Sustained delivery fluocinolone acetonide vitreous implants: long-term benefit in patients with chronic diabetic macular edema
José Cunha-Vaz, Paul Ashton, Raymond Iezzi, Peter Campochiaro, Pravin U Dugel, Frank G Holz, Michel Weber, Ronald P Danis, Baruch D Kuppermann, Clare Bailey, Kathleen Billman, Barry Kapik, Frances Kane, Ken Green, FAME Study Group, P Abraham, R Navarro Alemany, J Mones, V Alfaro, A Antoszyk, M Antworth, J Araiz, C Bailey, C Baker, B Berger, P Blackburn, K Blinder, S Bloom, D Boyer, D Brown, M Busquets, P A Campochiaro, K Carnevale, R Chace, C Chan, M Chen, K Wong, S Chen, N Chaudhry, T Ciulla, J Cohen, H Datta, D Dehning, U Desai, M Ober, R Devenyi, D DiLoreto Jr, L Duarte, R Equi, F Falcao-Reis, S Feman, A Fernández-Vega, M Forminska-Kapuscik, A Gierek-Lapinska, R Frank, R Iezzi, J Galic, M Oh, S Garg, B Garretson, L Glazer, J Gonder, V Gonzalez, V Vann, J Gunn, A Gupta, J Gross, L Halperin, S Hariprasad, E Herba, D Hoffert, F Holz, G Hubbard, N Hussain, G Jaffe, B Joondeph, A Kampik, R Katz, B Kim, M Young, V Kozousek, B Kupperman, H Lazarus, M Levitan, A Lotery, S Madreperla, D Marcus, J Marx, J Mason, W McLaughlin Jr, U Menchini, G Mincey, V Narendran, J Olson, S Patel, P Pavan, J Prensky, E Quinlan, K Oh, H Quiroz-Mercado, N Faberowski, A Ciardella, R Ramakrishnan, M Rauser, R Ravindran, C Regillo, E Reichel, M Rivers, W Rosenthal, J Ruiz-Moreno, N Sabates, S Sanislo, C Schwartz, T Sharma, G Sharuk, G Soubrane, K Sun, A Thach, M Tolentino, T Topping, E Traverso, S Uwaydat, A Safar, M Varenhorst, J Walker, R Wang, M Weber, Y Yang, José Cunha-Vaz, Paul Ashton, Raymond Iezzi, Peter Campochiaro, Pravin U Dugel, Frank G Holz, Michel Weber, Ronald P Danis, Baruch D Kuppermann, Clare Bailey, Kathleen Billman, Barry Kapik, Frances Kane, Ken Green, FAME Study Group, P Abraham, R Navarro Alemany, J Mones, V Alfaro, A Antoszyk, M Antworth, J Araiz, C Bailey, C Baker, B Berger, P Blackburn, K Blinder, S Bloom, D Boyer, D Brown, M Busquets, P A Campochiaro, K Carnevale, R Chace, C Chan, M Chen, K Wong, S Chen, N Chaudhry, T Ciulla, J Cohen, H Datta, D Dehning, U Desai, M Ober, R Devenyi, D DiLoreto Jr, L Duarte, R Equi, F Falcao-Reis, S Feman, A Fernández-Vega, M Forminska-Kapuscik, A Gierek-Lapinska, R Frank, R Iezzi, J Galic, M Oh, S Garg, B Garretson, L Glazer, J Gonder, V Gonzalez, V Vann, J Gunn, A Gupta, J Gross, L Halperin, S Hariprasad, E Herba, D Hoffert, F Holz, G Hubbard, N Hussain, G Jaffe, B Joondeph, A Kampik, R Katz, B Kim, M Young, V Kozousek, B Kupperman, H Lazarus, M Levitan, A Lotery, S Madreperla, D Marcus, J Marx, J Mason, W McLaughlin Jr, U Menchini, G Mincey, V Narendran, J Olson, S Patel, P Pavan, J Prensky, E Quinlan, K Oh, H Quiroz-Mercado, N Faberowski, A Ciardella, R Ramakrishnan, M Rauser, R Ravindran, C Regillo, E Reichel, M Rivers, W Rosenthal, J Ruiz-Moreno, N Sabates, S Sanislo, C Schwartz, T Sharma, G Sharuk, G Soubrane, K Sun, A Thach, M Tolentino, T Topping, E Traverso, S Uwaydat, A Safar, M Varenhorst, J Walker, R Wang, M Weber, Y Yang
Abstract
Purpose: To present the safety and efficacy of intravitreal implants releasing 0.2 μg/day fluocinolone acetonide (FAc) in patients with chronic versus nonchronic diabetic macular edema (DME). To assess ocular characteristics, anatomic changes, and re-treatment and ancillary therapies that may explain the differential treatment effect seen with intravitreal implants releasing FAc 0.2 μg/day in patients with chronic and nonchronic DME. An overall benefit-to-risk assessment for the FAc 0.2-μg/day and FAc 0.5-μg/day doses has been reported previously.
Design: Preplanned subgroup analysis of chronic (duration of diagnosis, ≥3 years) and nonchronic (duration of diagnosis, <3 years) DME in patients from 2 randomized, sham injection-controlled, double-masked, multicenter clinical trials.
Participants: Patients with persistent DME despite 1 or more macular laser treatment were randomized 1:2:2 to sham injection (n = 185), FAc 0.2 μg/day (n = 375), or FAc 0.5 μg/day (n = 393).
Methods: Patients received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on re-treatment criteria, additional masked study drug could be given after 1 year.
Main outcome measures: Percentage of patients with improvement of 15 letters or more from baseline. Secondary outcomes included other parameters of visual function and foveal thickness.
Results: At month 36, the difference between FAc 0.2 μg/day and sham control in the percentage of patients who gained 15 letters or more was significantly greater in chronic DME patients (FAc 0.2 μg/day, 34.0% vs. sham, 13.4%; P<0.001), compared with patients with nonchronic DME (FAc 0.2 μg/day, 22.3% vs. sham, 27.8%; P = 0.275). The greater response in patients with chronic DME was not associated with baseline ocular characteristics, changes in anatomic features, or differences in re-treatment or ancillary therapies. The ocular adverse event profile for FAc 0.2 μg/day was similar regardless of DME duration.
Conclusions: This is the first published analysis correlating duration of diagnosis of DME with treatment effect. In patients with chronic DME, FAc 0.2 μg/day provides substantial visual benefit for up to 3 years and would provide an option for patients who do not respond to other therapy.
Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Source: PubMed