Intravitreal steroids for macular edema in diabetes
- PMID: 18254088
- PMCID: PMC3804331
- DOI: 10.1002/14651858.CD005656.pub2
Intravitreal steroids for macular edema in diabetes
Update in
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Intravitreal steroids for macular edema in diabetes.Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3. Cochrane Database Syst Rev. 2020. PMID: 33206392 Free PMC article.
Abstract
Background: Macular edema is secondary to leakage from diseased retinal capillaries and is an important cause of poor central visual acuity in patients with diabetic retinopathy.
Objectives: This review evaluated the effectiveness and safety of intraocular steroids in treating diabetic macular edema (DME).
Search strategy: We searched CENTRAL, MEDLINE, EMBASE in June 2007, reference lists, Science Citation Index and conference proceedings.
Selection criteria: We included randomized clinical trials (RCTs) evaluating any form of intravitreal steroids for treating DME.
Data collection and analysis: Two authors independently assessed eligibility, methodological quality and extracted data. We performed meta-analyses when appropriate.
Main results: Seven studies, involving 632 DME eyes were included. Four examined the effectiveness of intravitreal triamcinolone acetate injection (IVTA), three examined intravitreal steroids implantation (fluocinolone acetonide implant (FAI) or dexamethasone drug delivery system (DDS)). Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias and the remaining two were at unclear risk of bias. The preponderance of data suggest a beneficial effect from IVTA. Comparing IVTA with controls, the mean difference in visual acuity was -0.15 LogMAR (95% CI -0.21 to -0.09) at 3 months (based on three trials), -0.23 LogMAR (95% CI -0.33 to -0.13) at 6 months (two trials), -0.29 LogMAR (95% CI -0.47 to -0.11) at 9 months (one trial), and -0.11 LogMAR (95% CI -0.20 to -0.03) at 24 months (one trial), all in favor of IVTA. The relative risk (RR) for one or more lines improvement in visual acuity was 2.85 (95% CI 1.59 to 5.10) at 3 months (two trials), 1.25 (95% CI 0.66 to 2.38) at 6 months (one trial), and 2.17 (95% CI 1.15 to 4.11) at 24 months (one trial), all in favor of IVTA. We did not find evidence for three or more lines improvement in visual acuity. The mean difference in retinal thickness was -131.97 um (95% CI -169.08 to -94.86) at 3 months (two trials), -135.00 um (95% CI -194.50 to -75.50) at 6 months (one trial), -133.00 um (95% CI -199.86 to -66.14) at 9 months (one trial), and -59.00 um (95% CI -103.50 to -14.50) at 24 months (one trial), all in favor of IVTA. The RR for at least one grade macular edema resolution was 5.15 (95% CI 2.23 to 11.88) at 3 months in favor of IVTA (one trial). Two trials reported improved clinical outcome when FAI was compared to standard of care. Beneficial effect was also observed in one dexamethasone DDS trial. Increased intraocular pressure and cataract formation were side effects requiring monitoring and management.
Authors' conclusions: RCTs included in this review suggest that steroids placed inside the eye by either intravitreal injection or surgical implantation may improve visual outcomes in eyes with persistent or refractory DME. Since the studies in our report focused on chronic or refractory DME, the question arises whether intravitreal steroids therapy could be of value in other stages of DME, especially the earlier stages either as standalone therapy or in combination with other therapies, such as laser photocoagulation.
References
References to studies
Included studies
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Audren 2006 Published and unpublished data Audren F, Erginay A, Haouchine B, Benosman R, Conrath J, Bergmann JF, et al. Intravitreal triamcinolone acetonide for diffuse diabetic macular oedema: 6-month results of a prospective controlled trial. Acta ophthalmologica Scandinavica. 2006;84(5):624–630. Massin P, Audren F, Haouchine B, Erginay A, Bergmann JF, Benosman R, et al. Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial. Ophthalmology. 2004;111(2):218–224.
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Avitabile 2005 Avitabile T, Longo A, Reibaldi A. Intravitreal triamcinolone compared with macular laser grid photocoagulation for the treatment of cystoid macular edema. American Journal of Ophthalmology. 2005;140(4):695–702.
