Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg.
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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ABSTRACT: To evaluate secondary ocular hypertension after intravitreal injection of triamcinolone acetonide (IVTA) with 2 mg/0.05 mL or 4 mg/0.1 mL for macular edema associated with retinal vein occlusion (RVO). A retrospective chart review was performed. Patients with RVO, including central RVO and branch RVO, were divided into 2 groups. Group 1 was patients who received 2 mg IVTA and group 2 received 4 mg IVTA. The dose of IVTA was dependent on individual surgeon's decision. Secondary ocular hypertension was defined as intraocular pressure (IOP) >21 mmHg. Long-term antiglaucoma medication referred to eyes that required antiglaucoma agents for >6 months. Thirty-six eyes in group 1 and 32 eyes in group 2 were included in the analyses. The mean age of all the patients was 58.6 years, and 52.9% of patients were men. The mean follow-up period was 12.4 months. A wide range (from day 7 to month 8) of time until the onset of the IOP spike was recorded after the injection. The incidence of secondary ocular hypertension was not significantly different between group 2 and group 1 (38.9% vs. 50%, P = 0.36). However, group 2 had a higher proportion of long-term antiglaucoma medication usage than group 1 (5.6% vs. 40.6%; Pearson chi-square, P < 0.001). Ultimately, 2.9% of patients underwent filtration surgery. Macular edema diminished and best-corrected visual acuity improved at 3 months later in both groups. With a similar effect on vision recovery and alleviating macular edema associated with RVO, 2 mg IVTA required a shorter duration of medical control for secondary ocular hypertension than 4 mg IVTA.Journal of ocular pharmacology and therapeutics: the official journal of the Association for Ocular Pharmacology and Therapeutics 08/2010; 26(4):325-8. · 1.46 Impact Factor
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ABSTRACT: To compare the efficacy of a single injection of combined intravitreal dexamethasone and bevacizumab (Avastin) with that of intravitreal triamcinolone acetonide in eyes with diffuse cystoid diabetic macular oedema. Prospective, non-randomized, masked, interventional case series. Twenty-four eyes of 24 subjects with centre-involved diabetic macular oedema extending over two disc-areas with predominant cystic changes on spectral domain optical coherence tomography were selected. Ten phakic and two pseudophakic, ocular hypertensive eyes received intravitreal dexamethasone and bevacizumab as against 12 pseudophakic, normotensive eyes that received intravitreal triamcinolone acetonide. Change in central macular volume on spectral domain optical coherence tomography and best-corrected visual acuity were measured at 6-week follow-up. Baseline data were matched in both groups. Post-injection central macular volume (7.46 ± 0.73 mm(3)) was significantly lower (P < 0.001) in the intravitreal triamcinolone acetonide group when compared with its pre-injection central macular volume (9.11 ± 1.0 mm(3)) or when compared with the post-injection central macular volume (P = 0.02) of the intravitreal dexamethasone and bevacizumab group (8.42 ± 1.18 mm(3)). However, post-injection best-corrected visual acuity between the intravitreal triamcinolone acetonide (0.65 ± 0.15 logMAR) and the intravitreal dexamethasone and bevacizumab groups (0.685 ± 0.15 logMAR) was not significantly different (P = 0.06) at 6 weeks. No significant correlation was noted between change in central macular volume and change in best-corrected visual acuity (r = 0.35, P = 0.07) from the pooled data of both the groups. A fair correlation was noted between change in central macular volume and pre-injection central macular volume (r = 0.55, P = 0.005). Intravitreal triamcinolone acetonide may be more effective than intravitreal dexamethasone and bevacizumab in reducing macular volume in patients with diffuse cystoid diabetic macular oedema. A significant reduction in macular volume does not necessarily translate into a correspondingly significant improvement in best-corrected visual acuity.Clinical and Experimental Ophthalmology 09/2011; 39(7):673-81. · 1.96 Impact Factor
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ABSTRACT: To evaluate the efficacy of intravitreal injection of bevacizumab (IVB) followed by modified grid laser photocoagulation (MGP) versus each alone as a primary treatment of diffuse diabetic macular edema. A randomized 3-arm clinical trial in which 62 eyes of 48 patients with diffuse diabetic macular edema were enrolled. Eyes were randomly distributed to 1 of 3 study groups: 19 eyes underwent MGP (MGP group), 21 eyes received 1.25 mg of IVB (IVB group), and 22 eyes received IVB followed by MGP (combined group). All eyes underwent a complete ophthalmic examination including fluorescein angiography and optical coherence tomography at baseline and at 1, 3, and 6 months, after treatment. Fluorescein angiography was performed at the 3 and 6 months follow up visits. The outcome measures were the change compared with baseline in central macular thickness (CMT), changes in best-corrected visual acuity (BCVA), changes in fluorescein angiography leakage, and any reported complication. A P value less than 0.05 was considered statistically significant. One month after treatment, the reduction in the mean CMT versus baseline was 49.88 μm (10.45%) in MGP group, 150.92 μm (31.30%) in IVB group, and 110.30 μm (23.77%) in the combined group, with a corresponding improvement in the mean BCVA. At 1 month, the improvement in CMT was better than baseline in all groups, yet only significant in the IVB group (P < 0.05) and the combined group (P < 0.05). The improvement in mean BCVA was significant in the IVB (P < 0.05) and the combined groups at 1 month (P < 0.05). At 3 months, the mean CMT was still better than baseline in all groups but this improvement was significant only in the combined group (P < 0.05). The improvement in the mean BCVA was significant only in the IVB and the combined groups (P < 0.05). Six months after treatment, the reduction in the mean CMT was significant in the combined group only (P < 0.05) and there was no significant improvement in the mean BCVA in all groups (P > 0.05). The BCVA did not deteriorate below baseline in all eyes included in the study, except three eyes in the MGP group. No complication related to the intravitreal injection was reported in the injected eyes. Combined therapy with IVB and sequential MGP 3 weeks later appeared to be superior to MGP or IVB alone in reducing macular thickening and improving visual acuity. However, no significant improvement in BCVA occurs 6 months after treatment. A combination of IVB and sequential MGP could be used as an initial treatment of diffuse diabetic macular edema.Retina (Philadelphia, Pa.) 01/2010; 30(10):1638-45. · 2.93 Impact Factor