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International Ophthalmology

, Volume 28, Issue 1, pp 7–17 | Cite as

A randomized, placebo-controlled clinical trial of intravitreal triamcinolone for refractory diabetic macular edema

  • Mohammad H. Dehghan
  • Hamid Ahmadieh
  • Alireza Ramezani
  • Morteza Entezari
  • Arash Anisian
Original paper

Abstract

Purpose To evaluate the effect of intravitreal triamcinolone acetonide (IVT) on refractory diabetic macular edema (DME). Methods In a prospective, placebo-controlled, randomized clinical trial, 88 eyes of 61 patients with clinically significant macular edema that would have responded unfavourably to laser photocoagulation were randomly assigned to two groups. The treatment group (45 eyes) received 4 mg IVT and the control group (43 eyes) received a placebo subconjunctival injection. The primary outcome was central macular thickness (CMT) measured by optical coherence tomography. Complete examination was repeated at 2 and 4 months post-intervention. Results The mean (SD) CMT before the intervention and at the 2- and 4-month follow-ups was 393 (151), 293 (109) and 362 (119) μm in the treatment group and 393 (166), 404 (134) and 405 (160) μm in the placebo group, respectively. The second month difference was significant (P = 0.01). The difference between visual acuity changes (0.15 logarithm of the minimum angle of resolution, logMAR) was significant at 2 months (P = 0.02) but reduced to 0.11 logMAR (P = 0.08) after 4 months. Reduction for hard exudates and petaloid pattern were significantly greater in cases at 4 months. Conclusions The therapeutic effect of IVT on DME is greatest at 2 months and decreases up to the fourth month post-intervention. However, in terms of cystoid macular edema and hard exudates, the effect is maintained up to 4 months.

Keywords

Cystoid macular edema Diabetic macular edema Hard exudates Intravitreal triamcinolone Macular thickness 

Abbreviations

BUN

Blood urea nitrogen

CME

Cystoid macular edema

CMT

Central macular thickness

CSME

Clinically significant macular edema

DME

Diabetic macular edema

ETDRS

Early treatment diabetic retinopathy study

FBS

Fasting blood sugar

HE

Hard exudates

IOP

Intraocular pressure

LogMAR

Logarithm of the minimum angle of resolution

MPC

Macular photocoagulation

NVI

Neovascularization of iris

OCT

Optical coherence tomography

PRP

Panretinal photocoagulation

VA

Visual acuity

Notes

Acknowledgements

This study was supported by the Ophthalmic Research Centre of Shaheed Beheshti Medical University.

