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Five-year results of a randomized trial with open-label extension of triamcinolone acetonide for refractory diabetic macular edema


Gillies, M C; Simpson, J M; Gaston, C; Hunt, G; Ali, H; Zhu, M; Sutter, F (2009). Five-year results of a randomized trial with open-label extension of triamcinolone acetonide for refractory diabetic macular edema. Ophthalmology, 116(11):2182-2187.

Abstract

OBJECTIVE: To report 5-year outcomes from a clinical trial of intravitreal triamcinolone acetonide (IVTA) in eyes with diabetic macular edema (DME) and impaired vision despite previous laser treatment. DESIGN: Prospective, double-masked, randomized clinical trial. After completing the 2-year visit, all eyes, including those initially randomized to receive placebo, received IVTA according to prospectively defined guidelines. PARTICIPANTS AND CONTROLS: A total of 69 eyes (41 patients) were entered into the study, with 34 eyes initially receiving active treatment and 35 eyes receiving placebo. Five-year data were available for 44 of 67 eyes (66%). For the 23 eyes with missing 5-year data, of which 13 received placebo and 10 received IVTA, the last observation was carried forward. INTERVENTION: Intravitreal injection of 0.1 ml of 40 mg/ml triamcinolone acetonide with adjunctive laser therapy where appropriate. MAIN OUTCOME MEASURES: Improvement of best-corrected logarithm of the minimum angle of resolution visual acuity by >or=5 letters after 5 years compared with baseline and 2 years, and incidence of adverse events. Secondary outcome was the change in central macular thickness. RESULTS: Improvement of >or=5 letters after 5 years was found in 14 of 33 eyes (42%) initially treated with IVTA compared with 11 of 34 eyes (32%) initially treated with placebo (z(GEE) = 0.81, P = 0.4). Foveal thickness decreased by 30 microm (95% confidence interval, -47 to 107 microm) less in the initial-IVTA group than in the initial-placebo group at 5 years (z(GEE) = 0.76, P = 0.45); 5 of 11 eyes (45%) from the initial-IVTA group that were phakic at commencement of the third year required cataract surgery. A similar number of eyes from each group required ongoing treatment from the third year onward with both laser and IVTA, indicating that IVTA treatment for 2 years does not lead to reduction in the risk of recurrent edema. CONCLUSIONS: The majority of eyes that initially improved with IVTA maintained their gain after 5 years. No new safety concerns were identified. IVTA treatment may be considered in carefully selected cases of impaired vision caused by advanced DME that are unresponsive to other interventions.

Abstract

OBJECTIVE: To report 5-year outcomes from a clinical trial of intravitreal triamcinolone acetonide (IVTA) in eyes with diabetic macular edema (DME) and impaired vision despite previous laser treatment. DESIGN: Prospective, double-masked, randomized clinical trial. After completing the 2-year visit, all eyes, including those initially randomized to receive placebo, received IVTA according to prospectively defined guidelines. PARTICIPANTS AND CONTROLS: A total of 69 eyes (41 patients) were entered into the study, with 34 eyes initially receiving active treatment and 35 eyes receiving placebo. Five-year data were available for 44 of 67 eyes (66%). For the 23 eyes with missing 5-year data, of which 13 received placebo and 10 received IVTA, the last observation was carried forward. INTERVENTION: Intravitreal injection of 0.1 ml of 40 mg/ml triamcinolone acetonide with adjunctive laser therapy where appropriate. MAIN OUTCOME MEASURES: Improvement of best-corrected logarithm of the minimum angle of resolution visual acuity by >or=5 letters after 5 years compared with baseline and 2 years, and incidence of adverse events. Secondary outcome was the change in central macular thickness. RESULTS: Improvement of >or=5 letters after 5 years was found in 14 of 33 eyes (42%) initially treated with IVTA compared with 11 of 34 eyes (32%) initially treated with placebo (z(GEE) = 0.81, P = 0.4). Foveal thickness decreased by 30 microm (95% confidence interval, -47 to 107 microm) less in the initial-IVTA group than in the initial-placebo group at 5 years (z(GEE) = 0.76, P = 0.45); 5 of 11 eyes (45%) from the initial-IVTA group that were phakic at commencement of the third year required cataract surgery. A similar number of eyes from each group required ongoing treatment from the third year onward with both laser and IVTA, indicating that IVTA treatment for 2 years does not lead to reduction in the risk of recurrent edema. CONCLUSIONS: The majority of eyes that initially improved with IVTA maintained their gain after 5 years. No new safety concerns were identified. IVTA treatment may be considered in carefully selected cases of impaired vision caused by advanced DME that are unresponsive to other interventions.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Ophthalmology Clinic
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2009
Deposited On:28 Feb 2010 12:44
Last Modified:05 Apr 2016 13:58
Publisher:Elsevier
ISSN:0161-6420
Publisher DOI:https://doi.org/10.1016/j.ophtha.2009.04.049
PubMed ID:19796823

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