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• W4244341808 abstract "While most accept that intravitreal injections of triamcinolone acetonide (IVTA) can be efficacious for advanced diabetic macular edema (DME),1Sutter F.K. Simpson J.M. Gillies M.C. 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. 2004; 111: 2044-2049Abstract Full Text Full Text PDF PubMed Scopus (209) Google Scholar, 2Jonas J.B. Söfker A. Intraocular injection of crystalline cortisone as adjunctive treatment of diabetic macular edema.Am J Ophthalmol. 2001; 132: 425-427Abstract Full Text Full Text PDF PubMed Scopus (392) Google Scholar, 3Massin P. Audren F. Haouchine B. et al.Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial.Ophthalmology. 2004; 111: 218-224Abstract Full Text Full Text PDF PubMed Scopus (391) Google Scholar it is less certain whether they are safe and efficacious for more extended periods. Another unanswered question is whether the duration of macular edema at the time of treatment affects the anatomical and functional response.We have conducted a randomized, double-masked, placebo-controlled clinical trial of IVTA for DME in which all eyes also received laser treatment according to prospectively defined rules.1Sutter F.K. Simpson J.M. Gillies M.C. 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. 2004; 111: 2044-2049Abstract Full Text Full Text PDF PubMed Scopus (209) Google Scholar, 4Gillies M.C. Sutter F.K. Simpson J.M. et al.Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial.Ophthalmology. 2006; 113: 1533-1538Abstract Full Text Full Text PDF PubMed Scopus (368) Google Scholar After 2 years, there was a significant improvement in best-corrected logMAR visual acuity and central macular thickness (CMT). In order to study whether the patients who had initially received placebo treatment might still do as well as those who received IVTA, the trial became open label from 2 years. All eyes, including those that originally received placebo treatment, received IVTA according to prospectively defined guidelines. We present the third year results of the study, including the first 3-year safety data from a prospectively defined cohort.Eligibility criteria, procedures, and statistical methods for this trial have been previously described.3Massin P. Audren F. Haouchine B. et al.Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial.Ophthalmology. 2004; 111: 218-224Abstract Full Text Full Text PDF PubMed Scopus (391) Google Scholar, 4Gillies M.C. Sutter F.K. Simpson J.M. et al.Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial.Ophthalmology. 2006; 113: 1533-1538Abstract Full Text Full Text PDF PubMed Scopus (368) Google ScholarSixty-nine eyes of 43 patients were entered into the study, with 34 eyes randomized to receive active treatment, and 35 were given placebo. Three-year data were available for 48/69 (70%) eyes of 29/43 (67%) patients; 21 eyes of 14 patients were lost to follow-up, of which 10 had initially received placebo and 11 had initially received IVTA. For the eyes with missing 3-year data, the last observation was carried forward.A greater proportion of eyes from the initial IVTA group, 16/33 (48%), had an improvement in the primary outcome, gain of 5 or more letters from baseline, than from the group that initially received placebo 9/34 (26%), but this difference was of borderline significance (zGEE = 1.74, P = 0.08). Only 5/33 (15%) initial IVTA eyes lost 10 or more letters compared with 10/34 (29%) initial placebo eyes. In contrast to the apparent persistent difference in visual acuity results between the 2 groups, CMT had decreased the same amount at 3 years for the initial IVTA group (133 μm) as for the initial placebo group (130 μm). During the third year of the study, a similar proportion of eyes from the 2 groups had macular edema that warranted laser treatment: initial IVTA, 12/29 (41%); initial placebo, 10/28 (36%).Having peaked in the second year, the incidence of cataract surgery declined, with 2/11 (18%) eyes from the initial-IVTA group that were phakic at the beginning of the third year requiring cataract surgery. It was reassuring that no other serious adverse events were observed.We found that the initial beneficial effect of treatment continued to hold up more or less with respect to the primary outcome, with 48% of initial-IVTA eyes gaining 5 or more letters since baseline compared with 56% after 2 years.4Gillies M.C. Sutter F.K. Simpson J.M. et al.Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial.Ophthalmology. 2006; 113: 1533-1538Abstract Full Text Full Text PDF PubMed Scopus (368) Google Scholar A higher proportion, however, had lost 5 or more letters after 3 years than at 2 years (30% vs. 18%). Eyes that initially received IVTA still seemed to have better visual acuity outcomes after 3 years than eyes that had initially received placebo, although there was no difference in mean CMT between the 2 groups. To a certain extent, this may have been caused by spontaneous improvement in the initial placebo group that was seen at 2 years, but these eyes were eligible to receive intravitreal triamcinolone in the third year if they had persistent edema with impaired vision. Thus, judging by the equal requirement for laser by the 2 groups in the third year, treatment with IVTA did not lead to faster or more complete “drug-free” resolution of DME, but it may have limited irreversible damage that may have occurred in the group in which treatment was delayed.IVTA should not be given lightly. A recent, large, randomized, clinical trial established that laser is superior to IVTA as a first-line treatment for DME.5Diabetic Retinopathy Clinical Research NetworkA randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema.Ophthalmology. 2008; 115: 1447-1459Abstract Full Text Full Text PDF PubMed Scopus (525) Google Scholar In carefully selected cases, however, for example eyes that have failed laser treatment, we believe that IVTA still has a valuable role in preventing loss of vision. While most accept that intravitreal injections of triamcinolone acetonide (IVTA) can be efficacious for advanced diabetic macular edema (DME),1Sutter F.K. Simpson J.M. Gillies M.C. 