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Jonas 2006 Jonas JB, Kampperter BA, Harder B, Vossmerbaeumer U, Sauder G, Spandau UH. Intravitreal triamcinolone acetonide for diabetic macular edema: a prospective, randomized study. Journal of Ocular Pharmacology & Therapeutics. 2006;22(3):200–207.
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Kuppermann 2007 Unpublished data only Kuppermann BD, Blumenkranz MS, Haller JA, Williams GA Posurdex Study Group. An Intravitreous Dexamethasone Bioerodible Drug Delivery System for the Treatment of Persistent Diabetic Macular Edema; Association for Research in Vision and Ophthalmology Annual Meeting; 2003. Kuppermann BD, Blumenkranz MS, Haller JA, Williams GA, Weinberg DV, Chou C, et al. Randomized Controlled Study of an Intravitreous Dexamethasone Drug Delivery System in Patients With Persistent Macular Edema. Archives of Ophthalmology. 2007;125(3):309–317.
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Pearson 2002 Unpublished data only Nancy Groves, Reviewed by Pearson PA. Steroids implant reduces retinal thickness, improves vision. Ophthalmology Times. 2004 Nov 15;:24–26. Pearson PA, Baker CW, Eliott D, Ip MS, Morese LS, Callanan DG. Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema: 2 Year Results. Association for Research in Vision and Ophthalmology Annual Meeting. 2004 Pearson PA, Baker CW, Eliott D, Ip MS, Morese LS, Callanan DG. Fluocinolone Acetonide Intravitreal Implant in Patients with Diabetic Macular Edema; American Academy of Ophthalmology Annual Meeting; 2002. Pearson PA, Eliott D, Baker CW, Ip MS, Morese LS, Callanan DG. Fluocinolone Acetonide Intravitreal Implant in Patients with Diabetic Macular Edema; Association for Research in Vision and Ophthalmology Annual Meeting; 2003.
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Excluded studies
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Bandello 2004 Unpublished data only Bandello F, Polito A, Dimastrogiovanni A, Palsslos I. Intravitreal triamcinolone associated with grid laser photocoagulation for diffuse diabetic macular edema; Macular Society Annual Meeting; 2004.
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Bonini-Filho 2005 Bonini-Filho MA, Jorge R, Barbosa JC, Calucci D, Cardillo JA, Costa RA. Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: a randomized clinical tiral. Investigative Ophthalmology & Visual Science. 2005;46(10):3845–3849.
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Cardillo 2005 Cardillo JA, Melo LA, Jr, Costa RA, et al. Comparison of intravitreal versus posterior sub-Tenon's capsule injection of triamcinolone acetonide for diffuse diabetic macular edema. Ophthalmology. 2005;112(9):1157–1163.
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Er 2005 Er H, Yilmaz H. Intravitreal cortisone injection for refractory diffuse diabetic macular edema. Ophthalmologica. 2005;219(6):394–400.
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Jonas 2004 Jonas JB, Harder B, Kamppeter BA. Inter-eye difference in diabetic macular edema after unilateral intravitreal injection of triamcinolone acetonide. American Journal of Ophthalmology. 2004;138(6):970–977.
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Studies awaiting classification
Ongoing studies
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Ip 2004 Unpublished data only
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Other references
Additional references
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Aroca 2004 Aroca PR, Salvat M, Fernandez J, Mendez I. Risk factors for diffuse and focal macular edema. Journal of Diabetes Complications. 2004;18(4):211–215.
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CDCP 1996 Centers for Disease Control and Prevention. Blindness caused by diabetes: Massachusetts, 1987–1994. Morbidity and Mortality Weekly Report. 1996;45(43):937–941.
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Ciulla 2004 Ciulla TA, Walker JD, Fong DS, Criswell MH. Corticosteroids in posterior segment disease: an update on new delivery systems and new indications. Current Opinions in Ophthalmology. 2004;15(3):211–220.
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Cunha-Vaz 1998 Cunha-Vaz J. Diabetic macular edema. European Journal of Ophthalmology. 1998;8:127–130.
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DCCT 1993 The Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New England Journal of Medicine. 1993;329:977–986.
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