Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study

Albert J. Augustin; Baruch D. Kuppermann; Paolo Lanzetta; Anat Loewenstein; Xiao-Yan Li; Harry Cui; Yehia Hashad; Scott M. Whitcup; Suel Abujamra; James Acton; Fareed Ali; Andrew Antoszyk; Carl C. Awh; Adiel Barak; Karl Ulrich Bartz-Schmidt; Caroline R. Baumal; Rubens Belfort; Muna Bhende; David S. Boyer; William Z. Bridges; David M. Brown; Trevor Carmichael; Ken Carnevale; Antonio M. Casella; Tom Chang; Daniel Chechik; San-Ni Chen; Lawrence P. Chong; Victor Chong; Joel Corwin; Catherine Creuzot-Garcher; Alan Cruess; Mark Daniell; Marcos P. De Avila; Haroldo Vieira De Moraes; Robert G. Devenyi; Bernard H. Doft; Mark Donaldson; Richard Dreyer; Dean Eliott; Harry M. Engel; Jan Ernest; Thomas F. Essman; Philip M. Falcone; Sharon Fekrat; Joseph R. Ferencz; Joao L. Ferreira; Joao Figueira; Ivan Fiser; Bradley Foster; Gregory M. Fox; William R. Freeman; S. P. Garg; Mark Gillies; David Glaser; Burton G. Goldstein; Andre M. V. Gomes; John R. Gonder; Lingam Gopal; Petrus Gous; Amod Gupta; Anurag Gupta; Lawrence Halperin; Dennis Han; Seenu M. Hariprasad; Frank G. Holz; Peter Kaiser; Bohdana Kalvodova; Barrett Katz; Randy S. Katz; Dariusz Kecik; Judianne Kellaway; Itamar Klemperer; Rosangela Lattanzio; Won-Ki Lee; John Lehr; Monique Leys; Isaac Loose; Andrew Lotery; Da-Wen Lu; Paul Mccartney; Ajit B. Majji; Jose A. Martinez; Pascale Massin; Raj K. Maturi; Ugo Menchini; Geeta Menon; Mark Michels; Edoardo Midena; James Miller; Paul Mitchell; Joseph Moisseiev; Lawrence Morse; Rafael Navarro; Janos Nemeth; Henry Newland; Richard Newsom; John Nichols; Juan Orellana; Nicola Orzalesi; Augusto Paranhos; Robert Park; Susanna Park; Maurizio Battaglia Parodi; Peter R. Pavan; James Peace; Don J. Perez-Ortiz; Ayala Pollack; Kim Ramaswamy; Ramakrishna Ratnakaram; Giuseppe Ravalico; Jiri Rehak; Kourous Rezaei; Stanislao Rizzo; Francisco J. Rodriguez-Alvira; Jean-Paul Romanet; Steven Rose; Richard B. Rosen; Luca Rossetti; Lodovico Rossetti; José Maria Ruiz-Moreno; Srinivas Sadda; Kenneth Sall; Dirk Sandner; Alvaro Fernandez-Vega Sanz; Gil Sartani; Stefanie Schmickler; Steven D. Schwartz; Y. R. Sharma; Shwu-Jiuan Sheu; Michael Singer; Sobha Sivaprasad; Gisele Soubrane; Petr Soucek; Eric H. Souied; Giovanni Staurenghi; Jan Studnicka; Marta Suarez-Figueroa; Walter Y. Takahashi; Daniele Tognetto; Patrick L. Tsai; Lawrence J. Ulanski; Harvey S. Uy; Monica Varano; Miroslav Veith; Igor Vicha; Francesco Viola; Linda Visser; Dov Weinberger; Glenn L. Wing; Edmund Wong; Tien Y. Wong; Edward Wylegala; Jiong Yan; Julia Yan; Young Hee Yoon; Lucy H. Young; Hyeong G. Yu; Ingrid E. Zimmer-Galler

