EFFECT OF TOPICAL SODIUM DICLOFENAC AS ADJUVANT TO INTRAVITREAL BEVACIZUMAB INJECTION THERAPY ON VISUAL ACUITY INTRAOCULAR PRESSURE CHANGES IN PATIENTS WITH DIABETIC MACULAR EDEMA
Article Sidebar
-
Diabetic macular edema, bevacizumab, natrium diclofenac, visual acuity, IOP
Abstract
Introduction dan Aim: Diabetic Macular Edema (DME) in Diabetic Retinopathy (DR) patients might threaten the patient's visual acuity. Therefore, a robust DME treatment is needed to prevent sight threatening condition in DR patients. In this study, we intended to compare the effects of intravitreal administration of bevacizumab versus bevacizumab and topical natrium diclofenac in DR patients who developed DME.
Methods: This was a randomized controlled trial study with double blinds. Data were taken from April 2020 to June 2021 from the Dr. Sardjito Central General Hospital and the Dr. Suhardi Hardjolukito Indonesian Air Force Central Hospital, Yogyakarta. Our patients were assigned to a control group (intravitreal bevacizumab therapy only) and an intervention group (intravitreal bevacizumab and topical natrium diclofenac). Then, we evaluated best corrected visual acuity (LogMar) and intraocular pressure (IOP, mmHg) were recorded in both groups before and after therapy.
Results: A total of 38 eyes from 36 patients with naive DME were included in this study. Both treatment groups showed a statistically significant improvement in visual acuity after treatment bevacizumab (pre = 0.8±0.5; post = 0.6±0.5; p-value = 0.033) and bevacizumab and natrium diclofenac (pre = 0.9±0.5; post = 0.5±0.3; p-value = 0.004). In contrast to the above findings, the IOP in both groups did not show a significant change in IOP after therapy, bevacizumab (pre = 15.7±4.1; post = 15.6±4.2; p-value = 0.810) and bevacizumab and natrium diclofenac (pre = 16.0±4.5; post = 16.0±3.9; p-value = 0.868).
Conclusion: Our study showed that visual acuity was improved significantly in DME patients treated with either bevacizumab or bevacizumab and natrium diclofenac. This might be a valuable information on the improvement of DME therapy, given that no increased post-therapy IOP in patients treated topical natrium diclofenac.
Full text article
References
Ajlan, R. S., Silva, P. S. & Sun, J. K. Vascular endothelial growth factor and diabetic retinal disease. Semin. Ophthalmol., 2016. Taylor & Francis, 40-48.
Al-Abdullah, A. A., Nowilaty, S. R., Asghar, N., Al-Kharashi, A. S. & Ghazi, N. G. 2015. Intraocular pressure trends after intravitreal injections of anti-vascular endothelial growth factor agents for diabetic macular edema. Retina, 35, 440-448.
Arevalo, J. F. 2013. Diabetic macular edema: Current management 2013. World J. Diabetes, 4, 231.
Atmaca–Sonmez, P., Sonmez, K., Barr, C., Tezel, T. & Kaplan, H. 2005. Ocular Hypertension is More Common in Diabetic Macular Edema and Uveitis Than AMD Following Intravitreal Triamcinolone Acetonide Injection. Invest. Ophthalmol. Vis. Sci., 46, 3941-3941.
Ayalasomayajula, S. P. & Kompella, U. B. 2003. Celecoxib, a selective cyclooxygenase-2 inhibitor, inhibits retinal vascular endothelial growth factor expression and vascular leakage in a streptozotocin-induced diabetic rat model. Eur. J. Pharmacol., 458, 283-289.
Bandello, F., Casalino, G., Loewenstein, A., Goldstein, M., Pelayes, D. & Parodi, M. B. 2014. Pharmacological approach to diabetic macular edema. Ophthalmic Res., 51, 88-95.
Bandello, F., Pognuz, R., Polito, A., Pirracchio, A., Menchini, F. & Ambesi, M. Diabetic macular edema: classification, medical and laser therapy. Semin. Ophthalmol., 2003. 251-258.
Bonnin, S., Tadayoni, R., Erginay, A., Massin, P. & Dupas, B. 2015. Correlation between ganglion cell layer thinning and poor visual function after resolution of diabetic macular edema. Invest. Ophthalmol. Vis. Sci., 56, 978-982.