References

  1. 1.
    Ferris FL III, Patz A (1984) Macular edema. A complication of diabetic retinopathy. Surv Ophthalmol 28[Suppl]:S452–S461CrossRefGoogle Scholar
  2. 2.
    Early Treatment Diabetic Retinopathy Study Research Group (1985) Photocoagulation for diabetic macular edema: early treatment diabetic retinopathy study report number 1. Arch Ophthalmol 103:1796–1806Google Scholar
  3. 3.
    Early Treatment Diabetic Retinopathy Study Research Group (1987) Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema: early treatment diabetic retinopathy study report number 2. Ophthalmology 94:761–774Google Scholar
  4. 4.
    Olk RJ (1989) Diabetic retinopathy. In: Yannuzzi LA (ed) Laser photocoagulation of the macula. JB Lippincott, PhiladelphiaGoogle Scholar
  5. 5.
    McMeel JW, Trempe CL, Franks EB (1977) Diabetic maculopathy. Trans Am Acad Ophthalmol Otolaryngol 83:476–487Google Scholar
  6. 6.
    Early Treatment Diabetic Retinopathy Study Research Group (1995) Focal photocoagulation treatment of diabetic macular edema. Relationship of treatment effect to fluorescein angiographic and other retinal characteristics at baseline: ETDRS report No. 19. Arch Ophthalmol 113:1144–1155Google Scholar
  7. 7.
    Cantrill HL (1984) The diabetic retinopathy study and the early treatment diabetic retinopathy study. Int Ophthalmol Clin 24:13–29PubMedCrossRefGoogle Scholar
  8. 8.
    Gardner TW, Antonetti DA, Barber AJ, LaNoue KF, Levison SW, Penn State Retina Research Group (2002) Diabetic retinopathy: more than meets the eye. Surv Ophthalmol 47(suppl 2):S253–S256PubMedCrossRefGoogle Scholar
  9. 9.
    Bakri SJ, Kaiser PK (2005) Posterior subtenon triamcinolone acetonide for refractory diabetic macular edema. Am J Ophthalmol 139:290–294PubMedCrossRefGoogle Scholar
  10. 10.
    Jonas JB, Sofker A (2001) Intraocular injection of crystalline cortisone as adjunctive treatment of diabetic macular edema. Am J Ophthalmol 132:425–427PubMedCrossRefGoogle Scholar
  11. 11.
    Martidis A, Duker JS, Greenberg PB et al. (2002) Intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology 109:920–926PubMedCrossRefGoogle Scholar
  12. 12.
    Jonas JB, Kreissig I, Sofker A, Degenring RF (2003) Intravitreal injection of triamcinolone for diffuse diabetic macular edema. Arch Ophthalmol 121:57–61PubMedCrossRefGoogle Scholar
  13. 13.
    Tan DT, Chee SP, Lim L, Lim AS (1999) Randomized clinical trial of a new dexamethasone delivery system (Surodex) for treatment of post-cataract surgery inflammation. Ophthalmology 106:223–231PubMedCrossRefGoogle Scholar
  14. 14.
    Beer PM, Bakri SJ (2003) Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection. Ophthalmology 110:681–686PubMedCrossRefGoogle Scholar
  15. 15.
    Nelson ML, Tentant MTS (2003) Infectious and presumed noninfectious endophthalmitis after intravitreal triamcinolone acetonide injection. Retina 23:686–691PubMedCrossRefGoogle Scholar
  16. 16.
    Rodriguez-Coleman H, Yuan P, Kim H, Gravlin L, Srivastava S, Csaky KG, Robinson MR (2004) Intravitreal injection of triamcinlone for diffuse macular edema. Arch Ophthalmol 122:1085–1086Google Scholar
  17. 17.
    Jonas JB, Kreissig I, Degenring R (2003) Intraocular pressure after injection of triamcinolone acetonide. Br J Ophthalmol 87:24–27PubMedCrossRefGoogle Scholar
  18. 18.
    Danis RP, Ciulla TA, Pratt LM, Anliker W (2000) Intravitreal triamcinolone acetonide in exudative age-related macular degeneration. Retina 20:244–250PubMedCrossRefGoogle Scholar
  19. 19.
    Ciardella AP, Klancnik J, Schiff W, Barile G, Langton K, Chang S (2004) Intravitreal triamcinolone for the treatment of refractory diabetic macular oedema with hard exudates: an optical coherence tomography study. Br J Ophthalmol 88:1131–1136Google Scholar
  20. 20.
    Sutter FK, Simpson JM, Gillies MC (2004) Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment: three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial. Ophthalmology 111:2044–2049PubMedCrossRefGoogle Scholar
  21. 21.
    Massin P, Audren F, Haouchine B et al (2004) Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial. Ophthalmology 111:218–224PubMedCrossRefGoogle Scholar
  22. 22.
    Goebel W, Kretzchmar-Gross T (2002) Retinal thickness in diabetic retinopathy. Retina 22:759–767PubMedCrossRefGoogle Scholar
  23. 23.
    Otani T, Kishi S (2001) Tomographic findings of foveal hard exudates in diabetic macular edema. Am J Ophthalmol 131:50–54PubMedCrossRefGoogle Scholar
  24. 24.
    Nussenblatt RB, Kaufman SC, Palestin AG (1987) Macular thickening and visual acuity. Measurements in patients with cystoid macular edema. Ophthalmology 94:1134–1139PubMedGoogle Scholar
  25. 25.
    Yasukawa I, Kiryu J, Tsujikawa A, Dong J, Suzuma I, Takagi H, Ogura Y (1998) Quantitative analysis of foveal retinal thickness in diabetic retinopathy with the scanning retinal thickness analyzer. Retina 18:150–155Google Scholar
  26. 26.
    Shahidi M, Ogura Y, Blair NP (1991) Retinal thickness analysis for quantitative assessment of diabetic macular edema. Arch Ophthalmol 109:1115–1120PubMedGoogle Scholar
  27. 27.
    Jonas JB, Kreissig I, Degenring RF (2003) Intravitreal triamcinolone acetonide for pseudophakic cystoid macular edema. Am J Ophthalmol 136:384–386PubMedCrossRefGoogle Scholar
  28. 28.
    Conway MD, Canakis C, Livir-Rallatos C, Peyman GA (2003) Intravitreal triamcinolone acetonide for refractory chronic pseudophakic cystoid macular edema. J Cataract Refract Surg 291:27–33CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media B.V. 2007

Authors and Affiliations

  • Mohammad H. Dehghan
    • 1
  • Hamid Ahmadieh
    • 1
  • Alireza Ramezani
    • 1
  • Morteza Entezari
    • 1
  • Arash Anisian
    • 1
  1. 1.Ophthalmic Research Centre of Shaheed Beheshti Medical University, Labbafinejad Medical CentreTehranIran

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