doi:10.1186/s12886-015-0148-2

Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study

Albert J. Augustin, Baruch D. Kuppermann, Paolo Lanzetta, Anat Loewenstein, Xiao-Yan Li, Harry Cui, Yehia Hashad, Scott M. Whitcup, Suel Abujamra, James Acton, Fareed Ali, Andrew Antoszyk, Carl C. Awh, Adiel Barak, Karl Ulrich Bartz-Schmidt, Caroline R. Baumal, Rubens Belfort, Muna Bhende, David S. Boyer, William Z. BridgesDavid M. Brown, Trevor Carmichael, Ken Carnevale, Antonio M. Casella, Tom Chang, Daniel Chechik, San-Ni Chen, Lawrence P. Chong, Victor Chong, Joel Corwin, Catherine Creuzot-Garcher, Alan Cruess, Mark Daniell, Marcos P. De Avila, Haroldo Vieira De Moraes, Robert G. Devenyi, Bernard H. Doft, Mark Donaldson, Richard Dreyer, Dean Eliott, Harry M. Engel, Jan Ernest, Thomas F. Essman, Philip M. Falcone, Sharon Fekrat, Joseph R. Ferencz, Joao L. Ferreira, Joao Figueira, Ivan Fiser, Bradley Foster, Gregory M. Fox, William R. Freeman, S. P. Garg, Mark Gillies, David Glaser, Burton G. Goldstein, Andre M. V. Gomes, John R. Gonder, Lingam Gopal, Petrus Gous, Amod Gupta, Anurag Gupta, Lawrence Halperin, Dennis Han, Seenu M. Hariprasad, Frank G. Holz, Peter Kaiser, Bohdana Kalvodova, Barrett Katz, Randy S. Katz, Dariusz Kecik, Judianne Kellaway, Itamar Klemperer, Rosangela Lattanzio, Won-Ki Lee, John Lehr, Monique Leys, Isaac Loose, Andrew Lotery, Da-Wen Lu, Paul Mccartney, Ajit B. Majji, Jose A. Martinez, Pascale Massin, Raj K. Maturi, Ugo Menchini, Geeta Menon, Mark Michels, Edoardo Midena, James Miller, Paul Mitchell, Joseph Moisseiev, Lawrence Morse, Rafael Navarro, Janos Nemeth, Henry Newland, Richard Newsom, John Nichols, Juan Orellana, Nicola Orzalesi, Augusto Paranhos, Robert Park, Susanna Park, Maurizio Battaglia Parodi, Peter R. Pavan, James Peace, Don J. Perez-Ortiz, Ayala Pollack, Kim Ramaswamy, Ramakrishna Ratnakaram, Giuseppe Ravalico, Jiri Rehak, Kourous Rezaei, Stanislao Rizzo, Francisco J. Rodriguez-Alvira, Jean-Paul Romanet, Steven Rose, Richard B. Rosen, Luca Rossetti, Lodovico Rossetti, José Maria Ruiz-Moreno, Srinivas Sadda, Kenneth Sall, Dirk Sandner, Alvaro Fernandez-Vega Sanz, Gil Sartani, Stefanie Schmickler, Steven D. Schwartz, Y. R. Sharma, Shwu-Jiuan Sheu, Michael Singer, Sobha Sivaprasad, Gisele Soubrane, Petr Soucek, Eric H. Souied, Giovanni Staurenghi, Jan Studnicka, Marta Suarez-Figueroa, Walter Y. Takahashi, Daniele Tognetto, Patrick L. Tsai, Lawrence J. Ulanski, Harvey S. Uy, Monica Varano, Miroslav Veith, Igor Vicha, Francesco Viola, Linda Visser, Dov Weinberger, Glenn L. Wing, Edmund Wong, Tien Y. Wong, Edward Wylegala, Jiong Yan, Julia Yan, Young Hee Yoon, Lucy H. Young, Hyeong G. Yu, Ingrid E. Zimmer-Galler

Risultato della ricerca: Contributo in rivista › Articolo in rivista

Abstract

Background: 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. Methods: 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. Results: 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 < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.

Lingua originale	English
pagine (da-a)	2-9
Numero di pagine	8
Rivista	BMC Ophthalmology
Volume	15
DOI	https://doi.org/10.1186/s12886-015-0148-2
Stato di pubblicazione	Pubblicato - 2015

Keywords

Corticosteroid
Dexamethasone
Diabetic retinopathy
Drug delivery
Implant
Macular edema

OSS delle Nazioni Unite

Questo processo contribuisce al raggiungimento dei seguenti obiettivi di sviluppo sostenibile

Accesso al documento

10.1186/s12886-015-0148-2

Altri file e collegamenti

Link a IRIS PubliCatt

Cita questo

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., ... Zimmer-Galler, I. E. (2015). Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study. BMC Ophthalmology, 15, 2-9. https://doi.org/10.1186/s12886-015-0148-2