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. 2004; 111: 2044-2049Abstract Full Text Full Text PDF PubMed Scopus (209) Google Scholar, 2Jonas J.B. Söfker A. Intraocular injection of crystalline cortisone as adjunctive treatment of diabetic macular edema.Am J Ophthalmol. 2001; 132: 425-427Abstract Full Text Full Text PDF PubMed Scopus (392) Google Scholar, 3Massin P. Audren F. Haouchine B. et al.Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial.Ophthalmology. 2004; 111: 218-224Abstract Full Text Full Text PDF PubMed Scopus (391) Google Scholar it is less certain whether they are safe and efficacious for more extended periods. Another unanswered question is whether the duration of macular edema at the time of treatment affects the anatomical and functional response. We have conducted a randomized, double-masked, placebo-controlled clinical trial of IVTA for DME in which all eyes also received laser treatment according to prospectively defined rules.1Sutter F.K. Simpson J.M. Gillies M.C. 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. 2004; 111: 2044-2049Abstract Full Text Full Text PDF PubMed Scopus (209) Google Scholar, 4Gillies M.C. Sutter F.K. Simpson J.M. et al.Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial.Ophthalmology. 2006; 113: 1533-1538Abstract Full Text Full Text PDF PubMed Scopus (368) Google Scholar After 2 years, there was a significant improvement in best-corrected logMAR visual acuity and central macular thickness (CMT). In order to study whether the patients who had initially received placebo treatment might still do as well as those who received IVTA, the trial became open label from 2 years. All eyes, including those that originally received placebo treatment, received IVTA according to prospectively defined guidelines. We present the third year results of the study, including the first 3-year safety data from a prospectively defined cohort. Eligibility criteria, procedures, and statistical methods for this trial have been previously described.3Massin P. Audren F. Haouchine B. et al.Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial.Ophthalmology. 2004; 111: 218-224Abstract Full Text Full Text PDF PubMed Scopus (391) Google Scholar, 4Gillies M.C. Sutter F.K. Simpson J.M. et al.Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial.Ophthalmology. 2006; 113: 1533-1538Abstract Full Text Full Text PDF PubMed Scopus (368) Google Scholar Sixty-nine eyes of 43 patients were entered into the study, with 34 eyes randomized to receive active treatment, and 35 were given placebo. Three-year data were available for 48/69 (70%) eyes of 29/43 (67%) patients; 21 eyes of 14 patients were lost to follow-up, of which 10 had initially received placebo and 11 had initially received IVTA. For the eyes with missing 3-year data, the last observation was carried forward. A greater proportion of eyes from the initial IVTA group, 16/33 (48%), had an improvement in the primary outcome, gain of 5 or more letters from baseline, than from the group that initially received placebo 9/34 (26%), but this difference was of borderline significance (zGEE = 1.74, P = 0.08). Only 5/33 (15%) initial IVTA eyes lost 10 or more letters compared with 10/34 (29%) initial placebo eyes. In contrast to the apparent persistent difference in visual acuity results between the 2 groups, CMT had decreased the same amount at 3 years for the initial IVTA group (133 μm) as for the initial placebo group (130 μm). During the third year of the study, a similar proportion of eyes from the 2 groups had macular edema that warranted laser treatment: initial IVTA, 12/29 (41%); initial placebo, 10/28 (36%). Having peaked in the second year, the incidence of cataract surgery declined, with 2/11 (18%) eyes from the initial-IVTA group that were phakic at the beginning of the third year requiring cataract surgery. It was reassuring that no other serious adverse events were observed. We found that the initial beneficial effect of treatment continued to hold up more or less with respect to the primary outcome, with 48% of initial-IVTA eyes gaining 5 or more letters since baseline compared with 56% after 2 years.4Gillies M.C. Sutter F.K. Simpson J.M. et al.Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial.Ophthalmology. 2006; 113: 1533-1538Abstract Full Text Full Text PDF PubMed Scopus (368) Google Scholar A higher proportion, however, had lost 5 or more letters after 3 years than at 2 years (30% vs. 18%). Eyes that initially received IVTA still seemed to have better visual acuity outcomes after 3 years than eyes that had initially received placebo, although there was no difference in mean CMT between the 2 groups. To a certain extent, this may have been caused by spontaneous improvement in the initial placebo group that was seen at 2 years, but these eyes were eligible to receive intravitreal triamcinolone in the third year if they had persistent edema with impaired vision. Thus, judging by the equal requirement for laser by the 2 groups in the third year, treatment with IVTA did not lead to faster or more complete “drug-free” resolution of DME, but it may have limited irreversible damage that may have occurred in the group in which treatment was delayed. IVTA should not be given lightly. A recent, large, randomized, clinical trial established that laser is superior to IVTA as a first-line treatment for DME.5Diabetic Retinopathy Clinical Research NetworkA randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema.Ophthalmology. 2008; 115: 1447-1459Abstract Full Text Full Text PDF PubMed Scopus (525) Google Scholar In carefully selected cases, however, for example eyes that have failed laser treatment, we believe that IVTA still has a valuable role in preventing loss of vision. The Study's Safety Monitoring Committee comprised Dr. Jeremy Smith, Dr. Jie Jin Wang, and Mr. Paul Power." @default.
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