Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial
Baruch D Kuppermann, Michaella Goldstein, Raj K Maturi, Ayala Pollack, Michael Singer, Adnan Tufail, Dov Weinberger, Xiao-Yan Li, Ching-Chi Liu, Jean Lou, Scott M Whitcup, Ozurdex® ERIE Study Group, Saad Ahmad, Mario Manuel Alfaiate, Bruce Altman, Scott Anagnoste, Andrew N Antoszyk, Jennifer Arnold, Tariq Mehmood Aslam, Yehuda Assouline, Ruth Axer-Seigel, Carl W Baker, Francesco Bandello, Adeil Barak, Nazanin Barzideh, Darren J Bell, Matthew S Benz, Robert L Bergren, David Boyer, Jorg Bretzke, David M Brown, Amir Bukelman, Jason D Burns, Maria Luz Cachulo, Antonio Capone Jr, Ken B Carnevale, Jubyung Chae, Sadri Chahed, Robert Chong, Thomas G Chu, Hea-Won Chung, Hyewon Chung, Brian P Connolly, Clairton D'Souza, Jorge A DeLaChapa, Vincent A Deramo, Uday Desai, Mandeep Dhalla, Bernard H Doft, Mark Donaldson, John Downie, Kimberly Drenser, Lilianne Goncalves Duarte, Pravin U Dugel, Alexander M Eaton, Paul Andrew Edwards, Dean Eliott, Andrew W Eller, Michael J Elman, David Epstein, Robert A Equi, Ali Erginay, David Wayne Faber, Ralph Falkenstein, Babak Fardin, David M Fastenberg, Amani Fawzi, Joseph R Ferencz, Philip Ferrone, Joao Pereira Figueira, Richard S Fish, Ross Fitzsimmons, Thomas E Flynn, Pedro Fonseca, Alan J Franklin, Thomas Friberg, Jaime R Gaitan, Ron P Gallemore, Bruce Garretson, Alain Gaudric, Vincent Gaulino, Maria Gemenetzi, Joel George, A Tom Ghuman, Gila Gilady, Ronald Glatzer, David Goldenberg, Michaella Goldstein, Barry M Golub, Roy Allen Goodart, Alexandra Goz, Kenneth B Graham, Yoel Greenwald, Richard W Grodin, Ernest G Guillet, Rajen Gupta, Sunil Gupta, Edward F Hall, Lawrence Halperin, Richard Hanson, Shabeeha Rashed Hannan, Tarek Hassan, Yu-Guang He, Gad Heilweil, Lawrence Ho, Deborah Hoffert, Janet Jill Hopkins, Peter R Hurlbut-Miller, Tony Huynh, Ugo Introini, Randy S Katz, Arshad Khanani, Sam Khandhadia, June-Gone Kim, Rosa Y Kim, Archimidis Koskosas, Michal Kramer, Valerie Krivosic, Derek Y Kunimoto, Baruch D Kuppermann, Linda Lam, Paolo Lanzetta, Stephen Lash, Adrian M Lavina, Jason Lee, Jooyong Lee, Seong Young Lee, Ariela Len, Jong-Yoon Lim, Judy C Liu, Louis A Lobes, Andrew Lotery, Anat Lowenstein, Stephanie Lu, Andrew Luff, Idit Maharshak, Margaret Marcone, Rufino Martins da Silva, Stephen Mathias, Raj K Maturi, Francesca Menchini, Mark Michels, Karin Mimoni, Haia Morori-Katz, Mohammed Musadiq, John P Myers, Clara McAvoy, Stuart Mc-Gimpsey, Amy S Noffke, Roger L Novak, Michael David Ober, Kean T Oh, Karl R Olsen, Bish Pal, Donald W Park, Arun C Patel, Praveen Patel, Sunil S Patel, Matthew Paul, Joel A Pearlman, Giovanni Polini, Ayala Pollack, Matteo Prati, Fahd Quhill, Edward J Quinlan, Firas M Rahhal, Tushar Ranchod, Paul A Raskauskas, Pamela P Rath, J Brian Reed, Michael Regenbogen, Luisa Reis Ribeiro, Andrew Riley, Richard H Roe, Juan M Romero, Steven J Rose, Brett