Diyabetik Maküla Ödeminde Unilateral ve Bilateral Uygulanan İntravitreal Ranibizumab Tedavisinin Anatomik ve Görsel Sonuçları

Abstract

Amaç: Diyabetik makula ödemi olan hastalarda unilateral ve bilateral uygulanan intravitreal ranibizumab tedavisinin anatomik ve görsel sonuçlarının karşılaştırılması amaçlanmıştır.

Materyal ve Metod:  Atatürk Üniversitesi Tıp Fakültesi Göz Hastalıkları Kliniği’nde Nisan 2012-Mayıs 2017 tarihleri arasında diyabetik makula ödemi (DMÖ) olan ve birer ay ara ile toplam 3 kez intravitreal ranibizumab (İVR) enjeksiyonu uygulanan hastaların dosyaları retrospektif olarak incelendi. Yaş, cinsiyet, diyabetin süresi, şikayetler ile ilk ranibizumab tedavisi arasındaki süre, uygulanan diğer tedaviler, takip süresi, göz içi basıncı, görme keskinliği (EDGK) kaydedildi. İstatistiksel analizlerde paired-t testi kullanıldı, p<0.05 olması anlamlı kabul edildi.

Bulgular: Çalışmaya; DMÖ olan 43’ü erkek, 37’si kadın, yaşları 59-82 olan, 80 hastanın 120 gözü dahil edildi. 40 hasta unilateral, 40 hasta bilateral DMÖ nedeniyle tedavi edildi. İlk kez tedavi gören hastalara birer ay ara ile toplam 3 kez İVR enjeksiyonu uygulandı. Ortalama diyabet süresi unilateral olgularda 10.6 yıl, bilateral olgularda 11,2 yıl idi. Şikayetler ile ilk ranibizumab tedavisi arasındaki süre, unilateral olgularda 21gün, bilateral olgularda 18gün idi. Takip süresi unilateral olgularda ortalama 6.3 ay, bilateral olgularda 6.7 ay idi. Başvuru anında ortalama EDGK unilateral olgularda 0.19±0.23(Snellen), bilateral olgularda sağ gözlerde 0.21±1.35, sol gözlerde 0.29±0.76 (p˃0,05), 6.ayda ise sırasıyla 0.2±0.32, 0.53±2.59, 0.49±1.92 (p˃0,05)idi. OCT incelemesinde; başvuru anında ortalama santral foveolar kalınlığı (SFK) unilateral olgularda 458.1±177.6µm, bilateral olgularda sağ gözlerde 412.5±233.8µm, sol gözlerde 463.2±721.9 µm (p˃0,05), tedavi sonrası 6.ayda ise sırasıyla; 301.3±129.6µm, 297.3±316, 280.1±317.3 µm (p˃0,05)idi.

Sonuç: Unilateral İVR uygulanan hastaların diğer gözlerinde SFK’ında ve görme düzeyinde anlamlı bir değişiklik saptamadık. Bilateral ve unilateral İVR uygulamaları kıyaslandığında, EDGK ve SFK’ındaki değişim açısından istatistiksel olarak anlamlı farkın olmadığı ve bilateral İVR uygulamasının sinerjistik etkisinin olmadığı kanaatindeyiz.

Keywords

• Diyabetik makula ödemi,görme keskinliği,intravitreal ranibizumab,santral foveolar kalınlık

Anatomical and Visual Outcomes of Unilateral and Bilateral Intravitreal Ranibizumab Treatment Applied in Diabetic Macular Edema

Abstract

Aim: Comparison of anatomical and visual results of unilateral and bilateral intravitreal ranibizumab treatment in patients with diabetic macular edema.

Material-Method: The files of patients with diabetic macular edema (DME) who underwent intravitreal ranibizumab (IVR) for a total of 3 times between April 2012 and May 2017 were reviewed retrospectively at Ataturk University Ophtalmology Department. Age, gender, duration of diabetes, duration between complaints and first ranibizumab treatment, other treatments, follow-up period, intraocular pressure, best corrected visual acuity (BCVA) were recorded. The paired-t test was used for statistical analysis, p<0.05 was considered significant.

