Safety and long-term efficacy of repeated dexamethasone intravitreal implants for the treatment of cystoid macular edema secondary to retinal vein occlusion with or without a switch to anti-VEGF agents: a 3-year experience
To evaluate the safety and efficacy of repeated dexamethasone intravitreal implants (DEX implants) over 3 years in eyes with macular edema (ME) secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
We conducted a 3-year, retrospective, multicenter study that included adult patients with ME secondary to BRVO or CRVO treated with first-line DEX implants. Patients were divided into two different subgroups: patients who received DEX implant injections only (group 1) and those who received DEX implants first and then were switched to anti-VEGF agents (group 2). Primary endpoints were changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to month 6 and month 36. Secondary endpoints included changes in both BCVA and CRT after each DEX implant and adverse events, particularly cataract extraction and elevated intraocular pressure (IOP).
Sixty-six patients with a median [IQR (interquartile ratio)] age of 72 [65.0; 81.1] years were included (40.9% BRVO, 59.1% CRVO), who received a median of 5.0 [min, 1.0; max, 10.0] DEX implants over 3 years. Median [IQR] time to retreatment was 4.8 [4.2; 6.0] months. The median [IQR] improvements in BCVA from baseline until months 6 and 36 were respectively + 10.0 [0; + 20.0] letters (P = 0.040) and + 10.0 [− 8.7; + 20.0] letters (P = 0.364) in the whole population. In group 1, the results were similar, whereas in group 2, BCVA significantly increased at M36 compared with baseline (P = 0.003). The median [IQR] CRT reductions from baseline to months 6 and 36 were respectively − 227.5 [− 337.0; − 52.7] μm and − 224.0 [− 405.0; − 83.8] μm (P < 0.001) in the whole population. Results were similar in both groups. The most common adverse events were cataract extraction (70.4%) and elevated IOP (54.5%). No other serious local complications were observed. Treatment was switched to anti-VEGF agents in 16 (24.2%) patients.
DEX implants are an effective treatment for BRVO and CRVO-associated ME over 3 years. It is a valid treatment even though complications remain frequent. However, functional efficacy seems to decrease with time and repeated injections.
KeywordsDexamethasone Intravitreal injection Retinal vein occlusion Macular edema
The authors gratefully thank Apolline Mairot for her collaboration and her assistance in collecting data.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (place name of institute/committee) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
For this type of study, formal consent is not required.
- 3.Rogers S, McIntosh RL, Cheung N, Lim L, Wang JJ, Mitchell P, Kowalski JW, Nguyen H, Wong TY, International Eye Disease C (2010) The prevalence of retinal vein occlusion: pooled data from population studies from the United States, Europe, Asia, and Australia. Ophthalmology 117:313–319 e311. https://doi.org/10.1016/j.ophtha.2009.07.017 CrossRefPubMedPubMedCentralGoogle Scholar
- 8.(1997) Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol 115:486–491Google Scholar
- 9.Ehlers JP, Kim SJ, Yeh S, Thorne JE, Mruthyunjaya P, Schoenberger SD, Bakri SJ (2017) Therapies for macular edema associated with branch retinal vein occlusion: a report by the American Academy of Ophthalmology. Ophthalmology 124:1412–1423. https://doi.org/10.1016/j.ophtha.2017.03.060 CrossRefPubMedGoogle Scholar
- 10.Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM, Group OGS (2010) Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology 117:1134–1146 e1133. https://doi.org/10.1016/j.ophtha.2010.03.032 CrossRefPubMedGoogle Scholar
- 11.Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jiao J, Li XY, Whitcup SM, Ozurdex GSG, Li J (2011) Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results. Ophthalmology 118:2453–2460. https://doi.org/10.1016/j.ophtha.2011.05.014 CrossRefPubMedGoogle Scholar
- 12.SF0 Intravitreal Injection. French Society of Ophthalmology http://www.sfo.asso.fr/files/files//FICHE-INFO-PATIENT_/Fiche_65_Injection_intravitreenne_18janv16(1).pdf: Accessed 19 Feb2018
- 13.Korobelnik JF, Kodjikian L, Delcourt C, Gualino V, Leaback R, Pinchinat S, Velard ME (2016) Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. Graefes Arch Clin Exp Ophthalmol 254:2307–2318. https://doi.org/10.1007/s00417-016-3394-y CrossRefPubMedPubMedCentralGoogle Scholar
- 15.Bezatis A, Spital G, Hohn F, Maier M, Clemens CR, Wachtlin J, Lehmann F, Hattenbach LO, Feltgen N, Meyer CH (2013) Functional and anatomical results after a single intravitreal Ozurdex injection in retinal vein occlusion: a 6-month follow-up—the SOLO study. Acta Ophthalmol 91:e340–e347. https://doi.org/10.1111/aos.12020 CrossRefPubMedGoogle Scholar
- 17.Hoerauf H, Feltgen N, Weiss C, Paulus EM, Schmitz-Valckenberg S, Pielen A, Puri P, Berk H, Eter N, Wiedemann P, Lang GE, Rehak M, Wolf A, Bertelmann T, Hattenbach LO, Group C-CS (2016) Clinical efficacy and safety of Ranibizumab versus dexamethasone for central retinal vein occlusion (COMRADE C): a European label study. Am J Ophthalmol 169:258–267. https://doi.org/10.1016/j.ajo.2016.04.020 CrossRefPubMedGoogle Scholar
- 18.Pommier S, Meyer F, Guigou S, Barthelemy T, Gobert F, Hajjar C, Merite PY, Parrat E, Rouhette H, Matonti F (2016) Long-term real-life efficacy and safety of repeated Ozurdex(R) injections and factors associated with macular edema resolution after retinal vein occlusion: the REMIDO 2 study. Ophthalmologica 236:186–192. https://doi.org/10.1159/000452896 CrossRefPubMedGoogle Scholar
- 21.Capone A Jr, Singer MA, Dodwell DG, Dreyer RF, Oh KT, Roth DB, Walt JG, Scott LC, Hollander DA (2014) Efficacy and safety of two or more dexamethasone intravitreal implant injections for treatment of macular edema related to retinal vein occlusion (Shasta study). Retina 34:342–351. https://doi.org/10.1097/IAE.0b013e318297f842 CrossRefPubMedGoogle Scholar
- 24.Pielen A, Buhler AD, Heinzelmann SU, Bohringer D, Ness T, Junker B (2017) Switch of intravitreal therapy for macular edema secondary to retinal vein occlusion from anti-VEGF to dexamethasone implant and vice versa. J Ophthalmol 2017:5831682. https://doi.org/10.1155/2017/5831682 CrossRefPubMedPubMedCentralGoogle Scholar
- 26.Bandello F, Parravano M, Cavallero E, Cascavilla ML, Triolo G, Querques L, Borrelli E, Giorno P, Varano M, Lattanzio R, Querques G (2015) Prospective evaluation of morphological and functional changes after repeated intravitreal dexamethasone implant (Ozurdex(R)) for retinal vein occlusion. Ophthalmic Res 53:207–216. https://doi.org/10.1159/000381187 CrossRefPubMedGoogle Scholar
- 28.Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y, China Ozurdex in RVOSG (2018) 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. Graefes Arch Clin Exp Ophthalmol 256:59–69. https://doi.org/10.1007/s00417-017-3831-6 CrossRefPubMedGoogle Scholar