One year clinical observation of dexamethasone intravitreal implant (Ozurdex) in the treatment of macular edema secondary to retinal vein occlusion_Chinese Journal of Ocular Fundus Diseases

Authors：

Gu Xiaoya , Dai Hong ,  Yu Xiaobing

Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Beijing 100730, China;

Corresponding author：

Yu Xiaobing, Email: yuxiaobing@sina.com

Keywords：

Dexamethasone/therapeutic use; Retinal vein occlusion/drug therapy; Macular edema/drug therapy

DOI：

10.3760/cma.j.issn.1005-1015.2018.03.004

Video：

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Objective To evaluate the efficacy and safety of dexamethasone intravitreal implant (Ozurdex) in the treatment of macular edema (ME) secondary to retinal vein occlusion (RVO). Methods Thirty-nine patients (39 eyes) with ME secondary to RVO were enrolles in this study. Of the patients, 27 were male and 12 were female. The mean age was (41.9±16.3) years. The mean course of disease was (5.0±5.3) months. The best corrected visual acuity (BCVA), intraocular pressure and optical coherence tomography (OCT) were performed. BCVA was measured by Early Treatment Diabetic Retinopathy Study charts. Central macular thickness (CMT) was measured by OCT. The mean BCVA was (13.4±15.3) letters. The mean intraocular pressure (IOP) was (14.1±2.8) mmHg (1 mmHg=0.133 kPa). The mean CMT was (876.1±437.9) μm. Of the 39 eyes, 33 were central RVO, 6 were branch RVO. Patients were categorized into ischemic (18 eyes)/non-ischemic (21 eyes) groups and previous treatment (22 eyes)/treatment naïve (17 eyes) groups. All eyes underwent intravitreal 0.7 mg Ozurdex injections. BCVA, IOP and CMT were assessed at 1, 2, 3, 6, 9, 12 months after injection. Three months after injection, intravitreal injections of Ozurdex, triamcinolone acetonide or ranibizumab could be considered for patients with ME recurrence or poor treatment effects. Change of BCVA, IOP and CMT were evaluated with paired t test. The presence of ocular and systemic adverse events were assessed. Results BCVA, IOP significantly increased and CMT significantly decreased at 1 month after injection compared to baseline in all groups (t=3.70, 3.69, 4.32, 3.08, 4.25, 6.09, 6.25, 4.02, 5.49, 8.18, 6.54, 5.73; P＜0.05). Two months after injection, change of BCVA, IOP and CMT was most significant (t=4.93, 6.80, 6.71, 5.53, 4.97, 5.89, 5.13, 7.68, 7.31, 8.67, 8.31, 5.82; P＜0.05). Twelve months after injection, there was no statistical difference regarding BCVA of ischemic RVO group and previous treatment group, compared to baseline (t=1.86, 0.67; P＞0.05); BCVA of non-ischemic RVO group and treatment naïve group significantly increased compared to baseline (t=2.27, 2.30; P＜0.05); there was no statistical difference regarding IOP in all groups (t=0.30, 0.13, 0.64, 1.53; P＞0.05);however, CMT significantly decreased in all groups (t=4.60, 3.26, 3.00, 4.87; P＜0.05). Twenty-seven eyes (69.2%) experiences ME recurrence (4.5±1.5) months after injection. Most common side-effect was secondary glaucoma. 41.0% eyes had IOP more than 25 mmHg, most of which were lowered to normal range with use of topical IOP lowering drugs. Four eyes (10.3%) presented with significant cataract progression and needed surgical treatment, all were central RVO eyes. No serious ocular or systemic adverse events such as vitreous hemorrhage, retinal detachment or endophthalmitis were noted. Conclusions Intravitreal injection of Ozurdex for patients with ME secondary to RVO is effective in increasing BCVA and lowering CMT in the first few months. Significant treatment effect could be seen at 1 month after injection and was most significant at 2 months after injection. The long-term vision of eyes in non-ischemic RVO group and treatment naïve group are better. 69.2% eyes experience ME recurrence at 4 months after injection. Short term adverse events were mostly secondary glaucoma and long term adverse events are mostly cataract progression.

Citation： Gu Xiaoya, Dai Hong, Yu Xiaobing. One year clinical observation of dexamethasone intravitreal implant (Ozurdex) in the treatment of macular edema secondary to retinal vein occlusion. Chinese Journal of Ocular Fundus Diseases, 2018, 34(3): 221-227. doi: 10.3760/cma.j.issn.1005-1015.2018.03.004 Copy