J Rosenblatt, Krista Rosenberg, Irit Rosenblatt, Michael H Rotberg, Alexander Rubowitz, Alan Ruby, Paul Ruggiero, Srinivas Sadda, Ramin Sarrafizadeh, Barry Schechter, Ori Segal, Scott Seo, Marco Setaccioli, Eric P Shakin, Jeffrey L Shakin, Ashish G Sharma, Yochai Shoshani, Shiri Shulman, Shiri Soudri-Zait, Giuliana Silvestri, Joanne Sims, Michael A Singer, Jack O Sipperley, Scott R Sneed, Glenn Stoller, Newman Sund, Homayoun Tabandeh, Barry Taney, Edgar L Thomas, Scott A Thomas, William Scott Thompson, Ron Tilford, Michelene Todd, Michael Trese, Tony Tsai, Adnan Tufail, Rafael Ufret-Vincenty, Hussein Wafapoor, Joseph P Walker, Alexander Walsh, Mark Walsh, Hao Wang, Dov Weinberger, Robert T Wendel, George Williams, Donald L Wilson, Glenn L Wing, Yanush Winkler, Richard Wintle, Tien P Wong, Sungjae Yang, Young-Hee Yoon, Leandro Zacharias, Yehoshua Zohar, Stephen Zuckerman, Baruch D Kuppermann, Michaella Goldstein, Raj K Maturi, Ayala Pollack, Michael Singer, Adnan Tufail, Dov Weinberger, Xiao-Yan Li, Ching-Chi Liu, Jean Lou, Scott M Whitcup, Ozurdex® ERIE Study Group, Saad Ahmad, Mario Manuel Alfaiate, Bruce Altman, Scott Anagnoste, Andrew N Antoszyk, Jennifer Arnold, Tariq Mehmood Aslam, Yehuda Assouline, Ruth Axer-Seigel, Carl W Baker, Francesco Bandello, Adeil Barak, Nazanin Barzideh, Darren J Bell, Matthew S Benz, Robert L Bergren, David Boyer, Jorg Bretzke, David M Brown, Amir Bukelman, Jason D Burns, Maria Luz Cachulo, Antonio Capone Jr, Ken B Carnevale, Jubyung Chae, Sadri Chahed, Robert Chong, Thomas G Chu, Hea-Won Chung, Hyewon Chung, Brian P Connolly, Clairton D'Souza, Jorge A DeLaChapa, Vincent A Deramo, Uday Desai, Mandeep Dhalla, Bernard H Doft, Mark Donaldson, John Downie, Kimberly Drenser, Lilianne Goncalves Duarte, Pravin U Dugel, Alexander M Eaton, Paul Andrew Edwards, Dean Eliott, Andrew W Eller, Michael J Elman, David Epstein, Robert A Equi, Ali Erginay, David Wayne Faber, Ralph Falkenstein, Babak Fardin, David M Fastenberg, Amani Fawzi, Joseph R Ferencz, Philip Ferrone, Joao Pereira Figueira, Richard S Fish, Ross Fitzsimmons, Thomas E Flynn, Pedro Fonseca, Alan J Franklin, Thomas Friberg, Jaime R Gaitan, Ron P Gallemore, Bruce Garretson, Alain Gaudric, Vincent Gaulino, Maria Gemenetzi, Joel George, A Tom Ghuman, Gila Gilady, Ronald Glatzer, David Goldenberg, Michaella Goldstein, Barry M Golub, Roy Allen Goodart, Alexandra Goz, Kenneth B Graham, Yoel Greenwald, Richard W Grodin, Ernest G Guillet, Rajen Gupta, Sunil Gupta, Edward F Hall, Lawrence Halperin, Richard Hanson, Shabeeha Rashed Hannan, Tarek Hassan, Yu-Guang He, Gad Heilweil, Lawrence Ho, Deborah Hoffert, Janet Jill Hopkins, Peter R Hurlbut-Miller, Tony Huynh, Ugo Introini, Randy S Katz, Arshad Khanani, Sam Khandhadia, June-Gone Kim, Rosa Y Kim, Archimidis Koskosas, Michal Kramer, Valerie Krivosic, Derek Y Kunimoto, Baruch D Kuppermann, Linda Lam, Paolo Lanzetta, Stephen