükleme dozu sonrasında aflibercept ve ranibizumabın anatomik cevap açısından karşılaştırılması

Öz

Amaç: Diyabetik maküla ödemi (DMÖ) tedavisinde aflibercept ve bevacizumabı kısa dönem anatomik ve fonksiyonel sonuçlar açısından karşılaştırmayı amaçladık. Yöntemler: Bu çalışma geriye dönük bir çalışmadır. Yeni tanı konmuş ve tedavi almamış DMÖ hastaları çalışmaya dahil edildi. Hastalara 3 ay boyunca yükleme dozu olarak intravitreal aflibercept (IVA) ya da intravitreal ranibizumab (IVR) uygulandı. Hastaların tedavi öncesi, 1.ay ve 3.aydaki en iyi düzeltilmiş görme keskinliği (EİDGK) ve merkezi maküla kalınlığı (MMK) değişimleri incelendi. Tedavi sonrasında hastalar erken anatomik cevabına göre 3.ayda iyi ya da kötü olarak sınıflandırıldı. Foveal kontürün oluştuğu ve maküla ödeminin tam olarak düzeldiği hastalar tedaviye iyi cevap veren sınıf olarak kabul edildi. Maküla ödeminin tam olarak geçmediği ve/veya foveal kontürün oluşmadığı hastalar tedaviye kötü cevap veren sınıf olarak kabul edildi. Daha sonra IVA ve IVR tedaviye cevap açısından birbirleriyle karşılaştırıldı. Bulgular: Çalışmaya 54 hastanın 67 gözü dahil edildi. Hastaların ortalama yaşı 62.7±7.3 (46-78) idi. 31 hasta kadın (%57,4) ve 23 hasta erkek (%42,6) idi. Gözlerin 33’üne (%49,3) IVA uygulanırken (IVA grubu) ve 34’üne (%50,7) IVR uygulandı (IVR grubu). IVA grubundaki hastaların tedavi öncesi, 1.ay ve 3.ay sonundaki ortalama EİDGK sırasıyla 0.75±0.39 LogMAR, 0.53±0.37 LogMAR (p<0.0001) ve 0.38±0.30 LogMAR (p<0.0001) idi. IVR grubundaki hastaların tedavi öncesi, 1.ay ve 3.ay sonundaki ortalama EİDGK sırasıyla 0.71±0.34 LogMAR, 0.52±0.34 LogMAR (p<0.0001) ve 0.39±0.30 LogMAR (p<0.0001) idi. IVA grubundaki hastaların tedavi öncesi, 1.ay ve 3.ay sonundaki ortalama MMK sırasıyla 400±82 mikrometre, 349±95 mikrometre (p<0.0001) ve 313±79 mikrometre (p<0.0001) idi. IVR grubundaki hastaların tedavi öncesi, 1.ay ve 3.ay sonundaki ortalama MMK sırasıyla 426±92 mikrometre, 365±74 mikrometre (p<0.0001) ve 323±60 mikrometre (p<0.0001) idi. IVA grubunda 24 göz (%72,7) ve IVR grubunda 18 göz (%52,9) tedaviye iyi cevap vermiştir (p=0,09). Sonuç: IVA ve IVR grubunun her ikisinde de 3 aylık yükleme dozu ile hem görsel hem de anatomik başarı sağlanabilmektedir. IVA grubunda tedaviye iyi cevap veren hasta oranı IVR grubuna göre daha yüksek bulunmasına rağmen istatistiksel olarak anlamlı bir farka rastlanmamıştır.

Anahtar Kelimeler

• Aflibercept
• Ranibizumab
• Diyabetik maküla ödemi

Comparison of the efficacy of aflibercept and ranibizumab after a 3-month loading dose in patients with diabetic macular edema

Abstract

Background/Aim: Diabetic macular edema (DME) is the main cause of visual loss in diabetic patients. Aflibercept and ranibizumab are among the most commonly used intravitreal agents in the DME. This study aims to compare the short-term anatomic and functional results of aflibercept and ranibizumab in the treatment of DME. Methods: This retrospective cohort study included newly diagnosed and treatment-naive DME patients. The patients were administered intravitreal aflibercept (IVA) or intravitreal ranibizumab (IVR) as a loading dose throughout 3 months. Pre-treatment and 1- and 3-month examinations were made of best corrected visual acuity (BCVA)and central macular thickness (CMT). After the treatment, the patients were classified in the 3rd month as those with good or poor response according to the early anatomic response. A good response to the treatment was considered the formation of foveal contour and full recovery of macular edema. Patients where macular edema was not fully resolved and/or foveal contour had not formed were classified as having poor response. Later, IVA and IVR were compared with each other in terms of response to treatment. Results: Evaluation was made of 67 eyes of 54 patients, comprising 31 (57.4%) females and 23 (42.6%) males with a mean age of 62.7 (7.3) years (range, 46-78 years). IVA was applied to 33 (49.3%) eyes and IVR to 34 (50.7%) eyes. In the IVA group, BCVA was determined as 0.75 (0.39) LogMAR pre-treatment, 0.53 (0.37) LogMAR at 1 month and 0.38 (0.30) LogMAR at 3 months (P<0.001 for each). CMT was measured as 400 (82) µm pre-treatment, 349 (95) µm at 1 month and 313 (79) µm at 3 months (P<0.001 for each). In the IVR group, BCVA was determined as 0.71 (0.34) LogMAR pre-treatment, 0.52 (0.34) LogMAR at 1 month and 0.39 (0.30) LogMAR at 3 months (P<0.001 for each). CMT was measured as 426 (92) µm pre-treatment, 365 (74) µm at 1 month and 323 (60) µm at 3 months (P<0.001 for each). A good response to treatment was determined in 24 eyes (72.7%) in the IVA group, and in 18 eyes (52.9%) in the IVR group. Although a good response to treatment was achieved at a higher rate in the IVA group, the difference was not statistically significant (P=0.09). Conclusion: Both visual and anatomic success was achieved with a 3-month loading dose in both the IVA and IVR groups. No statistically significant superiority was determined of one drug over the other in the 3-month period.

Keywords

• Aflibercept
• Ranibizumab
• Diabetic macular edema

Kaynakça

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