1.	Noma H, Funatsu H, Yamasaki M, et al. Pathogenesis of macular edema with branch retinal vein occlusion and intraocular levels of vascular endothelial growth factor and interleukin-6[J]. Am J Ophthalmol, 2005, 140(2): 256-261. DOI: 10.1016/j.ajo.2005.03.003.
2.	Kuppermann BD, Blumenkranz MS, Haller JA, et al. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema[J]. Arch Ophthalmol, 2007, 125(3): 309-317. DOI: 10.1001/archopht.125.3.309.
3.	Leopold IH. Nonsteroidal and steroidal anti-inflammatory agents[M]//Sears ML, Tarkkanen A. Surgical pharmacology of the eye. New York: Raven Press, 1985: 83-133.
4.	Nauck M, Karakiulakis G, Perruchoud AP, et al. Corticosteroids inhibit the expression of the vascular endothelial growth factor gene in human vascular smooth muscle cells[J]. Eur J Pharmacol, 1998, 341(2-3): 309-315.
5.	Haller JA, Bandello F, Belfort R, et al. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion[J]. Ophthalmology, 2010, 117(6): 1134-1146. DOI: 10.1016/j.ophtha.2010.03.032.
6.	Li X, Wang N, Liang X, et al. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study[J]. Graefe's Arch Clin Exp Ophthalmol, 2018, 256(1): 59-69. DOI: 10.1007/s00417-017-3831-6.
7.	Capone A, Singer MA, Dodwell DG, et al. Efficacy and safety of two or more dexamethasone intravitreal implant injections for treatment of macular edema related to retinal vein occlusion (SHASTA study)[J]. Retina, 2014, 34(2): 342-351. DOI: 10.1097/IAE.0b013e318297f842.
8.	Matonti F, Meyer F, Guigou S, et al. Ozurdex in the management of the macular edema following retinal vein occlusion in clinical practice[J]. Acta Ophthalmol, 2013, 91(7): 584-586. DOI: 10.1111/aos.12190.
9.	Pommier S, Meyer F, Guigou S, et al. Long-term real-life efficacy and safety of repeated Ozurdex injections and factors associated with macular edema resolution after retinal vein occlusion: the REMIDO 2 study[J]. Ophthalmologica, 2016, 236(4): 186-192. DOI: 10.1159/000452896.
10.	Haller JA, Bandello F, Belfort R, et al. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results[J]. Ophthalmology, 2011, 118(12): 2453-2460. DOI: 10.1016/j.ophtha.2011.05.014.
11.	Meyer LM, Schonfeld CL. Secondary glaucoma after intravitreal dexamethasone 0.7 mg implant in patients with retinal vein occlusion: a one-year follow-up[J]. J Ocul Pharmacol Ther, 2013, 29(6): 560-565. DOI: 10.1089/jop.2012.0253.
12.	Coscas G, Augustin A, Bandello F, et al. Retreatment with Ozurdex for macular edema secondary to retinal vein occlusion[J]. Eur J Ophthalmol, 2013, 24(1): 1-9. DOI: 10.5301/ejo.5000376.
13.	Ferrini W, Ambresin A. Intravitreal dexamethasone implant for the treatment of macular edema after retinal vein occlusion in a clinical setting[J]. Klin Monbl Augenheilkd, 2013, 230(4): 423-426. DOI: 10.1055/s-0032-1328388.
14.	Chang-Lin JE, Attar M, Acheampong AA, et al. Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant[J]. Invest Ophthalmol Vis Sci, 2011, 52(1): 80-86. DOI: 10.1167/iovs.10-5285.
15.	Ramezani A, Entezari M, Moradian S, et al. Intravitreal triamcinolone for acute central retinal vein occlusion: a randomized clinical trial[J]. Graefe’s Arch Clin Exp Ophthalmol, 2006, 244(12): 1601-1606. DOI: 10.1007/s00417-006-0348-9.
16.	Ip MS, Gottlieb JL, Kahana A, et al. Intravitreal triamcinolone for the treatment of macular edema associated with central retinal vein occlusion[J]. Arch Ophthalmol, 2004, 122(8): 1131-1136. DOI: 10.1001/archopht.122.8.1131.
17.	Malclès A, Dot C, Voirin N, Vié A L, et al. Safety of intravitreal dexamethasone implant (Ozurdex): The SAFODEX study[J]. Retina, 2017, 37(7): 1352-1359. DOI: 10.1097/IAE.0000000000001369.
18.	Scott IU, Ip MS, VanVeldhuisen PC, et al. 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[J]. Arch Ophthalmol, 2009, 127(9): 1115-1128. DOI: 10.1001/archophthalmol.2009.233.
19.	Gu X, Yu X, Song S, et al. Intravitreal dexamethasone implant versus intravitreal ranibizumab for the treatment of macular edema secondary to retinal vein occlusion in a Chinese population[J]. Ophthalmic Res, 2017, 58(1): 8-14. DOI: 10.1159/000458534.