Busch, C., Fraser-Bell, S., Iglicki, M., Lupidi, M., Couturier, A., Chaikitmongkol, V., Giancipoli, E., Rodríguez-Valdés, P. J., Gabrielle, P.-H. & Laíns, I. 2019. Real-world outcomes of non-responding diabetic macular edema treated with continued anti-VEGF therapy versus early switch to dexamethasone implant: 2-year results. Acta Diabetol., 56, 1341-1350.
Cavan, D., Makaroff, L., Da Rocha Fernandes, J., Sylvanowicz, M., Ackland, P., Conlon, J., Chaney, D., Malhi, A. & Barratt, J. 2017. The diabetic retinopathy barometer study: global perspectives on access to and experiences of diabetic retinopathy screening and treatment. Diabetes Res. Clin. Pract., 129, 16-24.
Chatziralli, I., Kazantzis, D., Theodossiadis, G., Theodossiadis, P. & Sergentanis, T. N. 2021. Retinal layers changes in patients with diabetic macular edema treated with intravitreal anti-VEGF agents: long-term outcomes of a spectral-domain OCT study. Ophthalmic Res., 64, 230-236.
Cho, N., Shaw, J., Karuranga, S., Huang, Y. D., Da Rocha Fernandes, J., Ohlrogge, A. & Malanda, B. 2018. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res. Clin. Pract., 138, 271-281.
Choi, M. Y. & Kwon, J.-W. 2020. Risk factors for ocular hypertension after intravitreal dexamethasone implantation in diabetic macular edema. Sci. Rep., 10, 1-6.
De Vries, V. A., Bassil, F. L. & Ramdas, W. D. 2020. The effects of intravitreal injections on intraocular pressure and retinal nerve fiber layer: A systematic review and meta-analysis. Sci. Rep., 10, 1-10.
Ehrlich, R., Harris, A., Ciulla, T. A., Kheradiya, N., Winston, D. M. & Wirostko, B. 2010. Diabetic macular oedema: physical, physiological and molecular factors contribute to this pathological process. Acta Ophthalmol. (Copenh.), 88, 279-291.
Elbendary, A. M. & Shahin, M. M. 2011. Intravitreal diclofenac versus intravitreal triamcinolone acetonide in the treatment of diabetic macular edema. Retina, 31, 2058-2064.
Ghanbari, H., Kianersi, F., Sonbolestan, S. A., Abtahi, M.-A., Akbari, M., Abtahi, Z.-A. & Abtahi, S.-H. 2017. Intravitreal Diclofenac plus Bevacizumab versus Bevacizumab alone in treatment-naive diabetic macular edema: a randomized double-blind clinical trial. Int. Ophthalmol., 37, 867-874.
Gillies, M. C., Sutter, F. K., Simpson, J. M., Larsson, J., Ali, H. & Zhu, M. 2006. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology, 113, 1533-1538.
Glassman, A. R., Wells Iii, J. A., Josic, K., Maguire, M. G., Antoszyk, A. N., Baker, C., Beaulieu, W. T., Elman, M. J., Jampol, L. M. & Sun, J. K. 2020. Five-year outcomes after initial aflibercept, bevacizumab, or ranibizumab treatment for diabetic macular edema (Protocol T Extension Study). Ophthalmology, 127, 1201-1210.
Heier, J. S., Bressler, N. M., Avery, R. L., Bakri, S. J., Boyer, D. S., Brown, D. M., Dugel, P. U., Freund, K. B., Glassman, A. R. & Kim, J. E. 2016. Comparison of aflibercept, bevacizumab, and ranibizumab for treatment of diabetic macular edema: extrapolation of data to clinical practice. JAMA Ophthalmol., 134, 95-99.
Kern, T. S., Miller, C. M., Du, Y., Zheng, L., Mohr, S., Ball, S. L., Kim, M., Jamison, J. A. & Bingaman, D. P. 2007. Topical administration of nepafenac inhibits diabetes-induced retinal microvascular disease and underlying abnormalities of retinal metabolism and physiology. Diabetes, 56, 373-379.
M. Joussen, A., Poulaki, V., Mitsiades, N., Kirchhof, B., Koizumi, K., Döhmen, S. & P. Adamis, A. 2002. Nonsteroidal anti?inflammatory drugs prevent early diabetic retinopathy via TNF?? suppression. FASEB J., 16, 438-440.
Maturi, R. K., Pollack, A., Uy, H. S., Varano, M., Gomes, A., Li, X.-Y., Cui, H., Lou, J., Hashad, Y. & Whitcup, S. M. 2016. Intraocular pressure in patients with diabetic macular edema treated with dexamethasone intravitreal implant in the 3-year MEAD study. Retina, 36, 1143-1152.