@article{51da2eb04930487292a0e7abdd859a96,

title = "Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study",

abstract = "Background: 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. Methods: 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. Results: 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 < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.",

keywords = "Corticosteroid, Dexamethasone, Diabetic retinopathy, Drug delivery, Implant, Macular edema, Corticosteroid, Dexamethasone, Diabetic retinopathy, Drug delivery, Implant, Macular edema",

author = "Augustin, {Albert J.} and Kuppermann, {Baruch D.} and Paolo Lanzetta and Anat Loewenstein and Xiao-Yan Li and Harry Cui and Yehia Hashad and Whitcup, {Scott M.} and Suel Abujamra and James Acton and Fareed Ali and Andrew Antoszyk and Awh, {Carl C.} and Adiel Barak and Bartz-Schmidt, {Karl Ulrich} and Baumal, {Caroline R.} and Rubens Belfort and Muna Bhende and Boyer, {David S.} and Bridges, {William Z.} and Brown, {David M.} and Trevor Carmichael and Ken Carnevale and Casella, {Antonio M.} and Tom Chang and Daniel Chechik and San-Ni Chen and Chong, {Lawrence P.} and Victor Chong and Joel Corwin and Catherine Creuzot-Garcher and Alan Cruess and Mark Daniell and {De Avila}, {Marcos P.} and {De Moraes}, {Haroldo Vieira} and Devenyi, {Robert G.} and Doft, {Bernard H.} and Mark Donaldson and Richard Dreyer and Dean Eliott and Engel, {Harry M.} and Jan Ernest and Essman, {Thomas F.} and Falcone, {Philip M.} and Sharon Fekrat and Ferencz, {Joseph R.} and Ferreira, {Joao L.} and Joao Figueira and Ivan Fiser and Bradley Foster and Fox, {Gregory M.} and Freeman, {William R.} and Garg, {S. P.} and Mark Gillies and David Glaser and Goldstein, {Burton G.} and Gomes, {Andre M. V.} and Gonder, {John R.} and Lingam Gopal and Petrus Gous and Amod Gupta and Anurag Gupta and Lawrence Halperin and Dennis Han and Hariprasad, {Seenu M.} and Holz, {Frank G.} and Peter Kaiser and Bohdana Kalvodova and Barrett Katz and Katz, {Randy S.} and Dariusz Kecik and Judianne Kellaway and Itamar Klemperer and Rosangela Lattanzio and Won-Ki Lee and John Lehr and Monique Leys and Isaac Loose and Andrew Lotery and Da-Wen Lu and Paul Mccartney and Majji, {Ajit B.} and Martinez, {Jose A.} and Pascale Massin and Maturi, {Raj K.} and Ugo Menchini and Geeta Menon and Mark Michels and Edoardo Midena and James Miller and Paul Mitchell and Joseph Moisseiev and Lawrence Morse and Rafael Navarro and Janos Nemeth and Henry Newland and Richard Newsom and John Nichols and Juan Orellana and Nicola Orzalesi and Augusto Paranhos and Robert Park and Susanna Park and Parodi, {Maurizio Battaglia} and Pavan, {Peter R.} and James Peace and Perez-Ortiz, {Don J.} and Ayala Pollack and Kim Ramaswamy and Ramakrishna Ratnakaram and Giuseppe Ravalico and Jiri Rehak and Kourous Rezaei and Stanislao Rizzo and Rodriguez-Alvira, {Francisco J.} and Jean-Paul Romanet and Steven Rose and Rosen, {Richard B.} and Luca Rossetti and Lodovico Rossetti and Ruiz-Moreno, {Jos{\'e} Maria} and Srinivas Sadda and Kenneth Sall and Dirk Sandner and Sanz, {Alvaro Fernandez-Vega} and Gil Sartani and Stefanie Schmickler and Schwartz, {Steven D.} and Sharma, {Y. R.} and Shwu-Jiuan Sheu and Michael Singer and Sobha Sivaprasad and Gisele Soubrane and Petr Soucek and Souied, {Eric H.} and Giovanni Staurenghi and Jan Studnicka and Marta Suarez-Figueroa and Takahashi, {Walter Y.} and Daniele Tognetto and Tsai, {Patrick L.} and Ulanski, {Lawrence J.} and Uy, {Harvey S.} and Monica Varano and Miroslav Veith and Igor Vicha and Francesco Viola and Linda Visser and Dov Weinberger and Wing, {Glenn L.} and Edmund Wong and Wong, {Tien Y.} and Edward Wylegala and Jiong Yan and Julia Yan and Yoon, {Young Hee} and Young, {Lucy H.} and Yu, {Hyeong G.} and Zimmer-Galler, {Ingrid E.}",