1. Noma H, Funatsu H, Yamasaki M, et al. Pathogenesis of macular edema with branch retinal vein occlusion and intraocular levels of vascular endothelial growth factor and interleukin-6[J]. Am J Ophthalmol, 2005, 140(2): 256-261. DOI: 10.1016/j.ajo.2005.03.003.
2. Kuppermann BD, Blumenkranz MS, Haller JA, et al. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema[J]. Arch Ophthalmol, 2007, 125(3): 309-317. DOI: 10.1001/archopht.125.3.309.
3. Leopold IH. Nonsteroidal and steroidal anti-inflammatory agents[M]//Sears ML, Tarkkanen A. Surgical pharmacology of the eye. New York: Raven Press, 1985: 83-133.
4. Nauck M, Karakiulakis G, Perruchoud AP, et al. Corticosteroids inhibit the expression of the vascular endothelial growth factor gene in human vascular smooth muscle cells[J]. Eur J Pharmacol, 1998, 341(2-3): 309-315.
5. Haller JA, Bandello F, Belfort R, et al. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion[J]. Ophthalmology, 2010, 117(6): 1134-1146. DOI: 10.1016/j.ophtha.2010.03.032.
6. Li X, Wang N, Liang X, et al. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study[J]. Graefe's Arch Clin Exp Ophthalmol, 2018, 256(1): 59-69. DOI: 10.1007/s00417-017-3831-6.
7. Capone A, Singer MA, Dodwell DG, et al. Efficacy and safety of two or more dexamethasone intravitreal implant injections for treatment of macular edema related to retinal vein occlusion (SHASTA study)[J]. Retina, 2014, 34(2): 342-351. DOI: 10.1097/IAE.0b013e318297f842.
8. Matonti F, Meyer F, Guigou S, et al. Ozurdex in the management of the macular edema following retinal vein occlusion in clinical practice[J]. Acta Ophthalmol, 2013, 91(7): 584-586. DOI: 10.1111/aos.12190.
9. Pommier S, Meyer F, Guigou S, et al. Long-term real-life efficacy and safety of repeated Ozurdex injections and factors associated with macular edema resolution after retinal vein occlusion: the REMIDO 2 study[J]. Ophthalmologica, 2016, 236(4): 186-192. DOI: 10.1159/000452896.
10. Haller JA, Bandello F, Belfort R, et al. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results[J]. Ophthalmology, 2011, 118(12): 2453-2460. DOI: 10.1016/j.ophtha.2011.05.014.
11. Meyer LM, Schonfeld CL. Secondary glaucoma after intravitreal dexamethasone 0.7 mg implant in patients with retinal vein occlusion: a one-year follow-up[J]. J Ocul Pharmacol Ther, 2013, 29(6): 560-565. DOI: 10.1089/jop.2012.0253.
12. Coscas G, Augustin A, Bandello F, et al. Retreatment with Ozurdex for macular edema secondary to retinal vein occlusion[J]. Eur J Ophthalmol, 2013, 24(1): 1-9. DOI: 10.5301/ejo.5000376.
13. Ferrini W, Ambresin A. Intravitreal dexamethasone implant for the treatment of macular edema after retinal vein occlusion in a clinical setting[J]. Klin Monbl Augenheilkd, 2013, 230(4): 423-426. DOI: 10.1055/s-0032-1328388.
14. Chang-Lin JE, Attar M, Acheampong AA, et al. Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant[J]. Invest Ophthalmol Vis Sci, 2011, 52(1): 80-86. DOI: 10.1167/iovs.10-5285.
15. Ramezani A, Entezari M, Moradian S, et al. Intravitreal triamcinolone for acute central retinal vein occlusion: a randomized clinical trial[J]. Graefe’s Arch Clin Exp Ophthalmol, 2006, 244(12): 1601-1606. DOI: 10.1007/s00417-006-0348-9.
16. Ip MS, Gottlieb JL, Kahana A, et al. Intravitreal triamcinolone for the treatment of macular edema associated with central retinal vein occlusion[J]. Arch Ophthalmol, 2004, 122(8): 1131-1136. DOI: 10.1001/archopht.122.8.1131.
17. Malclès A, Dot C, Voirin N, Vié A L, et al. Safety of intravitreal dexamethasone implant (Ozurdex): The SAFODEX study[J]. Retina, 2017, 37(7): 1352-1359. DOI: 10.1097/IAE.0000000000001369.
18. Scott IU, Ip MS, VanVeldhuisen PC, et al. 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[J]. Arch Ophthalmol, 2009, 127(9): 1115-1128. DOI: 10.1001/archophthalmol.2009.233.
19. Gu X, Yu X, Song S, et al. Intravitreal dexamethasone implant versus intravitreal ranibizumab for the treatment of macular edema secondary to retinal vein occlusion in a Chinese population[J]. Ophthalmic Res, 2017, 58(1): 8-14. DOI: 10.1159/000458534.

Chinese Journal of Ocular Fundus Diseases

One year clinical observation of dexamethasone intravitreal implant (Ozurdex) in the treatment of macular edema secondary to retinal vein occlusion

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