OBJECTIVE: To provide pilot data on the safety and efficacy of anterior and posterior sub-Tenon injections of triamcinolone either alone or in combination with focal photocoagulation in the treatment of mild diabetic macular edema (DME). DESIGN: Prospective, phase II, multicenter, randomized clinical trial. PARTICIPANTS: One hundred nine patients (129 eyes) with mild DME and visual acuity 20/40 or better. METHODS: The participants were assigned randomly to receive either focal photocoagulation (n = 38), a 20-mg anterior sub-Tenon injection of triamcinolone (n = 23), a 20-mg anterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 25), a 40-mg posterior sub-Tenon injection of triamcinolone (n = 21), or a 40-mg posterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 22). Follow-up visits were performed at 4, 8, 17, and 34 weeks. MAIN OUTCOME MEASURES: Change in visual acuity and retinal thickness measured with optical coherence tomography (OCT). RESULTS: At baseline, mean visual acuity in the study eyes was 20/25 and mean OCT central subfield thickness was 328 mum. Changes in retinal thickening and in visual acuity were not significantly different among the 5 groups at 34 weeks (P = 0.46 and P = 0.94, respectively). There was a suggestion of a greater proportion of eyes having a central subfield thickness less than 250 mum at 17 weeks when the peribulbar triamcinolone was combined with focal photocoagulation. Elevated intraocular pressure and ptosis were adverse effects attributable to the injections. CONCLUSIONS: In cases of DME with good visual acuity, peribulbar triamcinolone, with or without focal photocoagulation, is unlikely to be of substantial benefit. Based on these results, a phase III trial to evaluate the benefit of these treatments for mild DME is not warranted.
RCT Entities:
OBJECTIVE: To provide pilot data on the safety and efficacy of anterior and posterior sub-Tenon injections of triamcinolone either alone or in combination with focal photocoagulation in the treatment of mild diabetic macular edema (DME). DESIGN: Prospective, phase II, multicenter, randomized clinical trial. PARTICIPANTS: One hundred nine patients (129 eyes) with mild DME and visual acuity 20/40 or better. METHODS: The participants were assigned randomly to receive either focal photocoagulation (n = 38), a 20-mg anterior sub-Tenon injection of triamcinolone (n = 23), a 20-mg anterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 25), a 40-mg posterior sub-Tenon injection of triamcinolone (n = 21), or a 40-mg posterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 22). Follow-up visits were performed at 4, 8, 17, and 34 weeks. MAIN OUTCOME MEASURES: Change in visual acuity and retinal thickness measured with optical coherence tomography (OCT). RESULTS: At baseline, mean visual acuity in the study eyes was 20/25 and mean OCT central subfield thickness was 328 mum. Changes in retinal thickening and in visual acuity were not significantly different among the 5 groups at 34 weeks (P = 0.46 and P = 0.94, respectively). There was a suggestion of a greater proportion of eyes having a central subfield thickness less than 250 mum at 17 weeks when the peribulbar triamcinolone was combined with focal photocoagulation. Elevated intraocular pressure and ptosis were adverse effects attributable to the injections. CONCLUSIONS: In cases of DME with good visual acuity, peribulbar triamcinolone, with or without focal photocoagulation, is unlikely to be of substantial benefit. Based on these results, a phase III trial to evaluate the benefit of these treatments for mild DME is not warranted.
Authors: S D Pendergast; T S Hassan; G A Williams; M S Cox; R R Margherio; P J Ferrone; B R Garretson; M T Trese Journal: Am J Ophthalmol Date: 2000-08 Impact factor: 5.258
Authors: Emmett T Cunningham; Anthony P Adamis; Michael Altaweel; Lloyd P Aiello; Neil M Bressler; Donald J D'Amico; Mauro Goldbaum; David R Guyer; Barrett Katz; Manju Patel; Steven D Schwartz Journal: Ophthalmology Date: 2005-10 Impact factor: 12.079
Authors: Quan Dong Nguyen; Sinan Tatlipinar; Syed Mahmood Shah; Julia A Haller; Edward Quinlan; Jennifer Sung; Ingrid Zimmer-Galler; Diana V Do; Peter A Campochiaro Journal: Am J Ophthalmol Date: 2006-08-02 Impact factor: 5.258
Authors: Lloyd Paul Aiello; Matthew D Davis; Aniz Girach; Keri A Kles; Roy C Milton; Matthew J Sheetz; Louis Vignati; Xin Eric Zhi Journal: Ophthalmology Date: 2006-09-20 Impact factor: 12.079
Authors: David J Browning; Adam R Glassman; Lloyd Paul Aiello; Roy W Beck; David M Brown; Donald S Fong; Neil M Bressler; Ronald P Danis; James L Kinyoun; Quan Dong Nguyen; Abdhish R Bhavsar; Justin Gottlieb; Dante J Pieramici; Michael E Rauser; Rajendra S Apte; Jennifer I Lim; Päivi H Miskala Journal: Ophthalmology Date: 2006-11-21 Impact factor: 12.079
Authors: Roy W Beck; Pamela S Moke; Andrew H Turpin; Frederick L Ferris; John Paul SanGiovanni; Chris A Johnson; Eileen E Birch; Danielle L Chandler; Terry A Cox; R Clifford Blair; Raymond T Kraker Journal: Am J Ophthalmol Date: 2003-02 Impact factor: 5.258
Authors: Melissa Wagner-Schuman; Adam M Dubis; Rick N Nordgren; Yuming Lei; Daniel Odell; Hellen Chiao; Eric Weh; William Fischer; Yusufu Sulai; Alfredo Dubra; Joseph Carroll Journal: Invest Ophthalmol Vis Sci Date: 2011-02-01 Impact factor: 4.799
Authors: Ronald P Danis; Ingrid U Scott; Haijing Qin; Michael M Altaweel; Neil M Bressler; Susan B Bressler; David J Browning; Craig Kollman Journal: Retina Date: 2010 Nov-Dec Impact factor: 4.256
Authors: Amitha Domalpally; Barbara A Blodi; Ingrid U Scott; Michael S Ip; Neal L Oden; Andreas K Lauer; Paul C VanVeldhuisen Journal: Arch Ophthalmol Date: 2009-11