OBJECTIVE: To compare the safety and efficacy of different doses of intravitreal triamcinolone (ivTA) in treating clinically significant diabetic macular oedema (CSMO). METHODS:63 eyes of 63 patients with CSMO and central foveal thickness (CFT) of > or =250 microm on optical coherence tomography were randomised to receive 4 mg (n = 23), 6 mg (n = 20) or 8 mg (n = 20) ivTA. Patients were followed up for 6 months, and changes in best-corrected visual acuity (BCVA), optical coherence tomography CFT, standardised change in macular thickness (SCMT), and side effects such as intraocular pressure and cataractogenesis were compared between the three groups. RESULTS: After ivTA injection, improvements of BCVA and CFT occurred in all groups. The mean BCVA improvement at 6 months was significantly higher for the 8 mg group compared with the 4 mg group, with 9.9 and 3.1 improvement in letters on the Early Treatment of Diabetic Retinopathy Study chart, respectively (p = 0.047). The mean SCMT at 6 months for the 4, 6 and 8 mg groups was 28.7%, 42.3% and 60.5%, respectively (p = 0.06). The proportion of eyes with SCMT > or =75% at 6 months was higher in the 8 mg group, but the difference failed to reach significance (p = 0.06). Ocular hypertensive responses (>21 mm Hg) occurred in 39%, 30% and 55% of eyes in the 4, 6, and 8 mg groups, respectively (p = 0.27). CONCLUSIONS: Higher doses of ivTA may prolong the duration of visual benefit in diabetic CSMO and seemed to result in more sustained reduction in macular oedema. Further studies are warranted to investigate the optimum dose of ivTA in treating diabetic CSMO.
RCT Entities:
OBJECTIVE: To compare the safety and efficacy of different doses of intravitreal triamcinolone (ivTA) in treating clinically significant diabetic macular oedema (CSMO). METHODS: 63 eyes of 63 patients with CSMO and central foveal thickness (CFT) of > or =250 microm on optical coherence tomography were randomised to receive 4 mg (n = 23), 6 mg (n = 20) or 8 mg (n = 20) ivTA. Patients were followed up for 6 months, and changes in best-corrected visual acuity (BCVA), optical coherence tomography CFT, standardised change in macular thickness (SCMT), and side effects such as intraocular pressure and cataractogenesis were compared between the three groups. RESULTS: After ivTA injection, improvements of BCVA and CFT occurred in all groups. The mean BCVA improvement at 6 months was significantly higher for the 8 mg group compared with the 4 mg group, with 9.9 and 3.1 improvement in letters on the Early Treatment of Diabetic Retinopathy Study chart, respectively (p = 0.047). The mean SCMT at 6 months for the 4, 6 and 8 mg groups was 28.7%, 42.3% and 60.5%, respectively (p = 0.06). The proportion of eyes with SCMT > or =75% at 6 months was higher in the 8 mg group, but the difference failed to reach significance (p = 0.06). Ocular hypertensive responses (>21 mm Hg) occurred in 39%, 30% and 55% of eyes in the 4, 6, and 8 mg groups, respectively (p = 0.27). CONCLUSIONS: Higher doses of ivTA may prolong the duration of visual benefit in diabetic CSMO and seemed to result in more sustained reduction in macular oedema. Further studies are warranted to investigate the optimum dose of ivTA in treating diabetic CSMO.
Authors: Dennis S C Lam; Carmen K M Chan; Emily W H Tang; Kenneth K W Li; Dorothy S P Fan; Wai-Man Chan Journal: Clin Exp Ophthalmol Date: 2004-12 Impact factor: 4.207