Cortés-Quezada S, Arévalo-Simental DE, Cisneros-Gómez S, Navarro-Sánchez CD, Márquez-Cardona ET, Jacinto-Buenrostro J, Ontiveros-Pérez D, Mendoza-Adam G, Soria-Orozco CL, Roig-Melo EA

Language: Spanish
References: 18
Page: 5-10
PDF size: 552.87 Kb.

ABSTRACT

Introduction. Since the appearance of the treatment for Diabectic Macular Edema with antiangiogenics more than 10 years ago, different schedules of injection have been used, such as the monthly application, as needed or Treat and Extend. However, the difficulty of the monthly tomographic follow-up has complicated in real life the outline with attachment to the patient and good results. The objective is to demonstrate the comparable efficacy of the combination of Ranibizumab (0.05 mg/0.05 ml) with preservative-free Triamcinolone Acetonide (1 mg/0.05 ml) intravitreal in bimonthly injection schedule versus as needed.
Material and Methods. Prospective, randomized, experimental, case-control study. 40 patients with Diabetic Macular Edema were included. 20 patients were randomized under a fix injection regimen with 4 initial load monthly dosages, and after that bimonthly until the 12months treatment. 20 patients under an identical schedule, but PRN after month 5 with default retreatment criteria. This study was done in the Medical and Surgical Retina in the Civil Hospital of Guadalajara from February 2016 to February 2017. Ages, 18 to 80 years old. Best Corrected Visual Acuity (BCVA) between 20/40 and 20/400 (73 to 25 ETDRS letters). Central retinal width ≥300 µm (Measured with Optical Coherence Tomography - OCT). Diagnosis of Diabetes Mellitus Type I or II. Main measuring: Proportion of patients who gain more or equal to 15 letters of BCVA in 12 months. Secondary measuring: The change on the central macular width, letters gained according to the ETDRS, average number of injections in 12 months, need for Focal Laser, cataract progression under the LOCS III classification, glaucoma development, and other complications related to intravitreal injection. A Student's T-test was performed using GraphPad. .
Results. 65% of the patients under a bimonthly regimen, and 60 % of the patients under the PRN regimen gained equal or more than 15 letters according to the ETDRS in month 12 (p=0.46) The average of injection in the bimonthly regimen were 8, while in the PRN regimen it was 7 +/- 1.029 (p=0.0001). The bimonthly regimen required 40% laser in comparison to 35% on the PRN (p=0001), both regimens presented a 35% cataract progression (p=1.000). No patient had letter loss, development of glaucoma, intraocular hypertension, nor endophthalmitis.
Discussion. The bimonthly regimen is equally effective and safe as a Diabetic Macular Edema treatment in comparison to the PRN regimen without the need of performing an Optical Coherence Tomography monthly.

REFERENCES

1. Aroca PR, Salvat M, Fernández J, Mendez I. Risk factors for diffuse and focal macular edema. J Diabetes Compl. 2004;18:211-215.

2. Moradi A, Sepah YJ, Sadiq MA, Nasir H, Kherani S, Sophie R, Do DV, Nguyen QD. Vascular endothelial growth factor trap-eye (Aflibercept) for the management of diabetic macular edema. World J Diabetes. 2013 Dec 15;4(6):303-309.

3. Ferris III FL, Patz A. Macular edema. A complication of diabetic retinopathy. Surv. Ophthalmol. 1984;28(Suppl):452-461.

4. Su Na Lee, Jay Chhablani, et al. Characterization of Microaneurysm Closure After Focal Láser Photocoagulation in Diabetic Macular Edema. Am J Ophthalmol 2013;155:905–912.

5. Chen E, Looman M, et al. Burden of illness of diabetic macular edema: literature review. Curr Med Res Opin. 2010;26:1587-1597.

6. Wild S, Roglic G, et al. Global Prevalence of diabetes estimates for the year 2000 and projection for 2030. Diabetes Care. 2004;27_1047-1053.

7. American Academy of Ophthalmology Retina Panel. Preferred Practice Pattern guidelines: Diabetic Retinopathy. American Academy of Ophthalmology. San Francisco CA;2010.

8. The Royal College of Ophthalmologists Guidelines for diabeticretinopathy. 2005. http://www.rcophth.ac.uk/page.asp?section=451& sectionTitle=Clinical + Guidelines 2011.

9. Klein R, Klein BE, Moss SE, Cruickshanks KJ. 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;105:1801–1815.

10. Paul Mitchell, MD et al The RESTORE Study Group. Ranibizumab Monotherapy or Combined with Láser versus Láser Monotherapy for Diabetic Macular Edema. Ophthalmology 2011;118:615–625.

11. Elman MJ, Aiello LP, Beck RW, Bressler N, Bressler Sb, Edwards AR, et al. Randomized trial evaluating ranibizumab plus prompt or deferred láser or triamcinolone plus prompt láser for diabetic macular edema. Ophthalmology 2010;117:1064–1077.

12. Funatsu H, Yamashita H, Noma H, Nimura T, Yamashita T, Hori S. Increased levels of vascular endothelial growth factor and interleukin-6 in the aqueous humor of diabetics with macular edema. Am J Ophthalmol. 2001;133:70-77

13. Funatsu H, Yamashita H, et al. Vitreous levels of interleukin-6 and vascular endothelial growth factor arerelat ed to diabetc macular edema. Ophthalmology. 2003;110:1690-1696.

14. Bahgat N, Grigorian RA, et al. Diabetic macular edema pathogenesis and treatment. Surv Ophthalmol. 2009;54:1-32.

15. Novartis Pharma AG. Summary of Product Characteristics 2011. Novartis Pharma AG: Basel, Switzerl and 2011. http://emc.medicines.org.uk/em/assets/c/html/d iisplaydoc.asp?documentid=19409.

16. Massin P, Bandello F, 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;33:2399-2405.

17. Nguyen QD, Shah SM, et al. Two-year outcomes of the Ranibizumab for Edema of the Macula in Diabetes (READ-2) study. Ophthalmology. 2010;117:2146-2151.

18. 18.- Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol 1985;103:1796-1806.