Title: Comparative Study of Intravitreal Ranibizumab with and Without Nepafenac Eye Drops for Center Involving Diabetic Macular Edema

Authors: Mohsen Abou Shousha MD, Hany Ahmed Helaly MD

 DOI:  http://dx.doi.org/10.18535/jmscr/v3i10.21

Abstract

Purpose: to compare intravitreal ranibizumab with and without Nepafenac eye drops as a treatment for center involving diabetic macular edema.

Methods:This is a randomized, comparative, double masked, interventional prospective clinical study that included 60 eyes with center involving diabetic macular edema and had good metabolic control, randomly assigned into 2 groups (A and B). Patients had monthly intra-vitreal injection of 0.5 mg ranibizumab (Lucentis; Novartis, Basel, Switzerland and Genentech Inc., South San Francisco, CA) for the first three months. In the next nine months, reinjection was done according to predetermined reinjection criteria. Group B had in addition topical Nepafenac eye drops 0.1% (Nevanac; Alcon Labs, Fort Worth, TX, USA), three times daily for twelve months.

Results:As regards the mean central macular thickness (CMT) at 12 months, it was 320 + 63 microns and 310 + 71 microns for group A and B respectively (p = 0.311). The mean number of injections in the 12 months follow up period was 6.9 + 1.1 (range from 5 to 9) and 5.9 + 1.18 (range from 4 to 8) for group A and group B respectively (p = 0.002).

Conclusion:Nepafenac 0.1% eye drops three times daily may be a good adjuvant to intravitreal ranibizumab in the treatment of diabetic macular edema that decrease the number of ranibizumab injections needed for those patients.

Keywords: Diabetic Macular Edema, Nepafenac, Ranibizumab, Lucentis; Intravitreal Injection.

References

1.      Diabetes fact sheet No. 312 [article online 2009]. Available from: http://www.who.int/mediacentre/factsheets/fs312/en/ Accessed 20 December 2009.

2.      Resnikoff S, Pascolini D, Etya'ale D, et al. Global data on visual impairment in the year 2002. Bull World Health Organ 2004; 82:844–51.

3.      Klein R, Klein BE, Moss SE, et al. The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XVII. The 14-year incidence and progression of diabetic retinopathy and associated risk factors in type 1 diabetes. Ophthalmology 1998;105:1801–15.

4.      King H, Aubert RE, Herman WH. Global burden of diabetes, 1995–2025: prevalence, numerical estimates, and projections. Diabetes Care 1998;21:1414–31.

5.      Ahmed N, Arafa S, Amin G. The Epidemiology of Diabetes Mellitus in Egypt : Results of a National Survey. The Egypt J Community Med 2010; 28:29-43.

6.      Roy MS, Klein R, O'Colmain BJ, et al. The Prevalence of diabetic retinopathy among Adult Type 1 Diabetic Persons in the U.S.A. Arch Ophthalmol 2004; 122:546-51.

7.      Cahill M, Halley A, Codd M, et al. Prevalence of diabetic retinopathy in patients with diabetes mellitus diagnosed after the age of 70 years. Br J Ophthalmol 1997; 81:218–22.

8.      Brown JB, Pedula KL, Summers KH. Diabetic retinopathy: Contemporary prevalence in a well-controlled population. Diabetes Care 2003;26:2637-42.

9.      Klein R, Klein BEK, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XV. The long-term incidence of macular edema. Ophthalmology 1995; 102:7-16.

10.  Lucentis, Summary of product characteristics. Section 4.1 Therapeutic indications. 2013. Available at: http://www.ema.europa.eu/ docs/en_GB/document_library/EPARProduct_Information/human-/000715/WC500043546.pdf.  Accessed November 24,2013.

11.  Schmidt-Erfurth U, Lang GE, Holz FG, et al. Three-Year Outcomes of Individualized Ranibizumab Treatment in Patients with Diabetic Macular Edema.The RESTORE Extension Study. Ophthalmology 2014; 121(5): 1045-53.

12.  Kim SJ, Flach AJ, and Jampol LM. Nonsteroidal anti-inflammatory drugs in ophthalmology. SurvOphthalmol 2010; 55(2):108–33.

13.  Walters T, Raizman M, Ernest P, et al. In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac. J Cataract Refract Surg 2007; 33(9): 1539–45.

14.  Heier JS, Awh CC, Busbee BG, et al. Vitreous non-steroidal anti-inflammatory drug concentrations and prostaglandin E2 levels in vitrectomy patients treated with ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1%. Retina 2009; 29 (9): 1310–3.

15.  Elbendary AM and Shahin MM. Intravitreal diclofenac versus intravitreal triamcinolone acetonide in the treatment of diabetic macular edema. Retina 2011; 31(10): 2058–64.

16.  Callanan D, Williams P. Topical nepafenac in the treatment of diabetic macular edema. ClinOphthalmol 2008; 2(4): 689–2.

17.  Kern TS, Miller CM, Du Y, et al. Topical Administration of Nepafenac Inhibits Diabetes-Induced Retinal Microvascular Disease and Underlying Abnormalities of Retinal Metabolism and Physiology. Diabetes 2007; 56:373-9.

18.  AbouShousha MA, Sabry HN. Retinal Measurements: Comparison Between Spectral Domain and Time Domain Optical Coherence Tomography. Delta J Ophthalmol 2009; 10:91-5.

19.  Lindstrom R, Kim T. Ocular permeation and inhibition of retinal inflammation: an examination of data and expert opinion on the clinical utility of nepafenac. Curr Med Res Opin. 2006;22(2):397–404.

Corresponding Author

Hany Ahmed Helaly MD

Ophthalmology Department, Faculty of Medicine

Alexandria University, Egypt

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