year = "2015",

doi = "10.1186/s12886-015-0148-2",

language = "English",

volume = "15",

pages = "2--9",

journal = "BMC Ophthalmology",

issn = "1471-2415",

publisher = "BioMed Central Ltd.",

}

Augustin, AJ, Kuppermann, BD, Lanzetta, P, Loewenstein, A, Li, X-Y, Cui, H, Hashad, Y, Whitcup, SM, Abujamra, S, Acton, J, Ali, F, Antoszyk, A, Awh, CC, Barak, A, Bartz-Schmidt, KU, Baumal, CR, Belfort, R, Bhende, M, Boyer, DS, Bridges, WZ, Brown, DM, Carmichael, T, Carnevale, K, Casella, AM, Chang, T, Chechik, D, Chen, S-N, Chong, LP, Chong, V, Corwin, J, Creuzot-Garcher, C, Cruess, A, Daniell, M, De Avila, MP, De Moraes, HV, Devenyi, RG, Doft, BH, Donaldson, M, Dreyer, R, Eliott, D, Engel, HM, Ernest, J, Essman, TF, Falcone, PM, Fekrat, S, Ferencz, JR, Ferreira, JL, Figueira, J, Fiser, I, Foster, B, Fox, GM, Freeman, WR, Garg, SP, Gillies, M, Glaser, D, Goldstein, BG, Gomes, AMV, Gonder, JR, Gopal, L, Gous, P, Gupta, A, Gupta, A, Halperin, L, Han, D, Hariprasad, SM, Holz, FG, Kaiser, P, Kalvodova, B, Katz, B, Katz, RS, 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, AB, Martinez, JA, Massin, P, Maturi, RK, 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, MB, Pavan, PR, Peace, J, Perez-Ortiz, DJ, Pollack, A, Ramaswamy, K, Ratnakaram, R, Ravalico, G, Rehak, J, Rezaei, K, Rizzo, S, Rodriguez-Alvira, FJ, Romanet, J-P, Rose, S, Rosen, RB, Rossetti, L, Rossetti, L, Ruiz-Moreno, JM, Sadda, S, Sall, K, Sandner, D, Sanz, AF-V, Sartani, G, Schmickler, S, Schwartz, SD, Sharma, YR, Sheu, S-J, Singer, M, Sivaprasad, S, Soubrane, G, Soucek, P, Souied, EH, Staurenghi, G, Studnicka, J, Suarez-Figueroa, M, Takahashi, WY, Tognetto, D, Tsai, PL, Ulanski, LJ, Uy, HS, Varano, M, Veith, M, Vicha, I, Viola, F, Visser, L, Weinberger, D, Wing, GL, Wong, E, Wong, TY, Wylegala, E, Yan, J, Yan, J, Yoon, YH, Young, LH, Yu, HG & Zimmer-Galler, IE 2015, 'Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study', BMC Ophthalmology, vol. 15, pagg. 2-9. https://doi.org/10.1186/s12886-015-0148-2

TY - JOUR

T1 - Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study

AU - Augustin, Albert J.

AU - Kuppermann, Baruch D.

AU - Lanzetta, Paolo

AU - Loewenstein, Anat

AU - Li, Xiao-Yan

AU - Cui, Harry

AU - Hashad, Yehia

AU - Whitcup, Scott M.

AU - Abujamra, Suel

AU - Acton, James

AU - Ali, Fareed

AU - Antoszyk, Andrew

AU - Awh, Carl C.

AU - Barak, Adiel

AU - Bartz-Schmidt, Karl Ulrich

AU - Baumal, Caroline R.

AU - Belfort, Rubens

AU - Bhende, Muna

AU - Boyer, David S.

AU - Bridges, William Z.

AU - Brown, David M.

AU - Carmichael, Trevor

AU - Carnevale, Ken

AU - Casella, Antonio M.

AU - Chang, Tom

AU - Chechik, Daniel

AU - Chen, San-Ni

AU - Chong, Lawrence P.

AU - Chong, Victor

AU - Corwin, Joel

AU - Creuzot-Garcher, Catherine

AU - Cruess, Alan

AU - Daniell, Mark

AU - De Avila, Marcos P.

AU - De Moraes, Haroldo Vieira

AU - Devenyi, Robert G.

AU - Doft, Bernard H.

AU - Donaldson, Mark

AU - Dreyer, Richard

AU - Eliott, Dean

AU - Engel, Harry M.

AU - Ernest, Jan

AU - Essman, Thomas F.

AU - Falcone, Philip M.

AU - Fekrat, Sharon

AU - Ferencz, Joseph R.

AU - Ferreira, Joao L.

AU - Figueira, Joao

AU - Fiser, Ivan

AU - Foster, Bradley

AU - Fox, Gregory M.

AU - Freeman, William R.

AU - Garg, S. P.