Lash, Adrian M Lavina, Jason Lee, Jooyong Lee, Seong Young Lee, Ariela Len, Jong-Yoon Lim, Judy C Liu, Louis A Lobes, Andrew Lotery, Anat Lowenstein, Stephanie Lu, Andrew Luff, Idit Maharshak, Margaret Marcone, Rufino Martins da Silva, Stephen Mathias, Raj K Maturi, Francesca Menchini, Mark Michels, Karin Mimoni, Haia Morori-Katz, Mohammed Musadiq, John P Myers, Clara McAvoy, Stuart Mc-Gimpsey, Amy S Noffke, Roger L Novak, Michael David Ober, Kean T Oh, Karl R Olsen, Bish Pal, Donald W Park, Arun C Patel, Praveen Patel, Sunil S Patel, Matthew Paul, Joel A Pearlman, Giovanni Polini, Ayala Pollack, Matteo Prati, Fahd Quhill, Edward J Quinlan, Firas M Rahhal, Tushar Ranchod, Paul A Raskauskas, Pamela P Rath, J Brian Reed, Michael Regenbogen, Luisa Reis Ribeiro, Andrew Riley, Richard H Roe, Juan M Romero, Steven J Rose, Brett J Rosenblatt, Krista Rosenberg, Irit Rosenblatt, Michael H Rotberg, Alexander Rubowitz, Alan Ruby, Paul Ruggiero, Srinivas Sadda, Ramin Sarrafizadeh, Barry Schechter, Ori Segal, Scott Seo, Marco Setaccioli, Eric P Shakin, Jeffrey L Shakin, Ashish G Sharma, Yochai Shoshani, Shiri Shulman, Shiri Soudri-Zait, Giuliana Silvestri, Joanne Sims, Michael A Singer, Jack O Sipperley, Scott R Sneed, Glenn Stoller, Newman Sund, Homayoun Tabandeh, Barry Taney, Edgar L Thomas, Scott A Thomas, William Scott Thompson, Ron Tilford, Michelene Todd, Michael Trese, Tony Tsai, Adnan Tufail, Rafael Ufret-Vincenty, Hussein Wafapoor, Joseph P Walker, Alexander Walsh, Mark Walsh, Hao Wang, Dov Weinberger, Robert T Wendel, George Williams, Donald L Wilson, Glenn L Wing, Yanush Winkler, Richard Wintle, Tien P Wong, Sungjae Yang, Young-Hee Yoon, Leandro Zacharias, Yehoshua Zohar, Stephen Zuckerman
Abstract
Purpose: To evaluate the efficacy and safety of dexamethasone intravitreal implant 0.7 mg (DEX) as adjunctive therapy to ranibizumab in neovascular age-related macular degeneration (nvAMD).
Procedures: This was a 6-month, single-masked, multicenter study. Patients were randomized to DEX implant (n = 123) or sham procedure (n = 120) and received 2 protocol-mandated intravitreal ranibizumab injections. The main outcome measure was injection-free interval to first as-needed ranibizumab injection.
Results: DEX increased the injection-free interval versus sham (50th percentile, 34 vs. 29 days; 75th percentile, 85 vs. 56 days; p = 0.016). 8.3% of DEX versus 2.5% of sham-treated patients did not require rescue ranibizumab (p = 0.048). Visual acuity and retinal thickness outcomes were similar in DEX and sham-treated patients. Only reports of conjunctival hemorrhage (18.2 vs. 8.5%) and intraocular pressure elevation (13.2 vs. 4.2%) were significantly different in the DEX versus the sham treatment groups.
Conclusion: DEX reduced the need for adjunctive ranibizumab treatment and showed acceptable tolerability in nvAMD patients.
© 2015 S. Karger AG, Basel.
Source: PubMed