1. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study
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Augustin, A. J., Kuppermann, B. D., Lanzetta, P., Loewenstein, A., X. -Y., Li, Cui, H., Hashad, Y., Whitcup, S. M., Abujamra, S., Acton, J., Ali, F., Antoszyk, A., Awh, C. C., Barak, A., Bartz-Schmidt, K. U., Baumal, C. R., Belfort, R. Jr., Bhende, M., Boyer, D. S., Bridges, W. Z. Jr., Brown, D. M., Carmichael, T., Carnevale, K., Casella, A. M., Chang, T., Chechik, D., Chen, S. -N., Chong, L. P., Chong, V., Corwin, J., Creuzot-Garcher, C., Cruess, A., Daniell, M., De Avila, M. P., De Moraes, H. V. Jr., Devenyi, R. G., Doft, B. H., Donaldson, M., Dreyer, R., Eliott, D., Engel, H. M., Ernest, J., Essman, T. F., Falcone, P. M., Fekrat, S., Ferencz, J. R., Ferreira, J. L., Figueira, J., Fiser, I., Foster, B., Fox, G. M., Freeman, W. R., Garg, S. P., Gillies, M., Glaser, D., Goldstein, B. G., Gomes, A. M. V., Gonder, J. R., Gopal, L., Gous, P., Gupta, A., Halperin, L., Han, D., Hariprasad, S. M., Holz, F. G., Kaiser, P., Kalvodova, B., Katz, B., Katz, R. S., Kecik, D., Kellaway, J., Klemperer, I., Lattanzio, R., Lee, W. -K., Lehr, J., Leys, M., Loose, I., Lotery, A., D. -W., Lu, Mccartney, P., Majji, A. B., Martinez, J. A., Massin, P., Maturi, R. K., Menchini, U., Menon, G., Michels, M., Midena, E., Miller, J. Jr., Mitchell, P., Moisseiev, J., Morse, L., Navarro, R., Nemeth, J., Newland, H., Newsom, R., Nichols, J., Orellana, J., Orzalesi, N., Paranhos, A. Jr., Park, R., Park, S., Parodi, M. B., Pavan, P. R., Peace, J., Perez-Ortiz, D. J., Pollack, A., Ramaswamy, K., Ratnakaram, R., Ravalico, G., Rehak, J., Rezaei, K., Rizzo, S., Rodriguez-Alvira, F. J., Romanet, J. -P., Rose, S., Rosen, R. B., Rossetti, L., Ruiz-Moreno, J. M., Sadda, S., Sall, K., Sandner, D., Sanz, A. F. -V., Sartani, G., Schmickler, S., Schwartz, S. D., Sharma, Y. R., Sheu, S. -J., Singer, M., Sivaprasad, S., Soubrane, G., Soucek, P., Souied, E. H., Staurenghi, G., Studnicka, J., Suarez-Figueroa, M., Takahashi, W. Y., Tognetto, D., Tsai, P. L., Ulanski, L. J., H. S., Uy, Varano, M., Veith, M., Vicha, I., Viola, F., Visser, L., Weinberger, D., Wing, G. L., Wong, E., Wong, T. Y., Wylegala, E., Yan, J., Yoon, Y. H., Young, L. H., H. G., Yu, Zimmer-Galler, I. E., Augustin, Aj, Kuppermann, Bd, Lanzetta, P, Loewenstein, A, Li, Xy, Cui, H, Hashad, Y, Whitcup, Sm, on behalf of for the Ozurdex MEAD Study, Group, Battaglia Parodi, M, Augustin, A. J., Kuppermann, B. D., Lanzetta, P., Loewenstein, A., Li, X. -Y., Cui, H., Hashad, Y., Whitcup, S. M., Abujamra, S., Acton, J., Ali, F., Antoszyk, A., Awh, C. C., Barak, A., Bartz-Schmidt, K. U., Baumal, C. R., Belfort, R., Bhende, M., Boyer, D. S., Bridges, W. Z., Brown, D. M., Carmichael, T., Carnevale, K., Casella, A. M., Chang, T., Chechik, D., Chen, S. -N., Chong, L. P., Chong, V., Corwin, J., Creuzot-Garcher, C., Cruess, A., Daniell, M., De