Michaelides, M., Kaines, A., Hamilton, R. D., Fraser-Bell, S., Rajendram, R., Quhill, F., Boos, C. J., Xing, W., Egan, C. & Peto, T. 2010. A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study): 12-month data: report 2. Ophthalmology, 117, 1078-1086. e2.
Nguyen, Q. D., Shah, S. M., Heier, J. S., Do, D. V., Lim, J., Boyer, D., Abraham, P., Campochiaro, P. A. & Group, R.-S. 2009. Primary end point (six months) results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) study. Ophthalmology, 116, 2175-2181. e1.
Pascolini, D. & Mariotti, S. P. 2012. Global estimates of visual impairment: 2010. Br. J. Ophthalmol., 96, 614-618.
Pinna, A., Blasetti, F., Ricci, G. D. A. & Boscia, F. 2017. Bromfenac eyedrops in the treatment of diabetic macular edema: a pilot study. Eur. J. Ophthalmol., 27, 326-330.
Rodrigues, M. W., Cardillo, J. A., Messias, A., Siqueira, R. C., Scott, I. U. & Jorge, R. 2020. Bevacizumab versus triamcinolone for persistent diabetic macular edema: a randomized clinical trial. Graefe's Archive for Clinical and Experimental Ophthalmology, 258, 479-490.
Russo, A., Costagliola, C., Delcassi, L., Parmeggiani, F., Romano, M. R. & Semeraro, F. 2013. Topical nonsteroidal anti-inflammatory drugs for macular edema. Mediators Inflamm., 2013.
Sasongko, M. B., Widyaputri, F., Agni, A. N., Wardhana, F. S., Kotha, S., Gupta, P., Widayanti, T. W., Haryanto, S., Widyaningrum, R. & Wong, T. Y. 2017. Prevalence of diabetic retinopathy and blindness in Indonesian adults with type 2 diabetes. Am. J. Ophthalmol., 181, 79-87.
Schmidt-Erfurth, U., Garcia-Arumi, J., Bandello, F., Berg, K., Chakravarthy, U., Gerendas, B. S., Jonas, J., Larsen, M., Tadayoni, R. & Loewenstein, A. 2017. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica, 237, 185-222.
Sivaprasad, S., Gupta, B., Crosby-Nwaobi, R. & Evans, J. 2012. Prevalence of diabetic retinopathy in various ethnic groups: a worldwide perspective. Surv. Ophthalmol., 57, 347-370.
Soheilian, M., Karimi, S., Ramezani, A., Montahai, T., Yaseri, M., Soheilian, R. & Peyman, G. A. 2015. Intravitreal diclofenac versus intravitreal bevacizumab in naive diabetic macular edema: a randomized double-masked clinical trial. Int. Ophthalmol., 35, 421-428.
Soheilian, M., Rabbanikhah, Z., Ramezani, A., Kiavash, V., Yaseri, M. & Peyman, G. A. 2010. Intravitreal bevacizumab versus triamcinolone acetonide for refractory uveitic cystoid macular edema: a randomized pilot study. J. Ocul. Pharmacol. Ther., 26, 199-206.
Tomi?, M., Vrabec, R., Polji?anin, T., Ljubi?, S. & Duvnjak, L. 2017. Diabetic macular edema: Traditional and novel treatment. Acta Clin. Croat., 56, 124-131.
Wells, J. A., Glassman, A. R., Ayala, A. R., Jampol, L. M., Bressler, N. M., Bressler, S. B., Brucker, A. J., Ferris, F. L., Hampton, G. R. & Jhaveri, C. 2016. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology, 123, 1351-1359.
Winegarner, A., Wakabayashi, T., Fukushima, Y., Sato, T., Hara-Ueno, C., Busch, C., Nishiyama, I., Shiraki, N., Sayanagi, K. & Nishida, K. 2018. Changes in retinal microvasculature and visual acuity after antivascular endothelial growth factor therapy in retinal vein occlusion. Invest. Ophthalmol. Vis. Sci., 59, 2708-2716.
Yasuda, K., Motohashi, R., Kotake, O., Nakagawa, H., Noma, H. & Shimura, M. 2016. Comparative effects of topical diclofenac and betamethasone on inflammation after vitrectomy and cataract surgery in various vitreoretinal diseases. J. Ocul. Pharmacol. Ther., 32, 677-684.
Authors
Copyright (c) 2023 Supanji Supanji, Widya Ramania, Melvina Nidya Sandra, Angela Nurini Agni, Suhardjo Suhardjo, Retno Ekantini, Muhammad Bayu Sasongko
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.