AU - Gillies, Mark

AU - Glaser, David

AU - Goldstein, Burton G.

AU - Gomes, Andre M. V.

AU - Gonder, John R.

AU - Gopal, Lingam

AU - Gous, Petrus

AU - Gupta, Amod

AU - Gupta, Anurag

AU - Halperin, Lawrence

AU - Han, Dennis

AU - Hariprasad, Seenu M.

AU - Holz, Frank G.

AU - Kaiser, Peter

AU - Kalvodova, Bohdana

AU - Katz, Barrett

AU - Katz, Randy S.

AU - Kecik, Dariusz

AU - Kellaway, Judianne

AU - Klemperer, Itamar

AU - Lattanzio, Rosangela

AU - Lee, Won-Ki

AU - Lehr, John

AU - Leys, Monique

AU - Loose, Isaac

AU - Lotery, Andrew

AU - Lu, Da-Wen

AU - Mccartney, Paul

AU - Majji, Ajit B.

AU - Martinez, Jose A.

AU - Massin, Pascale

AU - Maturi, Raj K.

AU - Menchini, Ugo

AU - Menon, Geeta

AU - Michels, Mark

AU - Midena, Edoardo

AU - Miller, James

AU - Mitchell, Paul

AU - Moisseiev, Joseph

AU - Morse, Lawrence

AU - Navarro, Rafael

AU - Nemeth, Janos

AU - Newland, Henry

AU - Newsom, Richard

AU - Nichols, John

AU - Orellana, Juan

AU - Orzalesi, Nicola

AU - Paranhos, Augusto

AU - Park, Robert

AU - Park, Susanna

AU - Parodi, Maurizio Battaglia

AU - Pavan, Peter R.

AU - Peace, James

AU - Perez-Ortiz, Don J.

AU - Pollack, Ayala

AU - Ramaswamy, Kim

AU - Ratnakaram, Ramakrishna

AU - Ravalico, Giuseppe

AU - Rehak, Jiri

AU - Rezaei, Kourous

AU - Rizzo, Stanislao

AU - Rodriguez-Alvira, Francisco J.

AU - Romanet, Jean-Paul

AU - Rose, Steven

AU - Rosen, Richard B.

AU - Rossetti, Luca

AU - Rossetti, Lodovico

AU - Ruiz-Moreno, José Maria

AU - Sadda, Srinivas

AU - Sall, Kenneth

AU - Sandner, Dirk

AU - Sanz, Alvaro Fernandez-Vega

AU - Sartani, Gil

AU - Schmickler, Stefanie

AU - Schwartz, Steven D.

AU - Sharma, Y. R.

AU - Sheu, Shwu-Jiuan

AU - Singer, Michael

AU - Sivaprasad, Sobha

AU - Soubrane, Gisele

AU - Soucek, Petr

AU - Souied, Eric H.

AU - Staurenghi, Giovanni

AU - Studnicka, Jan

AU - Suarez-Figueroa, Marta

AU - Takahashi, Walter Y.

AU - Tognetto, Daniele

AU - Tsai, Patrick L.

AU - Ulanski, Lawrence J.

AU - Uy, Harvey S.

AU - Varano, Monica

AU - Veith, Miroslav

AU - Vicha, Igor

AU - Viola, Francesco

AU - Visser, Linda

AU - Weinberger, Dov

AU - Wing, Glenn L.

AU - Wong, Edmund

AU - Wong, Tien Y.

AU - Wylegala, Edward

AU - Yan, Jiong

AU - Yan, Julia

AU - Yoon, Young Hee

AU - Young, Lucy H.

AU - Yu, Hyeong G.

AU - Zimmer-Galler, Ingrid E.

PY - 2015

Y1 - 2015

N2 - Background: 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. Methods: 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. Results: 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 < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.

AB - Background: 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. Methods: 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. Results: 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 < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.

KW - Corticosteroid

KW - Dexamethasone

KW - Diabetic retinopathy

KW - Drug delivery

KW - Implant

KW - Macular edema

KW - Corticosteroid

KW - Dexamethasone

KW - Diabetic retinopathy

KW - Drug delivery

KW - Implant

KW - Macular edema

UR - http://hdl.handle.net/10807/248074

U2 - 10.1186/s12886-015-0148-2

DO - 10.1186/s12886-015-0148-2

M3 - Article

SN - 1471-2415

VL - 15

SP - 2

EP - 9

JO - BMC Ophthalmology

JF - BMC Ophthalmology

ER -

Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study

Abstract

Keywords

OSS delle Nazioni Unite

Accesso al documento

Altri file e collegamenti

Fingerprint

Cita questo