Intravitreal Triamcinolone Acetonide for Diffuse Diabetic Macular Edema: Phase 2 Trial Comparing 4 mg vs 2 mg

Department of Ophthalmology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Université Paris, Paris, France.
American Journal of Ophthalmology (Impact Factor: 3.87). 12/2006; 142(5):794-99. DOI: 10.1016/j.ajo.2006.06.011
Source: PubMed

ABSTRACT To prospectively compare the efficacy and safety of 4 vs 2 mg intravitreal triamcinolone acetonide (TA) injection for diabetic macular edema.
Interventional case series.

Thirty-two patients with diabetic macular edema unresponsive to laser photocoagulation.
Patients were randomly assigned to receive 4 or 2 mg intravitreal TA in one eye (16 patients in each group).
The main outcome was central macular thickness (CMT) measured by optical coherence tomography (OCT) at four, 12, and 24 weeks. Secondary outcomes were gain in Early Treatment Diabetic Retinopathy Study (ETDRS) scores, intraocular pressure (IOP), cataract progression, and duration of effect.
Before injection, mean (+/- SD) CMT was 564.5 +/- 119 microm and 522.9 +/- 148.5 microm in the 4- and 2-mg groups, respectively. At four, 12, and 24 weeks after injection, it was 275.0 +/- 79.8, 271.4 +/- 128.7, and 448.7 +/- 146.4 microm, respectively, in the 4-mg group, and 267.3 +/- 82.4, 289.8 +/- 111.4, and 394.7 +/- 178.9 microm, respectively, in the 2-mg group. At no time was the difference in CMT between both groups statistically significant (P> 0.3). The between-group differences in the gain in the ETDRS score and in IOP were not statistically significant either. Diabetic macular edema recurred after a median period of 20 weeks vs 16 weeks in the 4- and 2-mg groups, respectively (P = 0.11).
In the short term, intravitreal injection of 4 or 2 mg TA does not have different effects on CMT, visual acuity, or IOP.

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    • "sual acuity has been demonstrated but less effective than intravitreal . Intravitreal triamcinolone ( IVTA ) has shown significant improvements in diabetic macular edema and visual acuity in short term and it was found to be superior to sub - tenon injection ( Jonas , 2007 ; Gillies et al . , 2006 ; Massin et al . , 2004 ; Dehghan et al . , 2008 ; Audren et al . , 2006 ; Avitabile et al . , 2005 ; Wu et al . , 2008 ; Yil - maz et al . , 2009 ; Takata et al . , 2010 ) . The short term effect necessitates repeated intravitreal injections which was associ - ated with some complications including steroid - induced eleva - tion of intra - ocular pressure ( IOP ) , crystalline maculopathy and steroid - indu"
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    • "On the other hand has been demonstrated that the repetitious 4 mg triamcinolone injection can significantly reduce refractory diabetic macular oedema (Gillies et al. 2006; Jonas 2006) as does a sustained-release fluocinolone acetonide intravitreal implant (Elliot 2009). There have not been any clinical trial to select the optimal dosage or to calculate retreatment intervals , and the incidence of side-effects such as cataract induction or increase in intraocular pressure (IOP) are unsolved up to date (Krepler et al. 2005; Audren et al. 2006). "
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    ABSTRACT: This paper summarizes the recent evidence for combined therapies in the intravitreal medical treatment of diabetic macular oedema or macular oedema, secondary to retinal vein occlusion. Since the introduction of anti-inflammatory or anti-VEGF drugs combined with or used alternatively to laser, visual acuity can be stabilized or improved in a significant number of patients. However, there is an ongoing debate regarding the safety, efficiency and economic concerns related to these intravitreal monotherapies because they warrant frequent repetition to maintain the clinical effect. In the literature, the combination of photolasercoagulation, intravitreal steroids or VEGF-inhibitors, or both, shows early compelling evidence that some patients may benefit from less retreatment compared to monotherapy. To provide a conceptual and perspective approach for a first-line combined therapy, this paper also summarizes own results of pilot interventional case series of a 1.5 cc core pars plana vitrectomy and intravitreal substitution with balanced salt solution (BSS), 1.25 mg bevacizumab and 8 mg triamcinolone.
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    • "The actual dose of triamcinolone obtained by these techniques remains variable. It is also interesting to note that varying the concentration of triamcinolone does not necessarily increase the efficacy of the drug in diabetic macular oedema (Audren et al. 2006). "
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