Efficacy and Safety of Ranibizumab Intravitreal Injections versus Laser Photocoagulation in Patients with Diabetic Macular Edema

Fadia T. Ahmed^1, , Najah K.M. Al Quriashi² and Ibrahim A. Majeed¹

¹Clinical Pharmacy Department, College of Pharmacy/ Baghdad University, Baghdad, Iraq

²Ophthalmology Department, College of Medicine/ Baghdad University, Baghdad, Iraq

Cite this paper:
Fadia T. Ahmed, Najah K.M. Al Quriashi and Ibrahim A. Majeed. Efficacy and Safety of Ranibizumab Intravitreal Injections versus Laser Photocoagulation in Patients with Diabetic Macular Edema. American Journal of Pharmacological Sciences. 2014; 2(4):72-76. doi: 10.12691/ajps-2-4-3

Abstract

Objective: Diabetic macular edema (DME) is a swelling of the retina resulting from leakage of fluid from blood vessels within the macula (the centre of the retina), it involves retinal thickening and formation of hard exudates that occurs secondary to diabetic retinopathy. The aim of the study was to evaluate the safety and efficacy of ranibizumab versus laser therapy in DME patients. Methods: A randomized controlled open labeled clinical trial with 4 months duration was performed. 40 Patients with DME were randomly allocated to receive either ranibizumab 0.5mg intravitreal injection monthly for three months or laser photocoagulation at baseline and were evaluated at baseline and one month after completing their treatments. Clinical assessment was done by measuring best corrected visual acuity (BCVA), central retinal thickness (CRT), and monitoring of the adverse events. Results: Ranibizumab was superior to laser (P=0.0001) in improving BCVA letter score, mean change from baseline to the end of the study was (+8.75 vs +2.75), with significant increase in VA for both ranibizumab (P < 0.0001) and laser (P = 0.005). The mean CRT was significantly reduced from baseline with ranibizumab (-126.4μm) versus laser (-67.85 μm) both with significant change (P<0.0001). Ranibizumab was better in reducing CRT (P=0.0003). No endophthalmitis and no clinically significant increased intraocular pressure (IOP) for both ranibizumab and laser arms. One case of cataract was reported in laser arm. Other adverse events include eye pain, conjunctival hemorrhage (in both arms), increased lacrimation, foreign body sensation and eye floaters (in ranibizumab arm) and eye pruritus (in the laser arm). There were no systemic adverse events and no deaths reported. Conclusion: Ranibizumab provided significantly superior BCVA and CRT improvement over laser therapy. It had a good safety outcome similar to the established safety profile of ranibizumab. It was well tolerated in DME.

Keywords:
ranibizumab diabetic macular edema laser photocoagulation

This work is licensed under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

References:

[1]	Klein R, Knudtson MD, Lee KE, et al. The Wisconsin Epidemiologic Study of Diabetic Retinopathy XXIII: the twentyfive- year incidence of macular edema in persons with type 1 diabetes. Ophthalmology 2009; 116: 497-503.
[2]	Johnson MW. Etiology and treatment of macular edema. Am J Ophthalmol 2009; 147: 11-21.
[3]	Early Treatment Diabetic Retinopathy Study Research Group, Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol 1985; 103: 1796-1806.
[4]	Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology 2008; 115: 1447-1449.
[5]	M. Saeed, D. Parmar, D. Mchugh. Frequency-doubled Nd:YAG laser for the treatment of exudative diabetic maculopathy. Eye 2001; 15: 712-718.
[6]	Aiello LP, Avery RL, Arrigg PG, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med 1994; 331: 1480-1487.
[7]	Aiello LP, Bursell SE, Clermont A, et al. Vascular endothelial growth factor-induced retinal permeability is mediated by protein kinase C in vivo and suppressed by an orally effective beta-isoform-selective inhibitor. Diabetes 1997; 46: 1473-1480.
[8]	Poulaki V. Hypoxia in the pathogenesis of retinal disease. In Retinal Vascular Disease. Joussen AM, Gardner TW, Kirchhof B, Ryan SJ, Eds. Berlin, Germany, Springer, 2007, 121-138.
[9]	Ferrara N, Damico L, Shams N, et al. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina 2006; 26: 859-70.
[10]	Jain A, Varshney N, Smith C. The Evolving treatment options for diabetic macular edema. International Journal of Inflammation 2013; Vol 2013: 1-10.
[11]	Stefa´nsson E. Diabetic macular edema. Saudi Journal of Ophthalmology 2009; 23: 143-148.
[12]	Massin P, Bandello F, Garweg J, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE study): a 12-month, randomized, controlled, doublemasked, multicenter phase II study. Diabetes Care 2010; 33: 2399-405.
[13]	Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011; 118(4): 615-625.
[14]	Gregori NZ, Feuer W, Rosenfeld PJ. Novel method for analyzing snellen visual acuity measurements. Retina 2010; Jul-Aug; 30(7): 1046-1050.
[15]	Peter K. Kaiser MD. Prospective evaluation of visual acuity assessment: A comparison of snellen versus ETDRS charts in clinical practice (an AOS thesis). Trans Am Ophthalmol Soc 2009; 107: 311-324.
[16]	Huang D, Swanson EA, Lin CP, et al: Optical coherence tomography. Science 1991; 254: 1178-81.
[17]	Bressler M.N, Edwards R.A, ANDREW N. Retinal thickness on stratus optical coherence tomography in people with diabetes and minimal or no diabetic retinopathy. American Journal of Ophthalmology 2008; May; 145(5):894-901.
[18]	Comyn O, Sivaprasad S, Peto T. A randomized trial to assess functional and structural effects of ranibizumab versus laser in diabetic macular edema (the LUCIDATE study). Am J Ophthalmol 2014; 157: 960-970.
[19]	Ohji M, Ishibashi T; REVEAL study group. Efficacy and safety of ranibizumab 0.5 mg as monotherapy or adjunctive to laser versus laser monotherapy in Asian patients with visual impairment due to diabetic macular edema: 12-month results of the REVEAL study. Invest Ophthalmol Vis Sci. 2012; 53: ARVO E-abstract 4664.
[20]	Diabetic Retinopathy Clinical Research Network, Elman MJ, Aiello LP, Beck RW, et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2010; 117: 1064-77.