Results: 120 eyes of 80 patients with DME, whose 43 were males, 37 were females and 59-82 years old were included. 40 patients were treated unilaterally because of DME and 40 patients were treated bilaterally due to DME. Mean BCVA was 0.19±0.23 (Snellen) in unilateral cases, 0.21±1.35 in the right eye, 0.29±0.76 in the left eye in bilateral case p˃0.05) at the time of admission, in the 6^thmonth, the mean values ​​were 0.42±0.32, 0.53±2.59, 0.49±1.92 (p˃0.05), respectively. Mean central foveolar thickness (CFT) was 458.1±177.6 μm in unilateral cases, 412.5±233.8μm in right eye and 463.2±721.9μm in left eye (p˃0,05) in bilateral cases. After treatment, at the 6^th month, respectively; mean CFT was 301.3±129.6 μm, 297.3±316 µm, 280.1±317.3 μm (p˃0.05).

Conclusion: We didn’t determine any significant change in CFT and BCVA in the other eyes of the patients applied unilateral IVR. When comparing unilateral IVR with bilateral IVR, we conclude that there isn’t statistically significant difference in terms of changes in BCVA and CFT and there isn’t synergistic effect of bilateral IVR administration.

Keywords

• Diabetic macular edema,visual acuity,intravitreal ranibizumab,central macular thickness

References

1. 1. Rehak J, Rehak M: Branch Retinal Vein Occlusion: Pathogenesis, Visual Prognosis, and Treatment Modalities Current Eye Research. 2008;33:111-131
2. 2. Davidson J K. Clinical diabetes mellitus, diabetic eye disease. Thime Medica Publishers 1991;427-44.
3. 3. Ayyıldız O, Durukan AH, Ozgurtas T, Gunal A. A Comparison of Intravitreal Bevacizumab and Steroid Activity in an Experimental Uveitis Model. Curr Eye Res. 2015;40(12):1261-8.
4. 4. SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study report 6. Arch Ophthalmol. 2009;127:1115-28 20
5. 5. Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XV. The long-term incidence of macular edema. Ophthalmology. 1995;102:7-16.
6. 6. Klein R, Knudtson MD, Lee KE, Gangnon R, Klein BE. The Wisconsin Epidemiologic Study of Diabetic Retinopathy XXIII: the twenty-five-year incidence of macular edema in persons with type 1 diabetes. Ophthalmology. 2009;116:497-503
7. 7. Fong AH, Lai TY. Long-term effectiveness of ranibizumab for age-related macular degeneration and diabetic macular edema. Clin Interv Aging 2013;8:467-83.
8. 8. Chun DW, Heier JS, Topping TM, Duker JS, Bankert JM. A Pilot Study of Multiple İntravitreal Injections of Ranibizumab in Patients with Center –Involving Clinically Significant Diabetic Macular Edema. Ophthalmology. 2006;113;1706-1712.

9. 9. Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L et al. RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 2012;119:789-801.
10. 10. Nguyen QD, Shah SM, Heier JS, Do DV, Lim J, Boyer D et al. READ-2 Study Group. Primary End Point (Six Months) Results of the ranibizumab for edema of the macula in diabetes (READ-2) study. Ophthalmology 2009;116:2175-81.
11. 11. Bakri, S.J., Snyder, M.R., Reid, J.M., Pulido JS, Singh RJ. Pharmacokinetics of intravitreal ranibizumab (Lucentis). Ophthalmology. 114: 2179–2182, 2007.
12. 12. Wu Z, Sadda SR. Effects on the contralateral eye after intravitreal bevacizumab and ranibizumab injections: a case report. Ann Acad Med Singapore 2008;37:591–593
13. 13. Acharya, Nisha R, Wantanee S, Ying Q, Kevin H, Salena LM OD Bılateral Effect Of Unılateral Ranıbızumab In Patıents Wıth Uveıtıs-Related Macular EDEMA Retina: October 2011 - Volume 31 - Issue 9 - p 1871-1876.
14. 14. Zehetner C., Kirchmair R., Huber S., Kralinger MT., Kieselbach GF. Plasma levels of vascular endothelial growth factor before and after intravitreal injection of bevacizumab, ranibizumab and pegaptanib in patients with age-related macular degeneration, and in patients with diabetic macular oedema. Br. J. Ophthalmol. 97:454–459, 2013.
15. 15. Barbazetto IA, Saroj N, Shapiro H, Wong P, Ho AC, Freund KB. Incidence of new choroidal neovascularization in fellow eyes of patients treated in the MARINA and ANCHOR trials. Am J Ophthalmol 2010;149:939–946.
16. 16. Bakbak B, Ozturk BT, Gonul S, Yilmaz M, Gedik S. Comparison of the effect of unilateral bevacizumab and ranibizumab on diabetic macular edema of the fellow eye. J Ocul Pharmacol Ther 2013;29(8):728-32.
17. 17. Sül S, Karalezli A. Turkiye Klinikleri J Ophthalmol.2018-60714