Avila, M. P., De Moraes, H. V., Devenyi, R. G., Doft, B. H., Donaldson, M., Dreyer, R., Eliott, D., Engel, H. M., Ernest, J., Essman, T. F., Falcone, P. M., Fekrat, S., Ferencz, J. R., Ferreira, J. L., Figueira, J., Fiser, I., Foster, B., Fox, G. M., Freeman, W. R., Garg, S. P., Gillies, M., Glaser, D., Goldstein, B. G., Gomes, A. M. V., Gonder, J. R., Gopal, L., Gous, P., Gupta, A., Halperin, L., Han, D., Hariprasad, S. M., Holz, F. G., Kaiser, P., Kalvodova, B., Katz, B., Katz, R. S., Kecik, D., Kellaway, J., Klemperer, I., Lattanzio, R., Lee, W. -K., Lehr, J., Leys, M., Loose, I., Lotery, A., Lu, D. -W., Mccartney, P., Majji, A. B., Martinez, J. A., Massin, P., Maturi, R. K., Menchini, U., Menon, G., Michels, M., Midena, E., Miller, J., Mitchell, P., Moisseiev, J., Morse, L., Navarro, R., Nemeth, J., Newland, H., Newsom, R., Nichols, J., Orellana, J., Orzalesi, N., Paranhos, A., Park, R., Park, S., Parodi, M. B., Pavan, P. R., Peace, J., Perez-Ortiz, D. J., Pollack, A., Ramaswamy, K., Ratnakaram, R., Ravalico, G., Rehak, J., Rezaei, K., Rizzo, S., Rodriguez-Alvira, F. J., Romanet, J. -P., Rose, S., Rosen, R. B., Rossetti, L., Ruiz-Moreno, J. M., Sadda, S., Sall, K., Sandner, D., Sanz, A. F. -V., Sartani, G., Schmickler, S., Schwartz, S. D., Sharma, Y. R., Sheu, S. -J., Singer, M., Sivaprasad, S., Soubrane, G., Soucek, P., Souied, E. H., Staurenghi, G., Studnicka, J., Suarez-Figueroa, M., Takahashi, W. Y., Tognetto, D., Tsai, P. L., Ulanski, L. J., Uy, H. S., Varano, M., Veith, M., Vicha, I., Viola, F., Visser, L., Weinberger, D., Wing, G. L., Wong, E., Wong, T. Y., Wylegala, E., Yan, J., Yoon, Y. H., Young, L. H., Yu, H. G., and Zimmer-Galler, I. E.
- Subjects
Male ,Vascular Endothelial Growth Factor A ,Visual acuity ,Triamcinolone acetonide ,genetic structures ,medicine.medical_treatment ,Visual Acuity ,Angiogenesis Inhibitors ,Drug Implant ,Triamcinolone Acetonide ,Dexamethasone ,Immunosuppressive Agent ,Glucocorticoid ,Diabetic retinopathy ,Dexamethasone Intravitreal Implant ,Corticosteroid ,Drug delivery ,Implant ,Macular edema ,Aged ,Diabetic Retinopathy ,Drug Implants ,Female ,Glucocorticoids ,Humans ,Immunosuppressive Agents ,Intravitreal Injections ,Macular Edema ,Middle Aged ,Retreatment ,Tomography, Optical Coherence ,Ophthalmology ,Tomography ,General Medicine ,medicine.symptom ,medicine.drug ,Angiogenesis Inhibitor ,Human ,Research Article ,medicine.medical_specialty ,Subgroup analysis ,medicine ,business.industry ,Intravitreal Injection ,Cataract surgery ,medicine.disease ,eye diseases ,Optical Coherence ,business - Abstract
Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34–68 Early Treatment Diabetic Retinopathy Study letters (20/200–20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n = 261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was −126.1 μm with DEX 0.7 versus −39.0 μm with sham (P
- Published
- 2015